Behavior

Table 1: Detailed Description of Empirical Studies on the Drug Management Of Behavioral Symptoms in the

Cognitively Impaired

# Article Objectives Study Design Main Findings Discussion

Anticholinesterase Agents

Ott BR, Lapane KL To investigate:  Cross-sectional  For tacrine recipients: NH residents treated with

1  The extent to which retrospective cohort study.  35% had a diagnosis of AD. tacrine have lower mortality

―Tacrine therapy is treatment with  Setting: Data from the  34% had non-AD dementia. rates, a factor that has

associated with tacrine is associated Minimum Data Set on  30% had dementia with unspecified socioeconomic implications due

reduced mortality in with reduced 1,492 Medicare/Medicaid diagnosis. to cost implications associated

nursing home mortality in NH NH (>400,000 residents)  21% had mild dementia as assessed with prolongation of care.

residents with residents with in 5 states using the by the CPS. Doses of tacrine used were

dementia‖ dementia. SAGE database.  44% had moderate and 36% had generally less than those

 The distributions of  Time period: 1992-1996. severe dementia. reported to be efficacious in

Journal of the socioeconomic  Study population:  When compared to matched controls clinical trials, although there

American Geriatrics factors, functional  NH residents > 65 tacrine users were: may have been measurement

Society characteristics, and years receiving tacrine  More likely to be male; error associated with this

medication use in matched with 5 control  More likely to be receiving parameter.

2002;50(1):35-40. tacrine users and residents per case. antipsychotics or anxiolytics;

nonusers.  Size: N=1,449 tacrine  Less likely to have heart failure; The level of impaired behavior

users, N=6,119  Less likely to be malnourished as or ADLs is not known for the

nonusers. indicated by BMI; cohort, however tacrine

 Mean Age:  Severe ADL impairment was seen in 12% recipients were more likely than

 Tacrine users = 82.0 ± fewer tacrine users at baseline despite nonusers to be prescribed

7.2 years. comparable cognitive impairment. tranquilizers. The authors

 Nonusers = 84.0 ± 7.6  Of tacrine recipients: hypothesized this to be due to

years.  68% received doses 40mg/day. either a negative effect of

 Assessments include:  10% received >80mg/day. tacrine on quality of life or that

level of dementia  25% were treated for at least 6 tacrine was added to tranquilizer

(Cognitive Performance months. therapy to reduce existing

Scale-CPS), body mass  At the end of 36 months predicted survival behavioral problems.

index (BMI), and rates were:

activities of daily living  53.1% for patients receiving > 80mg a

(ADL). day of tacrine.

 47.3% for non-users.

 The effect of tacrine persisted when

adjusted for sociodemographic factors,

ADL function level, cognition, number of

drugs and comorbid illnesses.

 Tacrine users had a lower mortality rate

than nonusers over 3 years (hazard rate

ratio 0.76; 95% CI = 0.70-0.83) with the

maximum benefit seen in patients treated

with >80mg/day tacrine (HRR= 0.74; 95%

CI = 0.56-1.0).

Table 1: Detailed Description of Empirical Studies on the Drug Management Of Behavioral Symptoms in the

Cognitively Impaired

# Article Objectives Study Design Main Findings Discussion

Gifford DR et al. To describe:  Retrospective cross-  1640 (0.5%) NH residents received tacrine Tacrine is indicated for patients

2  The use of tacrine in sectional cohort study. at least once. with a diagnosis of AD who have

―Tacrine use in nursing all nursing homes  Population and setting:  1014 (62%) started treatment after mild to moderate dementia.

homes. Implications for (NH) in four US 329,520 residents of admission to the NH.

prescribing new states using data certified NHs in four states  Only 38% of tacrine recipients had a Between 1992-1995, physicians

cholinesterase from the Systematic using the SAGE database. documented diagnosis of AD on the MDS. rarely used tacrine in nursing

inhibitors‖ Assessment of  Time period: 1992-1995.  25% had severe cognitive impairment. homes. When it was used, it

Geriatric Drug Use  Study sample:  35% had severe ADL dependency.

was frequently given to patients

Neurology via Epidemiology  Size: for whom a benefit seemed

 17% had both severe ADL dependency

(SAGE) database. N=1,640 tacrine users; unlikely and generally at doses

and severe cognitive impairment at first

1999;52(2):238-44.  The demographic N=9,536 non-users. MDS assessment recording tacrine use.

below the recommended

and clinical NH residents > 65 years therapeutic dose of at least

 Dosages varied, but only 8% received ≥ 120mg day.

determinants of with at least one 120mg per day.

tacrine use. Minimum Data Set  Tacrine users were more likely than

(MDS) assessment matched controls to:

using the National Drug  Receive concomitant antipsychotics

Codes for tacrine or anxiolytics.

matched with five  Receive physical or occupational

control residents per therapy.

case.  Of tacrine users with more than one MDS

Mean age: assessment:

Tacrine users = 82.2 ±  46% discontinued therapy while in

7.3 years. the NH.

Nonusers = 84.2 ± 7.6  33% were intermittent users.

years.  21% remained on treatment

throughout their last MDS

assessment.

 Multivariate analysis showed four factors

were independently associated with

greater likelihood of receiving tacrine use:

 Wandering;

 Physically abusive;

 Medium levels of social engagement;

 High levels of social engagement.

 Patients were 25-40% less likely to receive

tacrine if they were:

 >85 years.

 Female.

 Had severe ADL impairment.

 Had bowel incontinence.

 Resided in a facility with a dementia

special care unit.

Table 1: Detailed Description of Empirical Studies on the Drug Management Of Behavioral Symptoms in the

Cognitively Impaired

# Article Objectives Study Design Main Findings Discussion

Woo JK et al. To investigate:  Prospective study of a  11 patients were assessed prior to and Although some patients

3  The efficacy and sample of older NH after the completion of tacrine therapy: improved on the ADAS

―Efficacy and tolerability of tacrine in residents with probable AD.  Five improved on the ADAS-cognitive cognitive subsection, PSMS

tolerability of tacrine in a sample of older NH  Setting: The Jewish Nursing subsection. and MMSE, there was a high

nursing home residents. Home & Hospital for the  Four improved on the MMSE. incidence of weight loss, poor

residents with Aged.  Three improved on the PSMS. appetite, and hepatotoxicity

Alzheimer‘s dementia‖  Study population:  Two of the 11 improved on all three necessitating treatment

 Size: N=20. tests. discontinuation. LFTs returned

Journal of the  Age range: 82-105 years.  Tacrine was discontinued in 19 patients: to normal following treatment

American Geriatrics  Dose: 40mg daily x 6  17 had a significant ADR (anorexia, discontinuation. The authors

Society weeks, titrating to 80, weight loss, elevated ALT). suggest that in this population,

120, 160mg at 6-week  One was non-compliant with therapy. it may be preferable to use

1996;44(11):1411-12. intervals if there were no  One was transferred for an unrelated maximum daily doses of 80 to

ADRs. event. 120mg rather than 160mg.

 Evaluation: Efficacy of  Four patients achieved the maximum daily

tacrine assessed using dose of 160mg, but only one patient was

the MMSE, Alzheimer‘s able to tolerate therapy for six weeks.

Disease Assessment

Scale (ADAS), and

Physical Self

Maintenance Scale

(PSMS).

Table 1: Detailed Description of Empirical Studies on the Drug Management Of Behavioral Symptoms in the

Cognitively Impaired

# Article Objectives Study Design Main Findings Discussion

Shua-Haim JR et al. To describe:  Retrospective medical  58-year-old female with 3-year history of This report provides anecdotal

4  The effect of record review (case notes). AD with severe cognitive (MMSE = 0) and evidence of functional

―Case report: donepezil in two  Setting: Outpatient N=1; functional impairment. Previously treated improvement in two patients

Donepezil in the patients with severe Nursing home N=1. with tacrine therapy that Behavioral with advanced AD (MMSE = 0)

treatment of advanced AD.  Time period: 1995-1996. symptoms managed with sertraline and when treated with donepezil

Alzheimer‘s disease‖  Treatment: Donepezil 5mg pindolol. Subjective improvement as rated therapy for three months.

daily for three months. by caregiver with donepezil treatment with

Annals of Long-Term improvements in verbal skills and Note: Ant-cholinesterase

Care reduction in functional impairment. therapy is indicated for palliative

 79-year-old male with severe cognitive treatment of mild to moderate

1999;7(2):67-71. (MMSE=0) and functional impairment and (MMSE = 10 to 26) primary

behavioral problems due to AD. degenerative dementia of the

Behavioral symptoms currently managed Alzheimer‘s type only.

with pindolol. After three months of

donepezil treatment, family noted

subjective improvement in cognition and

attention span. Katz activities of daily living

(ADL) scale showed improvement in

functional ability.





Barak Y et al. To evaluate:  Prospective 24-week open-  All patients completed the 24-week study There is evidence that donepezil

5 label study. period. may positively affect BPSD in

―Donepezil for the  The effect of  Setting: Psychogeriatric  Mean Mini-Mental Status Examination patients with a diagnosis of

treatment of behavioral donepezil as a single hospital ward. (MMSE) score: 13.3 ± 5.2. Alzheimer‘s disease. This was

disturbances in treatment for  Time period: January 1999 -  There were no adverse events warranting evidenced by a reduction in the

Alzheimer‘s disease: A Alzheimer‘s disease July 1999. drug discontinuation. presence of delusions,

6-month open trial‖ (AD) patients with  Study population:  Patients were hospitalized for a mean irritability/lability and

behavioral and  Size: N=10. period of 46.2±11.2 days. disinhibition, as well as overall

Archives of psychological signs of  Mean age: 74.9 ± 4.3  Significant decline in items on the NPI: BPSD severity and the distress

Gerontology and dementia (BPSD). years (range: 68-81).  Delusions: p3-point decline in

upwards until clinical MMSE score noted for two patients.

effect or significant  Treatment was well tolerated by all

ADRs. patients.

 Evaluations: Cohen-

Mansfield Agitation

Inventory (CMAI), Brief

Psychiatric Rating Scale

(BPRS), Global

Assessment of

Functioning (GAF), and

the MMSE.

Table 1: Detailed Description of Empirical Studies on the Drug Management Of Behavioral Symptoms in the

Cognitively Impaired

# Article Objectives Study Design Main Findings Discussion

Goldberg RJ To examine:  Retrospective medical  Primary target symptoms included Improvements were noted in

7  The effectiveness record analysis of all psychosis (41%); physical agitation or 54% of patients after 8 weeks of

―The use of adjunctive and tolerability of admissions within a 12- aggressiveness (68%); grossly divalproex therapy (range 6-12

divalproex for divalproex sodium in month period. disorganized behavior (26%); and/or weeks) with few problematic

neuroleptic reducing behavioral  Setting: Two nursing verbal disruption (55%). side effects.

unresponsive problems in patients homes.  Average MMSE pre-treatment: 10.5

disturbances in nursing with dementia who  Study population: (range: 0-24). The authors note that for the 10

home residents with have not responded to  Patients >65 years  Clinical outcomes rated by nursing staff patients that continued on

dementia‖ risperidone. started on divalproex for using a subjective global rating scale. neuroleptic treatment after the

dementia-related  Mean interval between initiating therapy divalproex trial, a reduction of

Annals of Long-Term behavioral problems who and assessment = 8 weeks (range: 6-12 neuroleptic dose was possible in

Care had failed to respond to weeks). three of the 10 patients.

a trial of risperidone (2-  Changes in patients behavioral symptoms:

1999;7(2):63-66. 4mg daily for at least  Much improved: N=6 (27%). Further double-blind placebo-

eight weeks).  Improved: N=6 (27%). controlled studies are required

 Size: N=22 (N=17 female,  Minimally improved: N=4 (18%). to substantiate the efficacy of

N=5 male).  Not improved: N=4 (18%). divalproex.

 Mean age: 83.1 years  Worse: N=2 (9%).

(range 70-91).  Adverse events that led to discontinuation

 Evaluations: MMSE and of therapy or reduction of dose included:

extrapyramidal  Excessive sedation (N=4).

symptoms (EPS) rating  Worsening of EPS (N=1).

score.  Increased agitation (N=2).

Table 1: Detailed Description of Empirical Studies on the Drug Management Of Behavioral Symptoms in the

Cognitively Impaired

# Article Objectives Study Design Main Findings Discussion

Porsteinsson AP et al. To examine:  Prospective, six week,  56 of 79 eligible patients participated in There is possible short-term

8  The efficacy, safety, randomized, multi-site the study (N=28 placebo, N=28 efficacy of divalproex sodium as

―Placebo-controlled and tolerability of placebo-controlled, parallel divalproex). evidenced by a statistically

study of divalproex divalproex sodium for group study.  71% had diagnosis of AD at baseline, significant difference in BPRS

sodium for agitation in agitation in dementia.  Setting: Seven LTC facilities 18% vascular dementia, 11% mixed agitation score and a difference

dementia‖  The primary in the Rochester, New York dementia. that approached significance on

hypothesis that area (size range 140-566  41 patients (73%) were receiving the CGI scale.

American Journal of administration of beds). psychotropics at baseline with a mean

Geriatric Psychiatry divalproex would  Study population: washout period of 11.7 ± 4.6 days. Further double-blind placebo-

reduce agitation as  Size: N=55.  Study discontinued by: controlled studies are required

2001;9(1):58-66. measured by the  Mean age: 85.0 ± 7.1  Two patients in divalproex arm (small to substantiate the efficacy of

Agitation factor of the years. bowel obstruction; RTI /UTI/ delirium/ divalproex.

Brief Psychiatric  Patients >60 years with a seizures).

Rating Scale (BPRS). diagnosis of probable or  Four patients in placebo arm

possible AD, vascular (increased agitation).

dementia, or mixed  Mean daily dose of divalproex at

dementia who had termination: 826 ± 216mg (range:

agitation for > 2 weeks 375mg-1375mg).

with a BPRS rating scale  Mean serum level of divalproex at

of >3 on items rating termination: 45.4 ± 14.9 g/mL, (range

tension, hostility, 22-85 g/mL).

uncooperativeness or  Total BPRS decreased 5.9 ± 6.6 on

excitement. placebo, 6.9 ± 8.2 on valproate (p=0.61).

 Dose: 375mg/day  Decrease in BPRS agitation factor of 2.3

increased by 125mg ± 2.5 on placebo, and 3.6 ± 2.9 on

every three days until divalproex (p=0.08). When analyzed

optimal response in the using ANCOVA, adjusting for a number

absence of toxicity. of covariates, there was a significant

 Evaluations: Brief effect for treatment (p=0.05).

Psychiatric Rating Scale

 No placebo/treatment differences were

(BPRS) and Clinical

noted on CGI. Using ANCOVA, the

Global Impressions

drug/placebo difference approached

Scale (CGI).

significance (p=0.06).

 Side effects were generally mild and

occurred more frequently in the treatment

(68%) vs. the control (33%) group as

assessed by the CGI (p=0.03).

Table 1: Detailed Description of Empirical Studies on the Drug Management Of Behavioral Symptoms in the

Cognitively Impaired

# Article Objectives Study Design Main Findings Discussion

Lott AD et al. To examine:  Prospective open-label trial  Clinical outcomes were rated by nursing This study suggests that

9  The efficacy and in consecutive elderly NH staff using a subjective global rating valproate may be an effective,

―Valproate in the safety of valproate in residents with dementia who scale. well-tolerated treatment for

treatment of behavioral dementia-related were referred by their  80% of patients displayed a 50% or greater dementia-related behavioral

agitation in elderly behavioral agitation. primary care physician for reduction in episodes of behavioral agitation in elderly patients.

patients with dementia‖ the evaluation and treatment agitation on valproate treatment.

of behavioral agitation.  Mean daily dose valproate = 525mg The authors note several

Journal of (range: 375mg-750mg). limitations of the study, including

Neuropsychiatry and  Study population:  Mean serum level of valproate: 36.8 the small size, absence of an

Clinical Neurosciences  Size: N=10. g/mL, (range 13-52 g/mL) instrument with documented

 Age range: 71-94 years.  Treatment was well tolerated by all reliability and validity to measure

1993;7(3):314-19.  Patients >65 years with a patients; adverse events did not limit behavioral agitation, the

diagnosis of dementia. dosing. subjective nature of the

 Valproate added to preexisting evaluation, use of multiple

psychotropic therapy in five patients, raters, open-label nature of the

enabling discontinuation of the trial, use of diagnostically

psychotropic medication without heterogeneous population of

recurrence of agitation in all five patients. patients, and potential for

concomitant psychotropic

therapy.



Porsteinsson AP et al. To assess:  Prospective, open-label,  Diagnosis at baseline: This study indicated the possible

10  The efficacy, pilot study.  Alzheimer‘s disease: N=7. benefit of valproate in the

―An open trial of tolerability, and safety  Setting: Three LTC facilities  Vascular dementia: N=4. management of agitation in

valproate in geriatric of valproate in elderly in Rochester, New York.  Dementia NOS: N=1. elderly patients.

neuropsychiatric patients with agitation  Study population:  Mental retardation: N=1. Improvement in agitation level

disorders‖ and neuropsychiatric  Size: N=13 (N=12  11 patients (73%) were receiving stable was noted for over 50% of

disorders. dementia). doses of psychotropics at baseline. patients. Improvements were

American Journal of  Mean age: 81.6 years  Treatment discontinuation: noted at a variety of dose and

Geriatric Psychiatry (range 65-97).  Drowsiness, gait disturbance and serum levels, indicating a need

 Agitated nursing home apraxia: N=1. to individualize treatment.

1997;5(4):344-51. patients with  Worsening agitation: N=1. Treatment was generally well

neuropsychiatric  Mean daily dose of divalproex at tolerated.

disorders especially termination: 802mg (250-1500mg).

dementia.  Mean serum level of divalproex at The study interpretation is

 Treatment: valproate termination: 54 g/mL, (33-107 g/mL). limited by the small sample size,

125mg twice daily orally  Treatment duration: 5-21 weeks. open-label design, variability of

titrating upwards dose and treatment duration,

 Improvement in agitation at trial end:

depending on response and the concomitant use of

 Marked improvement: N=2.

and tolerability. psychotropic agents.

 Moderate improvement: N=5.

 Evaluation: Clinical  Minimal improvement: N=2.

Global Impression of  No change: N=2.

Change (CGIC).  Minimally worse: N=1.

Table 1: Detailed Description of Empirical Studies on the Drug Management Of Behavioral Symptoms in the

Cognitively Impaired

# Article Objectives Study Design Main Findings Discussion

Hawkins JW et al. To examine:  Retrospective medical  Mean MMSE score at baseline = 7 (range Gabapentin seemed promising

11  The use of record chart review. 0-28). and well-tolerated in the

―A retrospective chart gabapentin for the  Setting: Nursing home  23 of the 24 patients documented to have treatment of aggressiveness

review of gabapentin treatment of patients at a large VA behavior refractory to previous and agitation in nursing home

for the treatment of aggressive and hospital. psychotropic treatment (including patients with dementia.

aggressive and agitated behaviors in  Study population: neuroleptics, other anti-epileptic agents).

agitated behavior in nursing home patients  Size: N=24 (all male).  Behavioral problems at baseline: Randomized clinical controlled

patients with with DSM-IV  Mean age: 71.2 ± 10.5  Verbal aggression N=11. trials are required to confirm

dementias‖ diagnosis of years (range 50-99).  Physical aggression N=20. efficacy.

dementia.  Evaluation: Clinical  Sexual aggression N=2.

American Journal of Global Impressions  Other aggressive behavior N=10.

Geriatric Psychiatry Scale (CGI).  Average daily dose gabapentin = 1318mg

(range 300mg-3600mg).

2000;8(3):221-25.  Treatment duration range: four weeks to

more than two years.

 Therapy discontinued in two patients due

to excessive sedation.

 Behavior rated after four weeks using the

CGI Scale

 17 (70.8%) patients were much

improved or very much improved.

 Four (16.7%) patients rated as

minimally improved.

 One (12.5%) patient ‗s behavior

unchanged.

Table 1: Detailed Description of Empirical Studies on the Drug Management Of Behavioral Symptoms in the

Cognitively Impaired

# Article Objectives Study Design Main Findings Discussion

Tariot PN et aI. To assess:  Prospective, six-week  Behavioral target symptoms at baseline: Carbamazepine appears to be

12  The efficacy, safety, randomized, multi-site,  Verbal disruption N=47. effective and safe in the short-

―Efficacy and and tolerability of parallel group study.  Physical disruption N=36. term treatment of some

tolerability of carbamazepine in the  Setting: Four LTC facilities  Sexual inappropriateness N=16. demented patients with severe

carbamazepine for treatment of ranging in size from 350 to  Aggression N=47. agitation.

agitation and aggression associated 600 beds in Rochester, N.Y.  Mean MMSE score at baseline: 6.0 ± 7.0.

aggression in with dementia.  Study population:  Trial was discontinued by four patients in The change in agitation was

dementia‖  Patients > 60 years old the carbamazepine arm (N=1 associated with a significant

with dementia and a tics/sedation; N=3 agitation). decrease in staff‘s perception of

American Journal of minimum two week  Dose reduction related to adverse events time required to manage

Psychiatry history of agitation of in five additional patients. agitation for the carbamazepine,

BPRS score >3.  Mean daily dose at six weeks = 304mg ± but not the placebo group.

1998;155(1):54-61.  Size: N=51 (N=24 119.

placebo; N=27  Mean serum level = 5.3g/mL (range 3.5- This may have cost implications.

carbamazepine). 7.6). Auto-induction of metabolism by

 Dose: 100mg daily  Statistically significant reduction in total carbamazepine and multiple

increasing by 50mg BPRS score with carbamazepine drug-drug interactions may

every 2-4 days until a compared to placebo (p=0.0003). complicate use of this agent.

serum level of 5-8g/mL  Significant reduction noted with

maintained, otherwise carbamazepine therapy compared to

highest sub-toxic dose placebo in the mean agitation factor

used. (p=0.0001) and the hostility factor

 Evaluations: Brief (p=0.0007) of the BPRS:

Psychiatric Rating Scale  Significant difference between placebo and

(BPRS), Clinical Global carbamazepine groups on CGI at six

Impressions Scale (CGI), weeks (p=0.001).

Overt Aggression Scale  Change in CGI for placebo group:

(OAS).  At least minimally improved = 21%

 Unchanged / worse = 79%.

 Change in CGI for carbamazepine group:

 At least minimally improved = 77%

 Unchanged / worse = 23%.

 Significant difference in change in OAS

between placebo (mean = 1.9) and

carbamazepine (mean = 6.7) at six

weeks. (p=0.008).

 Significant difference in adverse events

(p=0.03), which were more common in

the carbamazepine group, but only

clinically significant in two cases.

Table 1: Detailed Description of Empirical Studies on the Drug Management Of Behavioral Symptoms in the

Cognitively Impaired

# Article Objectives Study Design Main Findings Discussion

Selective Serotonin Reuptake Inhibitors

Kim KY et al. To report:  Case report.  59-year old white male with verbal agitation There was a significant

13  The effect of  Setting: Extended care refractory to multiple psychotropic reduction in verbal agitation in

―Citalopram for verbal citalopram on verbal psychiatric program at medications. Patient previously two patients with AD-related

agitation in patients agitation in patients Veterans Affairs Medical stabilized on valproic acid for physical dementia when treated with

with dementia‖ with AD-related Center. aggression. MMSE = 0. Improvement citalopram. Treatment was well-

dementia.  Study population: noted after 10 days treatment with tolerated.

Journal of Geriatric  Size: N=2 (male). citalopram 20mg daily; considerable

Psychiatry and  Ages: 59 years, 62 years. reduction in verbal agitation with dose It is possible that verbal

Neurology increase to 40mg daily. Symptoms agitation in dementia is related

reemerged five days after discontinuing to depression and anxiety,

2000;13(2):53-55. therapy (had difficulty swallowing pills), conditions known to be

 62-year-old black male with concomitant responsive to SSRIs. In these

diagnosis of chronic paranoid cases, the interdisciplinary team

schizophrenia symptom-free on did not conclude that depression

olanzapine. Verbal agitation refractory to or anxiety were contributing

trials of other psychotropic agents. factors to the verbal agitation,

MMSE = 5. Patient started on citalopram however the diagnosis may be

20mg/day, increasing to 40mg/day after complicated by the presence of

seven days. Improvement noted within severe cognitive impairment.

10 days, overall approximately 80%

improvement in verbal agitation.



Ramadan FH et al. To examine:  Prospective study.  At baseline, 53% had severe cognitive Paroxetine may be of benefit in

14  The safety and  Setting: Two nursing homes (MMSE 13). in nursing home patients with

agitation with a as an alternative to clinic.  Baseline CMAI for all NH residents = 7. For severe cognitive impairment.

selective serotonin neuroleptic therapy for  Study population: outpatient cohort, four had a score of 5, 87% of patients (13/15)

reuptake inhibitor‖ the treatment of  Size: N=15 (N=8 NH three a score of 6. achieved an adequate clinical

verbal agitation in residents).  Mean daily dose of paroxetine: response (CMAI 3).

Journal of Geriatric demented patients.  Mean age: 79 ± 9.8  Nursing home: 27.5 ± 8.9 mg.

Psychiatry and years.  Outpatient group: 15.7 ± 5.3 mg. It is theorized that verbal

Neurology  Patients with clinical  CMAI item scores reduced 43-57% at end agitation in demented patients

diagnosis of AD or of month one for nursing home residents could represent an unusual

2000;13(2):56-59. vascular dementia. and 50-67% in outpatient group. manifestation of depression.

 Dose: Paroxetine 10mg  Number of patients with CMAI score 3:

daily titrated upward by  N=8 at month one.

10mg at two-week  N=13 at month three.

intervals (to 40mg/day).  Therapy was well-tolerated. Dose reduced

 Evaluations: MMSE, from 20mg to 10mg in two patients for

Cohen-Mansfield worsening of Parkinson‘s tremor and

Agitation Inventory diarrhea.

(CMAI), Katz index score

(KIS).

Table 1: Detailed Description of Empirical Studies on the Drug Management Of Behavioral Symptoms in the

Cognitively Impaired

# Article Objectives Study Design Main Findings Discussion

Ramadan FH, To examine:  Prospective open-label  Mean MMSE score = 2.5 (range 1-10). This study indicates a clinically

15 Naughton BJ  The effect of study.  All patients had a baseline individual CMAI measurable benefit of

paroxetine on verbal  Setting: Two nursing homes item score = 7. paroxetine in reducing treatment

―Paroxetine for verbal agitation in nursing in Buffalo, NY.  Mean baseline total CMAI score = 13. refractory verbal agitation in

agitation‖ home residents.  Study population:  Average reduction of total CMAI score from nursing home patients with

 Consecutive patients baseline: dementia.

Annals of Long-Term exhibiting verbal  Month 1: 62% (mean score = 5).

Care agitation.  Month 3: 70% (mean score = 4).

 Size: N=15.  Average monthly VS:

1999;7(7):282-86.  Mean age: 79 ± 9.8 years  Baseline = 90.

(range: 68-89).  Month 1: range 20-60 (22-78%

 Patients with clinical reduction).

diagnosis of dementia  Month 3: VS =0 (N=10) 100%

with MMSE 7 after treatment

>6 (items 22, 24, 26 or compared to baseline (N=9 versus N=1;

29), and behavior p 65 years:

paroxetine 10 mg daily.

 Patients assessed using

CMAI score and also

Verbalization Score (VS).

VS records presence or

absence of behavior in

each of the 3 daily

nursing shifts, maximum

possible daily score = 3.

Table 1: Detailed Description of Empirical Studies on the Drug Management Of Behavioral Symptoms in the

Cognitively Impaired

# Article Objectives Study Design Main Findings Discussion

Ragneskog H et al. To evaluate:  Prospective open-label  123 of 148 patients included in analysis. 60% of patients showed

16  The long-term safety, study. (25 discontinued therapy in month one: significant clinical improvement

―Long-term treatment tolerability, and  Setting: Two LTC centers N=2 died; N=13 nonadherence; N=5 in emotional disturbances with

of elderly individuals efficacy of citalopram and a psychogeriatric clinic side-effects; N=5 insufficient efficacy). citalopram treatment.

with emotional in the treatment of in Sweden.  CGI scale: statistically significant reduction

disturbances: An open elderly patients with  Study population: in symptoms at months 1,3,5, and 7 Selective premature

study with citalopram‖ emotional  Size: N=148. (p (p 3 on any of the  Proportion of patients completing 6-weeks

agitation/aggression treatment: Olanzapine is generally well-

Archives of General hallucinations or  Placebo: 76.6%. tolerated with the exception of

Psychiatry delusions items of the  Olanzapine 5mg: 80.4%. dose-related somnolence.

Neuropsychiatry  Olanzapine 10mg: 72.0%.

2000;57(10):968-76. inventory-nursing home  Olanzapine 15mg: 66.0%. The olanzapine 15mg dose had

version (NPI/NH).  Improvement noted for all treatment groups a negative effect on tolerability

 Size: N=206. relative to placebo. Response rates and possibly reduced efficacy,

 Mean age: 82.8 years. (NPI/NH Core Total score): relative to the lower doses used.

 Treatment group:  Placebo: 35.6%.

Olanzapine 5mg, 10mg  Olanzapine 5mg: 65.5% (p=0.005). Concern exists about the

or 15 mg daily.  Olanzapine 10mg: 57.1% (p=0.04). potential of cognitive decline

 Concomitant psychotropic  Olanzapine 15mg: 43.1% (p=0.53). when using agents with anti-

therapy except rescue  Significantly greater mean score cholinergic properties (including

benzodiazepine therapy reductions for olanzapine 5mg and 10mg olanzapine) in this cohort. No

prohibited. compared with placebo on the significant decline in cognitive

 Evaluations: Brief agitation/aggression item and the psychosis function was noted over the 6-

Psychiatric Rating Scale total items of the NPI/NH. week trial.

(BPRS) and MMSE.  Significant reduction in caregiver distress

 NPI/NH total score used (measured by the sum of the occupational

to classify patients as disruptiveness scores) for olanzapine 5mg

responders > 50% cohort compared to placebo.

reduction from baseline  Significant improvement in BPRS total

and nonresponders. score with olanzapine 5mg compared to

placebo.

 Treatment discontinuations due to adverse

events:

 Placebo: N=2.

 Olanzapine 5mg: N=6.

 Olanzapine 10mg: N=4

 Olanzapine 15mg: N=9.

 No significant change in MMSE scores

from baseline noted for any of the

olanzapine groups.

Table 1: Detailed Description of Empirical Studies on the Drug Management Of Behavioral Symptoms in the

Cognitively Impaired

# Article Objectives Study Design Main Findings Discussion

Street JS et al. To determine:  Prospective 18-week, open-  Mean baseline MMSE = 7.0 ± 6.9. This study showed continued

19  The long-term safety label, multicenter extension  Mean change in MMSE: -0.7 ± 3.8 improvement in behavioral and

―Long-term efficacy of and efficacy of study (that followed a 6- (p=0.108). psychotic symptoms of AD

olanzapine in the olanzapine in the week randomized, double  67% of patients (N=70) completed 18- patients in nursing homes

control of psychotic treatment of psychotic blind, placebo-controlled weeks of therapy. treated with olanzapine at a

and behavioral symptoms and study).  Mean exposure duration = 104 days. modal dose of 7mg.

symptoms in nursing behavioral  Setting: US nursing homes  Modal dose = dose that the patient was

home patients with disturbances due to (28 different sites). prescribed for the most number of days. Olanzapine was generally well-

Alzheimer‘s disease‖ AD in elderly nursing  Study population: Overall mean modal dose = 7.0mg. tolerated except for somnolence

home patients.  Size: N=105.  Range of modal doses of olanzapine: and accidental injury. No

International Journal of  Mean age: 83.4 ± 6.6  Placebo: 2.9% (i.e. patients that significant changes seen in

Geriatric Psychiatry years. discontinued therapy). ECG, weight, or vital signs

 AD patients with a score  Olanzapine 5mg: 66.7%. (including orthostasis).

2001;16(Suppl. > 3 on the  Olanzapine 10mg: 21.0%.

1):S62-70. agitation/aggression  Olanzapine 15mg: 9.5%. Concern exists about the

hallucinations or  Response rate (reduction in NPI/NH Core potential of cognitive decline

delusions items of the Total score). when using agents with anti-

NPI/NH and had  Responders: 47.6%. cholinergic properties (including

received olanzapine in  Mean baseline score: 7.9. olanzapine) in this cohort. No

the 6-week lead in study.  Mean endpoint score: 6.0 (p=0.002). significant decline in cognitive

 Dose: Olanzapine 5mg function was noted over the 18-

 Significant improvement in mean scores for

daily increasing at 5mg week trial.

individual items in the NPI/NH:

every seven days to a  Agitation/Aggression: -1.2 ± 3.5;

maximum of 15mg. This study was limited by open-

(p=0.001).

 Concomitant psychotropic label nature, lack of comparator,

 Delusions: -0.6 ± 2.4 (p=0.024).

therapy except rescue unrestricted use of concomitant

 Disinhibition: -0.7 ± 2.3 (p=0.007).

benzodiazepine therapy benzodiazepines, and the use of

 Irritability/lability: -1.2 ± 3.5 (p=0.002).

prohibited. a flexible dosing schedule.

 Occupational disruptiveness: -0.7 ±

 NPI/NH Core Total score 2.2 (p=0.003).

used to classify patients  Significant improvement in BPRS total

as responders with > score noted compared to baseline

50% reduction from (p=0.009).

baseline being classified  Significant improvement in CGI-S total

as a response. score noted compared to baseline

 Evaluations: in Brief (p=0.027).

Psychiatric Rating Scale

 Adverse events with an incidence > 15%:

(BPRS) and Clinical

 Somnolence: 27.6%.

Global Impressions

 Accidental injury: 24.8%.

Severity of AD (CGI-S).

 Rash: 18.1%.

 Increased cough: 17.1%.

 Weight loss: 16.2%.

 Rhinitis: 15.2%.

Table 1: Detailed Description of Empirical Studies on the Drug Management Of Behavioral Symptoms in the

Cognitively Impaired

# Article Objectives Study Design Main Findings Discussion

Mintzer J et al. To assess:  Post hoc analysis of  Mean baseline MMSE = 7.4 ± 6.2; with The authors conclude that low-

20  The efficacy and previous study (6-week 70.83% of patients severely cognitively dose olanzapine (5mg) is

―Olanzapine in the tolerability of randomized, double-blind, impaired (MMSE10). superior to higher doses of

treatment of anxiety olanzapine in the placebo-controlled study).  Mean baseline NPI/NH anxiety scale olanzapine (10mg and 15mg),

symptoms due to treatment of  Setting: US nursing homes score: 7.2 ± 3.1 with higher baseline scores and to placebo in the treatment

Alzheimer‘s disease: A significant anxiety (28 different sites). in females compared to males (7.6 vs. 6.2). of anxiety symptoms in nursing

post hoc analysis‖ symptoms (>2 on the  Time period: 12/96-6/98.  Prevalence of item scores > 3 on NPI/NH home residents with Alzheimer‘s

NPI/NH Anxiety item)  Study population: subscale score: disease.

International Journal of in patients with AD.  AD patients age >40  Agitation/aggression: 95.0%.

Geriatric Psychiatry  The safety of years with a score > 3 on  Delusions: 65.0%. The improvement in anxiety

olanzapine in patients any of the aggression  Hallucinations: 29.2%. symptoms persisted, controlling

2001;16(Suppl. 1): >85 years compared hallucinations or  Depression: 44.2%. for improvements in

S71-77. to those 2 on the anxiety p=0.034). Improvement remained Olanzapine was tolerated at

item. statistically significant when controlled for least as well in patients >85

 Size: N=120 (N=70 improvement in hallucinations (p=0.024) years compared to those 85 years. (p=0.044).

 Mean age: 82.8 years  91/120 (76%) of patients completed 6-

(range: 61-97) weeks treatment. Reasons for treatment

 Random assignment to discontinuation included:

placebo, olanzapine  Adverse events: N=11.

5mg, 10mg, or 15 mg  Lack of efficacy: N=5.

daily.  Somnolence the only treatment-emergent

event statistically different in olanzapine any

group compared to placebo:

 Placebo: 3.7%.

 Olanzapine 5mg: 25% (p=0.034).

 Olanzapine 10mg: 23% (p=0.054).

 Olanzapine 15mg: 26% (p=0.050).

 Sub-group analysis of statistically

significant adverse events in patients > 85

years compared to those 6 on Cognitive decline was noted in

 Significant improvement CMAI score

one item, or >41 on the several patients as indicated by

(P0.5mg twice daily.

 Treatment discontinued in 46 patients:

 N=29 ineffective.

 N=9 excessive sedation.

 N=3 falls due to treatment induced

postural hypotension.

 N=2 agitation.

 N=3 miscellaneous (rash, urinary

retention, increase in EPS).

 Clinical effectiveness of risperidone

assessed by nurse rating of global

behavioral at intervals for up to 6-months.

Of 100 patients, risperidone reported to be:

 N=38: very helpful.

 N=26: moderately helpful.

 N=17: slightly helpful.

 N=19: not helpful.

Table 1: Detailed Description of Empirical Studies on the Drug Management Of Behavioral Symptoms in the

Cognitively Impaired

# Article Objectives Study Design Main Findings Discussion

Katz IR et al. To evaluate:  Prospective, 12-week,  12 weeks treatment completed by 435 / Risperidone 1mg and 2mg was

23  The safety and double blind, placebo- 625 patients (70%). significantly more effective than

―Comparison of efficacy of risperidone controlled study.  Treatment discontinuation primarily due to placebo in reducing behavioral

risperidone and in the treatment of  Setting: 40 nursing homes adverse events (15.4%): and psychiatric symptoms in this

placebo for psychosis psychotic and and chronic disease  Placebo: 12%. cohort of severely demented

and behavioral behavioral symptoms hospitals in the US.  Risperidone 0.5mg daily: 8%. LTC patients.

disturbances in institutionalized  Time frame: July 31, 1995 –  Risperidone 1.0mg daily: 16%.

associated with elderly patients with March 7, 1997.  Risperidone 2.0mg daily: 24%. There were substantial

dementia: A dementia.  Study population:  Treatment discontinued by 31 patients improvements in the severity

randomized, double-  Size: N=625; (N=424 (5%) due to inadequate response). and frequency of aggressive

blind trial‖ female).  Mean baseline MMSE score = 6.6 ± 6.3. behavior in patients receiving

 Mean age: 82.7 ± 7.7  Categorical response was defined as a 1mg and 2mg risperidone

Journal of Clinical years. ≥50% reduction in BEHAVE-AD total score. compared to placebo.

Psychiatry  Nursing home or chronic Statistically significant results as compared

disease hospital to placebo were: The use of risperidone did not

1999;60(2):107-15. residents > 55 years old  Placebo: 33%. cause significant changes in

with diagnosis of AD,  Risperidone 1mg daily: 45% (p=0.02). cognitive or self-care

vascular disease, or a  Risperidone 2mg daily: 50% (p=0.02). performance.

combination of the two;  Significant improvements noted for all

an MMSE  23; three risperidone groups compared to Treatment was generally well-

Behavioral Pathology in placebo on the BEHAVE-AD aggression tolerated, although more side

Alzheimer‘s disease subscale score at week 12. effects were noted for patients

(BEHAVE-AD) rating  Post hoc analysis of 257/625 patients rated receiving risperidone 2mg daily.

scale total score >8 and as physically violent at baseline (baseline Therefore the optimal effective

a global rating >1. score >2 on the physical threats of violence dose appears to be 1mg daily.

 Treatment: placebo, item of the aggressiveness subscale).

risperidone 0.5mg, Patients improved (score 0 or 1) at endpoint The heterogeneity of the patient

1.0mg or 2.0mg daily. (significance compared to placebo): population, with regard to cause

 Concomitant psychotropic  Placebo: 42%. of dementia, may limit the ability

therapy prohibited except  Risperidone 0.5mg: 54%. to draw pathophysiological

rescue lorazepam (up to  Risperidone 1mg: 68% (p=0.06). conclusions. However, this

end of week 4), chloral  Risperidone 2mg: 71% (p=0.02). study mirrors the ―real world‖

clinical context in which patients

hydrate and benztropine  Significant improvement in CMAI verbal,

for extrapyramidal are treated.

physical and total aggression score at week

symptoms. 12 and endpoint compared to placebo noted

 Evaluation: MMSE, for risperidone 1mg (p=0.006) and 2mg

BEHAVE-AD, Cohen- (p 65 years (p4mg

Psychogeriatrics not currently receiving respectively. daily haloperidol and >75mg

benzodiazepine therapy.  Risperidone had a greater effect than daily thioridazine), perhaps

1997;9(4):431-35.  Patients treated with thioridazine on total behaviors and on reflecting the lack of tolerability

haloperidol (N=83), violence, shouting, paranoia, and mixed of these agents at these doses.

risperidone (N=60), or behaviors.

thioridazine (N=43) for  Risperidone had a greater effect than This study was limited by its

the target behaviors of haloperidol on all target behaviors (except retrospective nature, lack of

violence (N=64), pacing where all three patients improved). control group, lack of

shouting (N=31),  Treatment failures: standardized rating instruments,

delusions (N=26),  Haloperidol: N=28 (34%) – 23 and possible poor inter-rater

paranoia (N=19), pacing switched to risperidone and 5 to reliability.

(N=3), and mixed thioridazine and all improved.

behaviors (N=33).  Risperidone: N=3 (5%) – all switch to

 Improvement in behavior haloperidol and all improved.

obtained from physician  Thioridazine: N=15 (35%)- 12

and psychiatric reports, switched to risperidone and three to

nurse summaries and by haloperidol and all improved.

comparison of the  Final median daily dose in patients that

number of incidents per improved:

month on nurse  Haloperidol: 1mg (92% got 41 on the CMAI total CMAI scores of patients with higher symptoms of agitation and

score or with an baseline HAM-D scores and in those with aggression with trazodone

individual item score >6. greatest HAM-D score improvements. treatment appear to be at least

 Patients randomized to Change in CMAI score also dependent on partly dependent on its effect on

receive trazodone 50mg baseline Delusion scale score (greater in mood, with patients who have

daily or haloperidol 1mg those with higher baseline score) and on mild depressive symptoms

daily adjusted to effect changes in Delusion scale score (greater in improving most.

over the first three weeks patients with higher Delusion scale score

to a maximum of improvement). Effect of baseline Delusion

trazodone 250mg daily scale score on CMAI score did not persist

or haloperidol 5mg daily. after controlling for baseline CMAI scores.

 Patient behavior Improvements in CMAI score also

assessed using CMAI, correlated with the severity of mood

Hamilton Depression symptoms and more severe

Rating Scale (HAM-D), neurovegatative state at baseline. Patients

and BEHAVE-AD. with more depressed mood at baseline had

greater improvements in CMAI with

trazodone treatment.

Table 1: Detailed Description of Empirical Studies on the Drug Management Of Behavioral Symptoms in the

Cognitively Impaired

# Article Objectives Study Design Main Findings Discussion

Gaber S et al. To evaluate:  Prospective, 10-week,  Significant improvement in agitation The authors concluded that

31  The efficacy and randomized, double blind behavior from baseline noted for both sertraline may represent a

―Sertraline versus tolerability of sertraline trial. sertraline and haloperidol groups (p60 score for patients treated with selegiline modalities that reflect the

Journal of Psychiatry years with diagnosis of versus placebo who had normal but not prefrontal brain area function

and Neuroscience mild-moderate dementia. pathologic CDTs at baseline. may be evidence of the

 Size: N=173.  Significant improvement (p=0.002) after 12 mechanism of action of

1999;24(3):234-43.  Dose 10mg/day selegiline and 24 weeks in Sternberg‘s Memory selegiline, as these areas are

or placebo for 24 weeks. Scanning test with selegiline for patients rich in dopamine receptors.

 Patients stratified for with pathologic but not normal CDTs at The differential responses

disease severity based baseline. based on the stratification

on pre-treatment Clock  In patients with pathologic, but not normal according to CDT may reflect

Drawing Test (normal or CDTs at baseline, there was a modest differences in the sensitivity of

pathologic decrease in the dominant EKG activity in psychometric tests to change

 Evaluations: Clinical the selegiline group, and a profound depending on the level of

Global Impressions decrease in the placebo group (p=0.019) dementia.

Scale (CGI), MMSE, and after 6 months.

the pathological Clock-  No significant difference in adverse events

Drawing Test (CDT). noted between selegiline and placebo

groups.

Table 1: Detailed Description of Empirical Studies on the Drug Management Of Behavioral Symptoms in the

Cognitively Impaired

# Article Objectives Study Design Main Findings Discussion

Kyomen HH et al. To investigate  Prospective, 4-week,  14 of 15 patients completed study (N=8 This study provided preliminary

35  The safety and randomized, placebo- treatment, N=6 placebo), one patient was evidence of the safety and

―Estrogen therapy and efficacy of short-term controlled trial. withdrawn due to severe tardive dyskinesia. efficacy of estrogen therapy in

aggressive behavior in estrogen therapy in  Setting: Unit for severely  Mean baseline MMSE = 4.7 ± 7.9. the management of aggressive

elderly patients with decreasing behaviorally disturbed  Mean baseline TSI score = 9.1 ± 6.8 behaviors in elderly patients with

moderate-to-severe aggressive behavior patients in a LTC institution  Mean baseline ADL score: 21.7 ± 2.5. dementia.

dementia‖ in patients with in Boston, MA.  Based on ABS rating at 4-weeks,

moderate-to-severe  Study population: comparing estrogen therapy to placebo: Estrogen therapy appeared to

American Journal of dementia.  Patients > 60 years with  Significant improvement noted for reduce total aggressive behavior

Geriatric Psychiatry  Primary hypothesis: a diagnosis of dementia estrogen group compared to the within one week of treatment.

Patients treated with and at least three placebo group (p = 0.03). The four different doses of

1999;7(4):339-48. estrogen would have aggressive incidents.  Significant reduction in physical estrogen appear to have

a reduction in scores  Size: N=15 (N=13 aggression subscale rating (p60 years with a studies have shown

MMSE  24. improvement in orientation or

 Intervention: Patients behavior. The disparity in the

were divided into two results could be due to a variety

sub-samples A and B. of patient mixes and the lack of

The RO group and the detailed guidelines for

VT group within each structuring a RO program.

sub-sample received

four months of The results of validation therapy

structured therapy in a were consistent with another

classroom setting (30 study on VT that found no effect

minutes five times a on the patient status.

week). The control

groups received no The authors note a number of

therapy. study limitations including: that

 Evaluation: MMSE, therapy was structured in a

functional status (ADL), specific time frame as opposed

levels of depression to a ongoing therapy, small

(Modified Beck sample size, lack of

Depression Inventory). randomization and the lack of

control of concomitant

medications.

Table 2: Detailed Description of Empirical Studies on Non-Drug Behavioral Interventions in the Cognitively

Impaired





# Article Objectives Study Design Main Findings Discussion

Behavior Therapy II: Differential Reinforcement

Rogers JC et al. To examine:  Prospective study with  A significant increase in the time participants Behavioral interventions in

65  The effectiveness of patients acting as their engaged in self-dress was noted. (15% nursing home residents with

―Improving morning behavioral own control. during usual care, to 41% during skill Alzheimer type and related

care routines of nursing rehabilitation  Setting: Five nursing elicitation.) dementias produced a

home residents with intervention in homes in Pittsburgh,  Functional gains were seen within five days significant increase and

dementia‖ improving the Pennsylvania. of initiating the intervention and were improvement in ADL

performance of  Study population: maintained for three weeks during Habit participation, and a decrease in

Journal of the American morning-care  Sample size: N=84 Training. disruptive behaviors.

Geriatrics Society activities of daily (N=58 females).  The mean rate of nondirective assists was

living (ADL) of  Mean age = 82.0 ± 6.3 greatest during No ADL, whereas for the The authors note that functional

1999;47(9):1049-57. nursing home years. Skill and Habit conditions it was greatest gains were seen in both the staff

residents with  Residents with a during Dress. and residents, but that the gains

dementia. diagnosis of dementia  Physical assists were provided in were achieved at the cost of

and a dressing significantly smaller proportions during Skill doubling caregiver time.

disability. Elicitation and Habit Training compared

 Intervention: Observation with Usual Care.

of participants and  Disruptive behavior decreased significantly

caregivers under three during Skill Elicitation (p=0.01) and

conditions: usual care (5 increased slightly during Habit Training.

days), skill elicitation (15

days behavioral

rehabilitation therapy to

identify and retain ADL

skills), and habit training

(15 days follow-up

period with

reinforcement of

behavioral

rehabilitation).

 Three ADL categories

observed: dressing

(dressing performance),

other ADL (bathing,

toileting, oral hygiene,

grooming and no ADL

(inactivity or mobility).

Table 2: Detailed Description of Empirical Studies on Non-Drug Behavioral Interventions in the Cognitively

Impaired





# Article Objectives Study Design Main Findings Discussion

Staff/Staff Training

Proctor R et al. To examine:  Prospective, 6-month,  105/120 patients completed the 6-month- This study showed a benefit in

66  The impact of an old- placebo-controlled trial. trial. using a combined education and

―Behavioural age psychiatry  Setting: Two nursing  At study endpoint, there was a significant training program in improving

management in nursing outreach team on homes and 10 residential improvement in depression (p=0.04) and quality of care in nursing and

and residential homes: the quality of care in homes in south cognitive impairment scores (P=0.002) for residential homes.

a randomised controlled nursing and Manchester, UK. the treatment group compared to the

trial‖ residential.  Study population: control group. Significant improvements were

 Study size: N=120 (N=98  There was no significant difference in scores noted in depression and

Lancet female). for behavioral rating or functional ability cognitive impairment scores in

 Mean age: 83.1 years between the two groups at 6-month follow- the treatment group compared

1999;354(9172):26-29. (range 81-84). up. to the control group. However,

 Selection of 10 patients  At follow-up, when adjusted for baseline no improvement was noted in

with behavioral measures, there was a significant reduction behavioral rating or functional

problems in each in the mean number of visits by a general ability of residents.

center. Centers (primary) practitioner in the intervention

randomized to receive group compared to the control group

treatment (staff training (p=0.027).

and psychosocial

management of

resident‘s behavioral

problems) or standard

care.

 Study evaluation:

Comparison of

resident‘s organic and

depression symptoms,

behavioral

characteristics, physical

disability, and resource

utilization (doctor visits,

use of hospital services,

and prescription

medications for

intervention and control

groups).

Table 2: Detailed Description of Empirical Studies on Non-Drug Behavioral Interventions in the Cognitively

Impaired





# Article Objectives Study Design Main Findings Discussion

McCallion P et al. To evaluate:  Prospective 2 (intervention  Mean resident‘s MMSE score at baseline: This study provides preliminary

67  If a Nursing Assistant conditions) x 2 (skilled  Treatment group: 6.3 ± 6.6. evidence that NACSP training is

―Educating nursing Communication nursing homes) x 4  Control group: 4.9 ± 6.0. an effective in-service training

assistants to Skills Program (assessments) nested  Significant improvement in behavioral program that positively impacts

communicate more (NACSP) improves partial crossover control disturbance and ideation disturbance interactions between nursing

effectively with nursing the well-being of group design. subscale of the CSDD for residents in the assistants and residents with

home residents with patients with  Setting: Two skilled-care NASCP treatment condition relative to severe cognitive impairment and

dementia‖ dementia. nursing facilities (N=1 those in the control group. behavioral problems due to

 If participation of 96-bed, not for profit,  When staff in the control group subsequently dementia.

Gerontologist nursing assistants in voluntary facility; N=1 received NACSP training, reevaluation of

the NASCP results in 396-bed, public county the patient cohort indicated a significant NACSP training resulted in the

1999;39(5):546-58. greater knowledge of facility). decrease in symptoms of depression improvement in well-being of

dementia,  Study population: supporting the positive outcomes on nursing home residents with

knowledge of  N = 88 nursing assistants NACSP on CSDD. dementia, while not impacting

caregiver responses, (N=83 female).  Significant improvement in the physically on the continued decline in

and lower staff  N=105 residents (N=92 nonaggressive (from baseline to 3 months cognitive status of residents.

turnover rates. female). only) and verbally aggressive (at 3 and 6

 Intervention: NACSP – months) subscales of the CMAI for patients Non-sustained improvement in

NACSP is a skills 5x45 minute group in the treatment group relative to the certain subscales of the CMAI

training program sessions, 4x30 minute control group and subsequently in the may indicate a need for regular

designed to address individual conferences. control group relative to baseline when staff booster training sessions.

four areas: knowledge Comparison to control training implemented.

of dementia, verbal and group at baseline, three  NACSP training not effective in reducing Participation in NACSP training

nonverbal and six months. restraint usage with increase in physical may have a positive impact on

communication,  Evaluation: MMSE, restraint usage in both cohorts after staff turnover levels with

memory aids, and Cornell Scale for intervention. A reduction in psychotropic consequences for quality of care

problem behaviors. Depression in Dementia usage documented in the treatment group of dementia patients in nursing

(CSDD), but this did not persist. homes.

Multidimensional  Conflicting results on the MOSES.

Observation Scale for  NACSP training did not result in increased

Elderly Subjects knowledge of dementia among nursing

(MOSES), Cohen- assistants but did result in greater

Mansfield Agitation knowledge of caregiving responses and

Inventory (CMAI) scale. reduced staff turnover rates.

Table 2: Detailed Description of Empirical Studies on Non-Drug Behavioral Interventions in the Cognitively

Impaired





# Article Objectives Study Design Main Findings Discussion

Borson S et al. To examine:  Mail survey.  Perceived behavioral expertise of staff This survey of nursing directors

68  The perception of  Setting: All Medicare- varied as a function of discipline (p100 reporting little-to-no experience among most direct patient contact, and

 Nursing Director beds) = 64%. medical directors and 33% reporting nonpsychiatrist physicians who

perceptions of the  Under-representation of experience deficits among other attending prescribe the majority of

need for midwestern homes. physicians. psychotropic drug therapy in

improvements in  The need for skill training was highlighted by nursing homes.

competence. the majority of respondents with a ―good

deal / a lot‖ of improvement required by: The authors propose the need

 Aides: 72%. for a nursing home

 Physicians: 68-72%. interdisciplinary team training to

 Nurses: 67%. improve competence and further

 Other staff: 61%. collaborative care.

 85 years: 42%. residents with 4 limitations (4) in physical The authors conclude that the

 Patients with a diagnosis functioning. Depression was also presence of aggression may be

of dementia on significantly associated (p 60 years difficulty relating to data

with a diagnosis of collection.

severe dementia and

exhibiting frequent The authors advocate the need

noisemaking. for further research in

 Intervention: Positive determining the roles of social

reinforcement of quiet isolation and sensory

behavior and ignoring of deprivation on the etiology of

noisemaking, distraction noisemaking.

of patients and provision

of extra stimulation

(e.g., olfactory, tactile).

 Time frame of

intervention: 5-9 days

baseline assessment, 4-

day intervention period.

 Patients evaluated for

noisemaking,

(Behavioral Assessment

Graphical System

(BAGS)) and functional

ability (Rapid Disability

Rating Scale-2 (RDRS-

2)).

Table 2: Detailed Description of Empirical Studies on Non-Drug Behavioral Interventions in the Cognitively

Impaired





# Article Objectives Study Design Main Findings Discussion

Cohen-Mansfield J, To assess:  Prospective 2-week,  32/60 participants completed all The authors hypothesize that

77 Werner P  The effectiveness of controlled study. interventions. VDB is a result of social and

different  Setting: Nursing home.  Mean BCRS score: 5.5 ± 0.23. stimulus deprivation in the

―Management of interventions on  Study population:  97% had a diagnosis of dementia. nursing home environment.

verbally disruptive vocally disruptive  Size: N=60 (N=26  No identification of contributing physiological

behaviors in nursing behavior (VDB), female). sources of pain on medical examination. This study demonstrated

home residents‖ specifically the  Mean age: 86.8 ± 1.1  Clinical and statistically significant effect of significant clinical and statistical

impact of: years. environment interventions on VDB reductions in VDB with the use

Journal of Gerontology:  A medical  Residents exhibiting VDB compared to no-intervention with of stimulating activities. The

Medical Sciences examination aimed as identified by nursing reductions in VDB of: impact of the intervention was

at diagnosis and staff.  Social Interaction: 56%. limited to the duration of the

1997;52A(6):M369-77. treating any  Intervention: Baseline  Videotape: 46%. intervention. Interventions

underlying medical examination,  Music: 31%. involving interactions (social or

physiological exposure to music, to a  No-intervention: 16%. video) were most effective,

reason for VDB. family generated  Interventions involving interactions (social however the reduced

 Music on VDB. videotape and one-on- interaction or video) were most effective. effectiveness of music therapy

 A family-generated one social interaction  Lower effectiveness of music therapy than may have been related to lack

videotape. each for a 2-week for either of the other two interventions of individualization of the music.

 One-to-one social period followed by a although still better than no treatment.

interaction. wash-out week. The authors highlight the

 Effectiveness of the intervention limited to

 VDB was assessed using importance of medical

the duration of the intervention with

tape recordings, evaluation to rule out potential

immediate resumption of VDB on

standardized physical triggers for VDB

discontinuation.

observations despite the lack of impact of

 Patients with VDB tend to be frail, cognitively

(Screaming Mapping medical intervention in this

impaired.

Behavior Instrument cohort.

 Reduction of VDB Significant effect of one-

(SBMI)) and informant on-one social contact on VDB noted,

ratings (selected items particularly requests that involved request

on the CMAI). for attention and repeated words.

 Cognitive functioning

assessed using the Brief

Cognitive Rating Scale

(BCRS).

 Intervention effectiveness

assessed based on

frequency, duration and

nurse assessment of

VDB.