COMET-AD - IDND

							Indianapolis Discovery Network
for Dementia



 Comparative Effectiveness Research Trial of
   Alzheimer’s Disease Drug: COMET-AD
                  Malaz Boustani, MD, MPH
           Network Director, Indianapolis Discovery
                    Network for Dementia
    Assistant Professor of Medicine, IU School of Medicine
         Research Scientist, Regenstrief Institute, Inc



                     www.indydiscoverynetwork.org
                                  Goals

•   Conduct a comparative effectiveness clinical trial of medication treatment
    for behavioral symptoms of Alzheimer’s disease in a group of real-world
    memory care clinics with enhanced access to the Indiana Network for
    Patient Care.

•   Add new comparative effectiveness research (CER) knowledge on
    Alzheimer’s disease to our existing information technology infrastructure.

•   Field test new information technology capacities (PROSPECT study).




                             www.indydiscoverynetwork.org
                           COMET-AD
•   Patients participating in the study will be randomized to treatment with
    donepezil, rivastigmine, or galantamine; no patients will be allocated to a
    placebo.

•   The study is open-label and the memory care practice physicians will make
    determinations about initial drug dosage and any dosage changes and the
    timing of those changes.

•   Each of these medications already has FDA-approval for Alzheimer’s. The
    primary outcome measure is the discontinuation rate among the three
    medications.




                              www.indydiscoverynetwork.org
                                    Recruitment
•   Recruitment completed by designated memory care practice staff member:
     –   The nurse, research assistant, or other designated staff member in each memory care
         practice will
           •   Identify eligible patients and their caregivers
           •   Discuss study
           •   Obtain informed consent from the patient and/or an informal caregiver
           •   Patient blood draw


•   Surveys completed by Research Assistant (RA):
     –   Telephone interview to administer study instruments


•   Physician Involvement:
     –   Amount of involvement based on own preferences and availability
     –   Possible activities: inform patients of study, receive screening/diagnostic results
     –   Minimal impact on day to day operations




                                         www.indydiscoverynetwork.org
Inclusion/Exclusion Criteria

Inclusion criteria include:
•   older adults with a diagnosis of possible or probable Alzheimer’s disease
•   planning to initiate treatment with a cholinesterase inhibitor
•   planning to continue care in the memory care practice
•   participation by a family caregiver willing to complete the study outcome
    assessments
•   access to a telephone
•   ability to understand English


Exclusion criteria include:
•   prior serious adverse event from the study medications




                            www.indydiscoverynetwork.org
    Recruitment Procedure
•   The proposed CER study will be conducted in five memory care practices
    representing the four health care systems affiliated with Indianapolis Discovery
    Network for Dementia (IDND)
     –   Wishard, Clarian, St. Vincent, and Community Health Network


•   The nurse will approach eligible patients and request consent for study. Upon
    enrollment, the nurse will draw the patient’s blood at the beginning of the study and at
    the patient’s next office visit. A little over 2 teaspoons of blood will be drawn on each
    occasion, for a total of 20mL (or a little over 4 teaspoons) of blood.


•   A research assistant, blinded to the subject’s allocation, will call the patient
    and their caregiver to administer three different instruments:
           1. The medication survey (caregiver only)
           2. Neuropsychiatric Inventory (NPI) (caregiver only)
           3. HABC Monitor for the patient and/or caregiver




                                   www.indydiscoverynetwork.org
 Recruitment Procedure

• The RA will call the patient and the caregiver to re-administer the
  three instruments again at 6, 12, and 18 weeks into the study.

• Each telephone interview takes approximately 45 minutes to
  complete.

• The patient and caregiver dyad will receive a $75 gift card at the
  completion of the study




                         www.indydiscoverynetwork.org
Recruitment Flow Chart
                                 Older adult diagnosed with probable
                                 Alzheimer’s disease at a participating
                                        Memory Care Practice
                                                N=500

                                                                         Excluded due to:
                                                                   Inclusion / exclusion criteria
                                                                              Refusal
                                                                               Other

                                   Consent and Baseline assessment
                                               N=300


                                       Randomization by Patient
                                  Stratified by Memory Care Practice


     Allocated to donepezil            Allocated to rivastigmine          Allocated to galantamine
             N=100                              N=100                              N=100



                              Follow-up assessment at 6, 12, and 18 weeks




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