Study Stopped
Low study accrual caused the study to be ended early.
Comparative Research of Alzheimer's Disease Drugs
COMET-AD
Comparative Effectiveness Research Trial of Alzheimer's Disease Drugs
1 other identifier
interventional
200
1 country
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2011
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 26, 2011
CompletedFirst Posted
Study publicly available on registry
May 30, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedResults Posted
Study results publicly available
February 27, 2017
CompletedFebruary 27, 2017
January 1, 2017
4.5 years
May 26, 2011
July 22, 2016
January 8, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Discontinuation Rates
We are not seeking to establish efficacy of these three medications for the indication of Alzheimer's disease. Each of these medications already has FDA-approval for Alzheimer's. The primary outcome measure is the discontinuation rate among the three medications. Based on previous systematic reviews, these rates are reportedly in the range of 30% by 12 weeks compared with placebo. We will determine the approximate date of discontinuation by self-reports from the caregiver through the telephone-based interview at 6, 12, and 18 weeks.
6, 12, and 18 week interviews from enrollment
Secondary Outcomes (2)
Neuropsychiatric Inventory (NPI)
Baseline, 6, 12, 18 week interviews from enrollment
Healthy Aging Brain Care (HABC)-Monitor
baseline, 6, 12, and 18 week interviews
Study Arms (3)
Donepezil
EXPERIMENTALSee intervention note.
Galantamine
EXPERIMENTALSee intervention note.
Rivastigmine
EXPERIMENTALSee intervention note.
Interventions
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. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care.
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. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care.
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. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care.
Eligibility Criteria
You may qualify if:
- 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-Language survey instruments
You may not qualify if:
- prior serious adverse event from the study medications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Touchpoint
Fishers, Indiana, 46037, United States
Methodist Center for Geriatric Medicine
Indianapolis, Indiana, 46202, United States
University Clinical Neurology
Indianapolis, Indiana, 46202, United States
Wishard Health Services
Indianapolis, Indiana, 46202, United States
St. Vincent Center for Healthy Aging
Indianapolis, Indiana, 46260, United States
Related Publications (7)
Callahan CM, Boustani MA, Unverzagt FW, Austrom MG, Damush TM, Perkins AJ, Fultz BA, Hui SL, Counsell SR, Hendrie HC. Effectiveness of collaborative care for older adults with Alzheimer disease in primary care: a randomized controlled trial. JAMA. 2006 May 10;295(18):2148-57. doi: 10.1001/jama.295.18.2148.
PMID: 16684985BACKGROUNDBoustani M, Callahan CM, Unverzagt FW, Austrom MG, Perkins AJ, Fultz BA, Hui SL, Hendrie HC. Implementing a screening and diagnosis program for dementia in primary care. J Gen Intern Med. 2005 Jul;20(7):572-7. doi: 10.1111/j.1525-1497.2005.0126.x.
PMID: 16050849BACKGROUNDBoustani MA, Frame A, Munger S, Healey P, Westlund J, Farlow M, Hake A, Austrom MG, Shepard P, Bubp C, Azar J, Nazir A, Adams N, Campbell NL, Chehresa A, Dexter P. Connecting research discovery with care delivery in dementia: the development of the Indianapolis Discovery Network for Dementia. Clin Interv Aging. 2012;7:509-16. doi: 10.2147/CIA.S36078. Epub 2012 Nov 16.
PMID: 23204843BACKGROUNDCampbell N, Boustani M, Limbil T, Ott C, Fox C, Maidment I, Schubert CC, Munger S, Fick D, Miller D, Gulati R. The cognitive impact of anticholinergics: a clinical review. Clin Interv Aging. 2009;4:225-33. doi: 10.2147/cia.s5358. Epub 2009 Jun 9.
PMID: 19554093BACKGROUNDLim AWY, Schneider L, Loy C. Galantamine for dementia due to Alzheimer's disease and mild cognitive impairment. Cochrane Database Syst Rev. 2024 Nov 5;11(11):CD001747. doi: 10.1002/14651858.CD001747.pub4.
PMID: 39498781DERIVEDCampbell NL, Perkins AJ, Gao S, Skaar TC, Li L, Hendrie HC, Fowler N, Callahan CM, Boustani MA. Adherence and Tolerability of Alzheimer's Disease Medications: A Pragmatic Randomized Trial. J Am Geriatr Soc. 2017 Jul;65(7):1497-1504. doi: 10.1111/jgs.14827. Epub 2017 Mar 14.
PMID: 28295141DERIVEDCampbell NL, Dexter P, Perkins AJ, Gao S, Li L, Skaar TC, Frame A, Hendrie HC, Callahan CM, Boustani MA. Medication adherence and tolerability of Alzheimer's disease medications: study protocol for a randomized controlled trial. Trials. 2013 May 4;14:125. doi: 10.1186/1745-6215-14-125.
PMID: 23782591DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Small sample size limits generalizability and may introduce type II error. The study took place at a time when most third-party payers declared donepezil the preferred AChEI due to cost that may have influenced study's results.
Results Point of Contact
- Title
- Dr. Noll Campbell
- Organization
- Regenstrief Insitute
Study Officials
- PRINCIPAL INVESTIGATOR
Malaz Boustani, MD, MPH
Regenstrief Institute, Center for Aging Research
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Regenstrief Institute, IU Center for Aging Reserach Scientist
Study Record Dates
First Submitted
May 26, 2011
First Posted
May 30, 2011
Study Start
April 1, 2011
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
February 27, 2017
Results First Posted
February 27, 2017
Record last verified: 2017-01