Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Comparative Research of Alzheimer's Disease Drugs (COMET-AD)

This study has been terminated.
(Low study accrual caused the study to be ended early.)
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Malaz Boustani, MD, MPH, Regenstrief Institute, Inc.
ClinicalTrials.gov Identifier:
NCT01362686
First received: May 26, 2011
Last updated: January 8, 2017
Last verified: January 2017
  Purpose
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.

Condition Intervention
Dementia
Alzheimer's Disease
Drug: Donepezil
Drug: Galantamine
Drug: Rivastigmine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparative Effectiveness Research Trial of Alzheimer's Disease Drugs

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Discontinuation Rates [ Time Frame: 6, 12, and 18 week interviews from enrollment ]
    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.


Secondary Outcome Measures:
  • Neuropsychiatric Inventory (NPI) [ Time Frame: Baseline, 6, 12, 18 week interviews from enrollment ]
    The NPI is based on a structured interview administered to an informal caregiver and has been adopted by the Alzheimer's Disease Cooperative Studies Group to obtain information on the presence of psychopathology in behavioral areas including delusions, apathy, hallucinations, disinhibition, agitation, depression, aberrant motor behavior, anxiety, night-time behavior, and euphoria.9 For each of 12 symptoms, if the caregiver reports the presence of psychopathology, a frequency and severity score are multiplied to yield a possible item score range of 0-12, and a possible total score range of 0-144. The NPI can be used to assess changes in the patient's behavior over the past month. The NPI also assesses the level of caregiver distress attributable to each of the 12 patient behaviors, with a possible total caregiver distress score range of 0-60. Higher scores indicate higher severity of psychopathology and caregiver disress. The NPI has excellent reliability and validity.

  • Healthy Aging Brain Care (HABC)-Monitor [ Time Frame: baseline, 6, 12, and 18 week interviews ]
    The current HABC-Monitor includes 30 items covering four clinically relevant domains of dementia, ie, cognitive, functional, behavioral, and psychological symptoms, and caregiver quality of life. For brevity and practical use in the clinical setting, each item on the four scales was designed to have the same item response options consisting of four categories that use the frequency of the target problem in the past 2 weeks. The HABC- Monitor took approximately 6 minutes to complete. The scores of the four scales are summed to create the total scores which were used in this analysis.The higher the total score, the higher the level of self reported caregiver burden. The minimum score is 0 and the maximum score is 90.


Enrollment: 200
Study Start Date: April 2011
Study Completion Date: October 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Donepezil
See intervention note.
Drug: Donepezil
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.
Other Name: Aricept
Experimental: Galantamine
See intervention note.
Drug: Galantamine
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.
Other Name: Razadyne
Experimental: Rivastigmine
See intervention note.
Drug: Rivastigmine
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.
Other Name: Exelon

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

• prior serious adverse event from the study medications

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01362686

Locations
United States, Indiana
Touchpoint
Fishers, Indiana, United States, 46037
Methodist Center for Geriatric Medicine
Indianapolis, Indiana, United States, 46202
University Clinical Neurology
Indianapolis, Indiana, United States, 46202
Wishard Health Services
Indianapolis, Indiana, United States, 46202
St. Vincent Center for Healthy Aging
Indianapolis, Indiana, United States, 46260
Sponsors and Collaborators
Indiana University
Agency for Healthcare Research and Quality (AHRQ)
Investigators
Principal Investigator: Malaz Boustani, MD, MPH Regenstrief Institute, Center for Aging Research
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Malaz Boustani, MD, MPH, Regenstrief Institute, IU Center for Aging Reserach Scientist, Regenstrief Institute, Inc.
ClinicalTrials.gov Identifier: NCT01362686     History of Changes
Other Study ID Numbers: R01HS019818-01 ( US NIH Grant/Contract Award Number )
Study First Received: May 26, 2011
Results First Received: July 22, 2016
Last Updated: January 8, 2017

Keywords provided by Indiana University:
diagnosis of Alzheimer's disease
medication adherence

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Rivastigmine
Galantamine
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nootropic Agents

ClinicalTrials.gov processed this record on May 23, 2017