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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: April 11, 2016
Last verified: April 2016
  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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group 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 and Adherence Rates [ Time Frame: 6, 12, and 18 week interviews from enrollment ] [ Designated as safety issue: No ]
    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: 6, 12, 18 week interviews from enrollment ] [ Designated as safety issue: No ]
    The NPI has been adopted by the Alzheimer's Disease Cooperative Studies (ADCS) 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. There are also follow-up questions to assess frequency, severity, and the level of caregiver distress due to the behavior. The administration time is about 20 minutes and will be administered to the caregiver by telephone.

  • HABC Monitor [ Time Frame: baseline, 6, 12, and 18 week interviews ] [ Designated as safety issue: No ]
    Its face validity was assessed based on feedback of an interdisciplinary team of 22 dementia care specialists. The panel selected 15 items captured from the AD8, the PHQ-9, and the NPI-Q to measure cognitive, behavioral and psychological symptoms of dementia. However, the panel also determined it necessary to develop 17 additional items to capture the functional, safety and caregiver burden aspects of dementia care. The HABC Monitor takes about 5 minutes to complete. The current HABC Monitor has two versions, a caregiver version and a self-report version.


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)
Genders Eligible for Study:   Both
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 
Study First Received: May 26, 2011
Last Updated: April 11, 2016
Health Authority: United States: Federal Government

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
Galantamine
Rivastigmine
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nootropic Agents
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on September 30, 2016