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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:
ClinicalTrials.gov Identifier:
NCT01362686
First Posted: May 30, 2011
Last Update Posted: February 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Malaz Boustani, MD, MPH, Regenstrief Institute, Inc.
May 26, 2011
May 30, 2011
July 22, 2016
February 27, 2017
February 27, 2017
April 2011
October 2015   (Final data collection date for primary outcome measure)
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.
Discontinuation and Adherence 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.
Complete list of historical versions of study NCT01362686 on ClinicalTrials.gov Archive Site
  • 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.
  • Neuropsychiatric Inventory (NPI) [ Time Frame: 6, 12, 18 week interviews from enrollment ]
    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 ]
    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.
Not Provided
Not Provided
 
Comparative Research of Alzheimer's Disease Drugs
Comparative Effectiveness Research Trial of Alzheimer's Disease Drugs
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.

The overarching goal of this proposal is to enhance the existing information technology infrastructure in Central Indiana to improve the nation's capacity to conduct comparative effectiveness research (CER). Consistent with the instructions in RFA-HS-10-005, the investigators propose to apply these new capacities to a novel CER project evaluating treatment for Alzheimer's disease. Alzheimer's disease has been identified as a first quartile CER priority. This proposal represents collaboration between the Medical Informatics Program at the Regenstrief Institute, Inc (a world leader in health information technology) and two Indiana University research programs: the Center for Aging Research and the Division of Clinical Pharmacology. These programs have an established track record in research relevant to under-served populations. Thus, this proposal combines considerable investigator, environment, and research strengths to continue to build a novel CER infrastructure in support of the nation's evidentiary CER priorities.

Throughout this proposal, the investigators use the AHRQ definition of CER: the conduct and synthesis of research comparing the benefits and harms of different interventions and strategies to prevent, diagnose, treat and monitor health conditions in real world settings." The investigators also refer to a clinical trial of medication treatment for behavioral symptoms of Alzheimer's disease as the specific CER proposed to demonstrate the potential of our new infrastructure. However, the investigators stress that the enhancements proposed to existing infrastructure would support a broad portfolio of CER across an array of priority conditions. The investigators are also proposing enhancements in our privacy and confidentiality technology that would allow researchers from across the country to access de-identified data in support of CER. In summary, the investigators are proposing to add new CER knowledge on Alzheimer' disease and thereby field test new information technology capacities important to a wide range of CER projects while also increasing our capacity to provide data and opportunities for nationwide CER.

The derivation of meaningful and actionable evidence from CER ultimately depends on capturing relevant, comprehensive and accurate data about treatment decisions, patients' clinical status, their care processes and environment, and the health outcomes they experience and value. Such data must be tracked longitudinally in order to determine temporal relationships, cause-effect paradigms, and the efficacy of specific clinical interventions in the context of other conditions, interventions, and goals of care. At Indiana University and the Regenstrief Institute, the investigators have four decades of experience and a well-documented, world-class clinical informatics and research infrastructure for capturing, storing, querying and analyzing treatment patterns and patients' clinical outcomes.

The maturation of this health information technology is now embodied within the Indiana Network for Patient Care (INPC), a fully-operational regional health information exchange. The investigators are well positioned to expand and leverage this infrastructure in support of local and national multi-site clinical trials in comparative effectiveness. The specific aims of this proposal are to:

1.0 PROSPECT STUDY: Enhance our existing information technology infrastructure to:

  1. provide de-identified access to the INPC database for CER work
  2. capture, store, and track a broader array of health care outcomes important to patients and their caregivers (e.g. behavioral symptoms due to dementia);
  3. support providers' and caregivers' and researchers' increasing need to work in teams by providing new tools for communication and co-management (e.g. collaborative care and research)

2.0 COMET-AD STUDY: Conduct 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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Dementia
  • Alzheimer's Disease
  • 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
  • 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
  • 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
  • Experimental: Donepezil
    See intervention note.
    Intervention: Drug: Donepezil
  • Experimental: Galantamine
    See intervention note.
    Intervention: Drug: Galantamine
  • Experimental: Rivastigmine
    See intervention note.
    Intervention: Drug: Rivastigmine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
200
October 2015
October 2015   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
65 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01362686
R01HS019818-01( U.S. AHRQ Grant/Contract )
R01HS019818-01 ( U.S. AHRQ Grant/Contract )
Yes
Not Provided
Not Provided
Malaz Boustani, MD, MPH, Regenstrief Institute, Inc.
Indiana University
Agency for Healthcare Research and Quality (AHRQ)
Principal Investigator: Malaz Boustani, MD, MPH Regenstrief Institute, Center for Aging Research
Indiana University
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP