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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.
Results First Submitted: July 22, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Dementia
Alzheimer's Disease
Interventions: Drug: Donepezil
Drug: Galantamine
Drug: Rivastigmine

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment took place from 2011-2014. Recruitment took place in geriatric and memory care specialty clinics in an urban setting. Registered nurses, nurse practitioners, and research assistants completed the recruitment and informed consent procedures.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The enrollment goal in the original protocol of the study was 200 patient-caregiver dyads. 200 were enrolled, but it was discovered that 4 dyads were ineligible after enrollment and were not randomized or included in the study which brings the total enrollment to 196. Recruitment was then terminated due to low enrollment rate.

Reporting Groups
  Description
Donepezil

See intervention note.

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.

Galantamine

See intervention note.

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.

Rivastigmine

See intervention note.

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.


Participant Flow:   Overall Study
    Donepezil   Galantamine   Rivastigmine
STARTED   67   66   63 
COMPLETED   59   54   53 
NOT COMPLETED   8   12   10 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Donepezil

See intervention note.

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.

Galantamine

See intervention note.

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.

Rivastigmine

See intervention note.

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.

Total Total of all reporting groups

Baseline Measures
   Donepezil   Galantamine   Rivastigmine   Total 
Overall Participants Analyzed 
[Units: Participants]
 67   66   63   196 
Age 
[Units: Years]
Mean (Standard Deviation)
 79.1  (7.6)   80.1  (9.6)   81.6  (7.8)   80.2  (8.4) 
Gender 
[Units: Participants]
Count of Participants
       
Female      19  28.4%      20  30.3%      12  19.0%      51  26.0% 
Male      48  71.6%      46  69.7%      51  81.0%      145  74.0% 


  Outcome Measures
  Show All Outcome Measures

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

2.  Secondary:   Neuropsychiatric Inventory (NPI)   [ Time Frame: Baseline, 6, 12, 18 week interviews from enrollment ]

3.  Secondary:   Healthy Aging Brain Care (HABC)-Monitor   [ Time Frame: baseline, 6, 12, and 18 week interviews ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Noll Campbell
Organization: Regenstrief Insitute
phone: 317-274-9051
e-mail: cambenl@regenstrief.org


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Malaz Boustani, MD, MPH, Regenstrief Institute, Inc.
ClinicalTrials.gov Identifier: NCT01362686     History of Changes
Other Study ID Numbers: R01HS019818-01 ( U.S. AHRQ Grant/Contract )
First Submitted: May 26, 2011
First Posted: May 30, 2011
Results First Submitted: July 22, 2016
Results First Posted: February 27, 2017
Last Update Posted: February 27, 2017