Comparative Research of Alzheimer's Disease Drug (COMET-AD)
Comparative Research of Alzheimer's Disease Drug (COMET-AD)
Overall Status:
Recruiting
Brief Description:
This study will compare the effectiveness of approved medications for treating Alzheimer's disease in participants from real-world memory care clinics in Indiana.
Patient Qualifications:
| Min Age | Max Age | Gender | Healthy Volunteers |
|---|---|---|---|
65 Years | N/A | Both | No |
Inclusion Criteria:
- Diagnosis of possible or probable Alzheimer's disease
- Planning to initiate treatment with a cholinesterase inhibitor (donepezil, galantamine, or rivastigmine)
- Planning to continue care at one of the study sites
- Family caregiver willing to complete study outcome assessments
- Access to a telephone
- Ability to understand English-language survey instruments
Exclusion Criteria:
- Prior serious adverse event from the study medications
Detailed Description:
The goal of this study is to improve the nation's capacity to conduct comparative effectiveness research (CER), which compares the benefits and harms of different interventions and strategies to prevent, diagnose, treat, and monitor health conditions in real-world settings. The Regenstrief Institute will collaborate with Indiana University's Center for Aging Research and Division of Clinical Pharmacology to compare the effectiveness of approved medications for treating Alzheimer's disease in participants from five memory care clinics in central Indiana. These drugs are donepezil, galantamine, and rivastigmine. Investigators will analyze treatment patterns and patients' clinical outcomes.
Locations:
| Map Marker | City | State | Zip Code | Status | Primary Contact | |
|---|---|---|---|---|---|---|
Geolocation is 39.9616798, -85.9406745 | Touchpoint | Fishers | Indiana | 46037 | Not yet recruiting | |
Geolocation is 39.7794767, -86.1700894 | Wishard Health Services | Indianapolis | Indiana | 46202 | Recruiting | Malaz Boustani 317-423-5600 |
Geolocation is 39.8878841, -86.1853474 | St. Vincent Center for Healthy Aging | Indianapolis | Indiana | 46260 | Not yet recruiting | |
Geolocation is 39.7794767, -86.1700894 | Methodist Center for Geriatric Medicine | Indianapolis | Indiana | 46202 | Recruiting | |
Geolocation is 39.7794767, -86.1700894 | University Clinical Neurology | Indianapolis | Indiana | 46202 | Recruiting |
Lead Sponsor:
| Agency |
|---|
Regenstrief Institute, Indiana University Center for Aging Research |
Collaborator Sponsor:
| Agency |
|---|
Agency for Healthcare Research and Quality (AHRQ) |
Facility Investigators:
| Name | Role | Affiliation |
|---|---|---|
Malaz Boustani, MD, MPH | Principal Investigator | Regenstrief Institute, Indiana University Center for Aging Research |
Study Contact:
| Name | Phone | |
|---|---|---|
Amie Frame, MPH | 317-423-5910 |
Locations
ClinicalTrials.gov ID
NCT01362686 (follow link to view full record on ct.gov in new window)
Official Title:
Comparative Effectiveness Research Trial of Alzheimer's Disease Drug
Study Start Date:
April 2011
Study End Date:
September 2013
Disease Stage:
Early
Middle
Enrollment:
300
Trial References:
