Diabetes Clinical Trial
Official title:
Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM)- Semaglutide v DPP4 Inhibitors
Verified date | July 2023 |
Source | Brigham and Women's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study aims to evaluate the comparative risk of dementia/Alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication.
Status | Active, not recruiting |
Enrollment | 742670 |
Est. completion date | December 31, 2023 |
Est. primary completion date | July 7, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 65 Years and older |
Eligibility | Please see https://drive.google.com/drive/folders/1VRjPaaelXFyBbA5gV6pwB_ijSIMyIJ4N?usp=share_link or Appendix A(https://drive.google.com/drive/folders/1OgKQlxsJi9UWRDd3Kbaux_8adngoSnZY?usp=sharing) for full code and algorithm definitions. Medicare timeframe: 2008 to 2019 (end of data availability). Inclusion Criteria: - 1. Aged >/= 65 years on the index date - 2. Enrollment in Medicare Part A, B, and D with no HMO coverage for 365 days prior to and including cohort entry date - 3. Diagnosis code for type 2 diabetes measured 365 days prior to drug initiation Exclusion Criteria: - 1. Prior history of dementia measured anytime prior to cohort entry date - 2. Prior history of nursing home admission in the 365 days prior to the cohort entry date - 3. Prior use of any GLP receptor agonists (semaglutide, exenatide, liraglutide, albiglutide, dulaglutide, lixisenatide) or DPP4 inhibitors - 4. Prior use of Semaglutide or DPP4 inhibitors concomitantly on index date |
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital | Johns Hopkins University, National Institute on Aging (NIA), Rutgers University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to dementia onset | Time to dementia onset, i.e., Alzheimer's disease, vascular dementia, senile, presenile, or unspecified dementia, or dementia in other diseases classified elsewhere. Please refer to uploaded protocol for full definition due to size limitations. | From date of drug initiation until the first of dementia onset, end of Medicare enrollment, or end of study period, whichever came first, assessed up to 6 years | |
Secondary | Time to Alzheimer's disease onset | Time to Alzheimer's disease onset. Please refer to uploaded protocol for full definition due to size limitations. | From date of drug initiation until the first of Alzheimer's disease onset, end of Medicare enrollment, or end of study period, whichever came first, assessed up to 6 years |
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