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Clinical trial

Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM)- Semaglutide v DPP4 Inhibitors

ID
Name
2019P003607-14
Description
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.
Trial arms
Trial start
2022-11-30
Estimated PCD
2023-07-07
Trial end
2023-12-31
Status
Active (not recruiting)
Treatment
Semaglutide
Semaglutide claim is used as the exposure group.
Arms:
Semaglutide
DPP-4 inhibitor
DPP4 inhibitors (sitagliptin, saxagliptin, linagliptin, and alogliptin) claim is used as the reference group.
Arms:
DPP4 inhibitors (sitagliptin, saxagliptin, linagliptin, and alogliptin)
Size
742670
Primary endpoint
Time to dementia onset
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
Eligibility criteria
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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 742670, 'type': 'ACTUAL'}}
Updated at
2023-07-19

1 organization

2 products

1 indication

Organization
Brigham and Women's Hospital
Product
Semaglutide
Indication
Diabetes
Product
DPP-4 inhibitor