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

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a non-randomized, non-interventional study that is part of the DREAM Study of Brigham and Women's Hospital. DREAM is led by Dr. Madhav Thambisetty, MD, PhD, Chief of the Clinical and Translational Neuroscience Section, Laboratory of Behavioral Neuroscience, National Institute on Aging (NIA) intramural research program. 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 using healthcare claims data.

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

Conditions
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Diabetes

Intervention / Treatment
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* Drug: Semaglutide
* Drug: DPP-4 inhibitor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Semaglutide<br>Exposure group | Drug: Semaglutide<br>* Semaglutide claim is used as the exposure group.<br>|
| DPP4 inhibitors (sitagliptin, saxagliptin, linagliptin, and alogliptin)<br>Reference group | Drug: DPP-4 inhibitor<br>* DPP4 inhibitors (sitagliptin, saxagliptin, linagliptin, and alogliptin) claim is used as the reference group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |