Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM)- Semaglutide v DPP4 Inhibitors
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Semaglutide Exposure group |
Drug: Semaglutide
Semaglutide claim is used as the exposure group.
|
| DPP4 inhibitors (sitagliptin, saxagliptin, linagliptin, and alogliptin) Reference group |
Drug: DPP-4 inhibitor
DPP4 inhibitors (sitagliptin, saxagliptin, linagliptin, and alogliptin) claim is used as the reference group.
|
Outcome Measures
Primary Outcome Measures
- 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]
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.
Secondary Outcome Measures
- Time to Alzheimer's disease onset [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]
Time to Alzheimer's disease onset. Please refer to uploaded protocol for full definition due to size limitations.
Eligibility Criteria
Criteria
Please see https://drive.google.com/drive/folders/1VRjPaaelXFyBbA5gV6pwB_ijSIMyIJ4N?usp=share_link or Appendix A for full code and algorithm definitions.
Medicare timeframe: 2008 to 2019 (end of data availability).
Inclusion Criteria:
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- Aged >/= 65 years on the index date
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- Enrollment in Medicare Part A, B, and D with no HMO coverage for 365 days prior to and including cohort entry date
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- Diagnosis code for type 2 diabetes measured 365 days prior to drug initiation
Exclusion Criteria:
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- Prior history of dementia measured anytime prior to cohort entry date
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- Prior history of nursing home admission in the 365 days prior to the cohort entry date
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- Prior use of any GLP receptor agonists (semaglutide, exenatide, liraglutide, albiglutide, dulaglutide, lixisenatide) or DPP4 inhibitors
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- Prior use of Semaglutide or DPP4 inhibitors concomitantly on index date
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Brigham and Women's Hospital | Boston | Massachusetts | United States | 02115 |
Sponsors and Collaborators
- Brigham and Women's Hospital
- National Institute on Aging (NIA)
- Rutgers University
- Johns Hopkins University
Investigators
- Principal Investigator: Madhav Thambisetty, MD, PhD, National Institute on Aging (NIA)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2019P003607-14