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

Active, not recruiting

• Conditions: Diabetes
• Interventions: Drug: Semaglutide; Drug: DPP-4 inhibitor

• Registration Number: NCT05768945
• Lead Sponsor: Brigham and Women's Hospital

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.

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 Timeline

• Study Start: 2022-11-30
• Study First Submitted: 2023-03-03
• Study First Submitted QC: 2023-03-03
• Study First Posted: 2023-03-15
• Status Verified: 2023-07
• Primary Completion: 2023-07-07
• Last Update Submitted: 2023-07-17
• Last Update Posted: 2023-07-19
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 742670

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Semaglutide	Semaglutide	Exposure group
DPP4 inhibitors (sitagliptin, saxagliptin, linagliptin, and alogliptin)	DPP-4 inhibitor	Reference group

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States