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

NCT05768945 | Completed Results FDA Drug

• 1 other identifier: 2019P003607-14
• Study Type: observational
• Target: 742,670
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• 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.

  Median follow up times: 1) 98 days (exp), 134 days (ref) 2) 118 days (exp), 132 days (ref) 3) 90 days (exp), 308 days (ref) 4) 99 days (exp), 135 days (ref)

Study Arms (2)

Semaglutide

Exposure group

Drug: Semaglutide

DPP4 inhibitors (sitagliptin, saxagliptin, linagliptin, and alogliptin)

Reference group

Drug: DPP-4 inhibitor

Interventions

Semaglutide DRUG

Semaglutide claim is used as the exposure group.

Semaglutide

DPP-4 inhibitor DRUG

DPP4 inhibitors (sitagliptin, saxagliptin, linagliptin, and alogliptin) claim is used as the reference group.

DPP4 inhibitors (sitagliptin, saxagliptin, linagliptin, and alogliptin)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will employ a new user, active comparator, observational cohort study design comparing semaglutide v DPP4 inhibitors (sitagliptin, saxagliptin, linagliptin, and alogliptin). The patients will be required to have continuous enrollment during the baseline period of 365 days before initiation of study drugs (index date). Follow-up for the outcome (dementia) differs between analyses. Follow-up begins the day after drug initiation (analysis 1, 3, 4); 180 days after drug initiation (analysis 2).

You may qualify if:

• \. Aged \>/= 65 years on the index date
• \. Enrollment in Medicare Part A, B, and D with no HMO coverage for 365 days prior to and including cohort entry date
• \. Diagnosis code for type 2 diabetes measured 365 days prior to drug initiation

You may not qualify if:

• \. Prior history of dementia measured anytime prior to cohort entry date
• \. Prior history of nursing home admission in the 365 days prior to the cohort entry date
• \. Prior use of any GLP receptor agonists (semaglutide, exenatide, liraglutide, albiglutide, dulaglutide, lixisenatide) or DPP4 inhibitors
• \. Prior use of Semaglutide or DPP4 inhibitors concomitantly on index date

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Institute on Aging (NIA): collaborator
• Rutgers University: collaborator
• Johns Hopkins University: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

semaglutide; Dipeptidyl-Peptidase IV Inhibitors

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Results Point of Contact

• Title: Rishi J Desai, PhD
• Organization: Brigham and Women's Hospital

rdesai@bwh.harvard.edu

617-278-0932

Study Officials

• Madhav Thambisetty, MD, PhD

  National Institute on Aging (NIA)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: March 15, 2023
• Study Start: November 30, 2022
• Primary Completion: July 7, 2023
• Study Completion: December 31, 2023
• Last Updated: November 10, 2025
• Results First Posted: November 10, 2025

Record last verified: 2025-10

Locations

US (1)