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

NCT ID: NCT05768945

Last Updated: 2025-11-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

742670 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-30

Study Completion Date

2023-12-31

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.

Conditions

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Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Semaglutide

Exposure group

Semaglutide

Intervention Type DRUG

Semaglutide claim is used as the exposure group.

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

Reference group

DPP-4 inhibitor

Intervention Type DRUG

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

Interventions

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Semaglutide

Semaglutide claim is used as the exposure group.

Intervention Type DRUG

DPP-4 inhibitor

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Rutgers University

OTHER

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Rishi J. Desai

Assistant Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Madhav Thambisetty, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Institute on Aging (NIA)

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2019P003607-14

Identifier Type: -

Identifier Source: org_study_id