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

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Mass General Brigham

Status

Active, not recruiting

Conditions

Diabetes

Treatments

Drug: DPP-4 inhibitor
Drug: Semaglutide

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT05768945
2019P003607-14

Details and patient eligibility

About

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.

Full 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.

Enrollment

742,670 patients

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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
    1. Enrollment in Medicare Part A, B, and D with no HMO coverage for 365 days prior to and including cohort entry date
    1. 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
    1. Prior history of nursing home admission in the 365 days prior to the cohort entry date
    1. Prior use of any GLP receptor agonists (semaglutide, exenatide, liraglutide, albiglutide, dulaglutide, lixisenatide) or DPP4 inhibitors
    1. Prior use of Semaglutide or DPP4 inhibitors concomitantly on index date

Trial design

742,670 participants in 2 patient groups

Semaglutide
Description:
Exposure group
Treatment:
Drug: Semaglutide
DPP4 inhibitors (sitagliptin, saxagliptin, linagliptin, and alogliptin)
Description:
Reference group
Treatment:
Drug: DPP-4 inhibitor

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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