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Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM)- Dihydropyridine Calcium Channel Blockers Versus Hydrochlorothiazide

NCT ID: NCT05125224

Last Updated: 2025-11-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

163720 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-01

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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Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Dihydropyridine calcium channel blocker

Exposure group

Dihydropyridine calcium channel blocker

Intervention Type DRUG

Dihydropyridine calcium channel blocker claim is used as the exposure group.

Hydrochlorothiazide

Reference group

Hydrochlorothiazide

Intervention Type DRUG

Hydrochlorothiazide claim is used as the reference group.

Interventions

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Dihydropyridine calcium channel blocker

Dihydropyridine calcium channel blocker claim is used as the exposure group.

Intervention Type DRUG

Hydrochlorothiazide

Hydrochlorothiazide 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\. For Medicare - Enrollment in Medicare Part A, B, and D with no HMO coverage for 365 days prior to and including cohort entry date
* 3\. At least two claims with hypertension diagnosis recorded in 365 days prior to cohort entry date

Exclusion Criteria

* 1\. Prior history of dementia measured anytime prior to cohort entry date
* 2\. Prior use of dihydropyridine CCBs, hydrochlorothiazide, or other antihypertensives anytime prior to cohort entry date
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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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2019A010961-6

Identifier Type: -

Identifier Source: org_study_id