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

NCT05125224 | Completed Results FDA Drug

• 1 other identifier: 2019A010961-6
• Study Type: observational
• Target: 163,720
• 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

Hypertension

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) 189 days (exp), 171 days (ref) 2) 835 days (exp). 851 days (ref) 3) 388 days (exp), 348 days (ref) 4) 191 days (exp), 172 days (ref)

Study Arms (2)

Dihydropyridine calcium channel blocker

Exposure group

Drug: Dihydropyridine calcium channel blocker

Hydrochlorothiazide

Reference group

Drug: Hydrochlorothiazide

Interventions

Dihydropyridine calcium channel blocker DRUG

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

Dihydropyridine calcium channel blocker

Hydrochlorothiazide DRUG

Hydrochlorothiazide claim is used as the reference group.

Hydrochlorothiazide

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• 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 dihydropyridine CCBs to hydrochlorothiazide. The patients will be required to have continuous enrollment during the baseline period of 365 days before initiation of dihydropyridine CCBs or hydrochlorothiazide (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
• \. For Medicare - Enrollment in Medicare Part A, B, and D with no HMO coverage for 365 days prior to and including cohort entry date
• \. At least two claims with hypertension diagnosis recorded in 365 days prior to cohort entry date

You may not qualify if:

• \. Prior history of dementia measured anytime prior to cohort entry date
• \. Prior use of dihydropyridine CCBs, hydrochlorothiazide, or other antihypertensives anytime prior to cohort entry 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, 02120, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

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
• Restriction Type: OTHER
• 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: November 8, 2021
• First Posted: November 18, 2021
• Study Start: October 1, 2021
• Primary Completion: July 7, 2023
• Study Completion: December 31, 2023
• Last Updated: November 6, 2025
• Results First Posted: November 6, 2025

Record last verified: 2025-10

Locations

US (1)