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

Sponsor

Brigham and Women's Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05125224

Collaborator

National Institute on Aging (NIA) (NIH), Rutgers University (Other), Johns Hopkins University (Other)

163,720

Enrollment

Location

Anticipated Duration (Months)

10253.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: Dihydropyridine calcium channel blocker Drug: Hydrochlorothiazide

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

163720 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Oct 1, 2021

Actual Primary Completion Date :

Dec 9, 2021

Anticipated Study Completion Date :

Jan 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Dihydropyridine calcium channel blocker Exposure group	Drug: Dihydropyridine calcium channel blocker Dihydropyridine calcium channel blocker claim is used as the exposure group.
Hydrochlorothiazide Reference group	Drug: Hydrochlorothiazide Hydrochlorothiazide claim is used as the reference group.

Arm

Intervention/Treatment

Dihydropyridine calcium channel blocker

Exposure group

Drug: Dihydropyridine calcium channel blocker

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

Hydrochlorothiazide

Reference group

Drug: Hydrochlorothiazide

Hydrochlorothiazide claim is used as the reference group.

Outcome Measures

Primary Outcome Measures

Time to dementia onset [Through study completion (a median of 238 days)]
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.

Secondary Outcome Measures

Time to Alzheimer's disease onset [Through study completion (a median of 238 days)]
Time to Alzheimer's disease onset. Please refer to uploaded protocol for full definition due to size limitations.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Please see https://docs.google.com/spreadsheets/d/1VlyY3zcxoRp0tH7yv8rSOEggSO6WQ0VYEjq-6KlSSt8/edit?us p=sharing or Appendix A for full code and algorithm definitions.

Medicare timeframe: 2008 to 2018 (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. 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
1. Prior use of dihydropyridine CCBs, hydrochlorothiazide, or other antihypertensives anytime prior to cohort entry date