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Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM)- Propranolol/Carvedilol Versus Atenolol/Bisoprolol/Sotalol

NCT ID: NCT05794997

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

817337 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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Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Propranolol or Carvedilol

Exposure group

Propranolol or Carvedilol

Intervention Type DRUG

Propranolol or Carvedilol claim is used as the exposure group.

Atenolol, Bisoprolol or Sotalol

Reference group

Atenolol, Bisoprolol or Sotalol

Intervention Type DRUG

Atenolol, Bisoprolol or Sotalol claim is used as the reference group.

Interventions

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Propranolol or Carvedilol

Propranolol or Carvedilol claim is used as the exposure group.

Intervention Type DRUG

Atenolol, Bisoprolol or Sotalol

Atenolol, Bisoprolol or Sotalol 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\. At least 1 inpatient claim or 2 outpatient claims with hypertension diagnosis recorded in 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 Propranolol, Carvedilol and Atenolol, Bisoprolol, Sotalol
* 4\. Use of Propranolol, Carvedilol and Atenolol, Bisoprolol, Sotalol 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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2019P003607-13

Identifier Type: -

Identifier Source: org_study_id