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

NCT05794997 | Completed Results FDA Drug

• 1 other identifier: 2019P003607-13
• Study Type: observational
• Target: 817,337
• 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) 298 days (exp), 249 days (ref) 2) 995 days (exp), 981 days (ref) 3) 515 days (exp), 448 days (ref) 4) 307 days (exp), 253 days (ref)

Study Arms (2)

Propranolol or Carvedilol

Exposure group

Drug: Propranolol or Carvedilol

Atenolol, Bisoprolol or Sotalol

Reference group

Drug: Atenolol, Bisoprolol or Sotalol

Interventions

Propranolol or Carvedilol DRUG

Propranolol or Carvedilol claim is used as the exposure group.

Propranolol or Carvedilol

Atenolol, Bisoprolol or Sotalol DRUG

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

Atenolol, Bisoprolol or Sotalol

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• 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 Propranolol or Carvedilol to hydrochlorothiazide. The patients will be required to have continuous enrollment during the baseline period of 365 days before initiation of Propranolol or Carvedilol or Atenolol, Bisoprolol or Sotalol (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
• \. Enrollment in Medicare Part A, B, and D with no HMO coverage for 365 days prior to and including cohort entry date
• \. At least 1 inpatient claim or 2 outpatient claims with hypertension diagnosis recorded in 365 days prior to drug initiation

You may not qualify if:

• \. Prior history of dementia measured anytime prior to cohort entry date
• \. Prior history of nursing home admission in the 365 days prior to the cohort entry date
• \. Prior use of Propranolol, Carvedilol and Atenolol, Bisoprolol, Sotalol
• \. Use of Propranolol, Carvedilol and Atenolol, Bisoprolol, Sotalol concomitantly on index 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, 02115, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Propranolol; Carvedilol; Atenolol; Bisoprolol; Sotalol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring; Ethanolamines

Results Point of Contact

• Title: Rishi J Desai, PhD
• Organization: Brigham and Women's Hospital

rdesai@bwh.harvard.edu

6172780932

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: March 3, 2023
• First Posted: April 3, 2023
• Study Start: November 30, 2022
• Primary Completion: January 1, 2023
• Study Completion: December 31, 2023
• Last Updated: November 10, 2025
• Results First Posted: November 10, 2025

Record last verified: 2025-10

Locations

US (1)