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

Active, not recruiting

• Conditions: Hypertension
• Interventions: Drug: Atenolol, Bisoprolol or Sotalol; Drug: Propranolol or Carvedilol

• Registration Number: NCT05794997
• Lead Sponsor: Brigham and Women's Hospital

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.

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 Timeline

• Study Start: 2022-11-30
• Primary Completion: 2023-01-01
• Study First Submitted: 2023-03-03
• Study First Submitted QC: 2023-03-29
• Study First Posted: 2023-04-03
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-17
• Last Update Posted: 2023-07-19
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 817337

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Atenolol, Bisoprolol or Sotalol	Atenolol, Bisoprolol or Sotalol	Reference group
Propranolol or Carvedilol	Propranolol or Carvedilol	Exposure group

Primary Outcome Measures

Name	Time	Method
Time to dementia onset	From date of drug initiation until the first of dementia onset, end of Medicare enrollment, or end of study period, whichever came first, assessed up to 6 years]	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

Name	Time	Method
Time to Alzheimer's disease onset	From date of drug initiation until the first of Alzheimer's disease onset, end of Medicare enrollment, or end of study period, whichever came first, assessed up to 6 years	Time to Alzheimer's disease onset. Please refer to uploaded protocol for full definition due to size limitations.

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States