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

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05794997
Collaborator
National Institute on Aging (NIA) (NIH), Rutgers University (Other), Johns Hopkins University (Other)
817,337
1
13
62664.2

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
  • Drug: Propranolol or Carvedilol
  • Drug: Atenolol, Bisoprolol or Sotalol

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 :
817337 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM)- Propranolol/Carvedilol Versus Atenolol/Bisoprolol/Sotalol
Actual Study Start Date :
Nov 30, 2022
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Propranolol or Carvedilol

Exposure group

Drug: Propranolol or Carvedilol
Propranolol or Carvedilol claim is used as the exposure group.

Atenolol, Bisoprolol or Sotalol

Reference group

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

Please see https://drive.google.com/drive/folders/1eqhYGcjNDNnk_cKTgiKQyX3ntdD3xLnY?usp=sharing or Appendix A for full code and algorithm definitions.

Medicare timeframe: 2008 to 2019 (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 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
    1. Prior history of nursing home admission in the 365 days prior to the cohort entry date
    1. Prior use of Propranolol, Carvedilol and Atenolol, Bisoprolol, Sotalol
    1. Use of Propranolol, Carvedilol and Atenolol, Bisoprolol, Sotalol concomitantly on index date

Contacts and Locations

Locations

Site City State Country Postal Code
1 Brigham and Women's Hospital Boston Massachusetts United States 02115

Sponsors and Collaborators

  • Brigham and Women's Hospital
  • National Institute on Aging (NIA)
  • Rutgers University
  • Johns Hopkins University

Investigators

  • Principal Investigator: Madhav Thambisetty, MD, PhD, National Institute on Aging (NIA)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rishi J. Desai, Assistant Professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT05794997
Other Study ID Numbers:
  • 2019P003607-13
First Posted:
Apr 3, 2023
Last Update Posted:
Apr 3, 2023
Last Verified:
Mar 1, 2023
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 3, 2023