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

Enrollment

Location

Anticipated Duration (Months)

62664.2

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: 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.

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

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

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