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Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - Salbutamol vs Long-acting Muscarinic Antagonists

Mass General Brigham logo

Mass General Brigham

Status

Completed

Conditions

Chronic Obstructive Pulmonary Disease

Treatments

Drug: LAMA
Drug: Salbutamol

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT05457868
2019A010961-9

Details and patient eligibility

About

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.

Full 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.

Enrollment

124,117 patients

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Please see https://docs.google.com/spreadsheets/d/1j53_NBnEVQik4Ps5a9pZOvuHm1mWHCRZ3DAvI0y8NO8/edit?usp=sharing or Appendix A (https://drive.google.com/file/d/1uC_G8TJ1ujoJbas1p1gFaYFzY7Hw7xMq/view?usp=sharing) for full code and algorithm definitions.

Medicare timeframe: 2008 to 2018 (end of data availability).

Inclusion Criteria:

    1. Aged >/= 65 years on the index date
    1. No prior use of Salbutamol and Long-acting Muscarinic Antagonists (LAMA) anytime prior to cohort entry 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 two claims with COPD diagnosis measured 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

Trial design

124,117 participants in 2 patient groups

Salbutamol
Description:
Exposure group
Treatment:
Drug: Salbutamol
Long-acting muscarinic antagonists (LAMA)
Description:
Reference group
Treatment:
Drug: LAMA

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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