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Completed

NCT Number: NCT05457868

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • 2. No prior use of Salbutamol and Long-acting Muscarinic Antagonists (LAMA) anytime prior to cohort entry date
  • 3. Enrollment in Medicare Part A, B, and D with no HMO coverage for 365 days prior to and including cohort entry date
  • 4. 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
  • 2. Prior history of nursing home admission in the 365 days prior to the cohort entry date

Treatment and study plan

Salbutamol

Drug

Salbutamol claim is used as the exposure group.

LAMA

Drug

Long-acting muscarinic antagonists (LAMA) - umeclidinium, aclidinium, tiotropium, glycopyrolate, glycopyrronium - claim is used as the reference group.

Primary outcomes

  1. Time to dementia onset

    Time frame: Through study completion (a median of 120 days)

    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 outcomes

  1. Time to Alzheimer's disease onset

    Time frame: Through study completion (a median of 120 days)

    Time to Alzheimer's disease onset. Please refer to uploaded protocol for full definition due to size limitations.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Johns Hopkins University
  • National Institute on Aging (NIA)
  • Rutgers University

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jul 14, 2022
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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