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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05457868
Enrollment
124117
Registered
2022-07-14
Start date
2021-02-01
Completion date
2023-12-31
Last updated
2025-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

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.

Interventions

DRUGSalbutamol

Salbutamol claim is used as the exposure group.

DRUGLAMA

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

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
Rutgers University
CollaboratorOTHER
Johns Hopkins University
CollaboratorOTHER
Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

Inclusion 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 * 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

Design outcomes

Primary

MeasureTime frameDescription
Time to dementia onsetThrough 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

MeasureTime frameDescription
Time to Alzheimer's disease onsetThrough 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026