Clinical trial

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

Name
2019A010961-9
Description
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.
Trial arms
Trial start
2021-02-01
Estimated PCD
2022-07-30
Trial end
2023-12-31
Status
Active (not recruiting)
Treatment
Salbutamol
Salbutamol claim is used as the exposure group.
Arms:
Salbutamol
LAMA
Long-acting muscarinic antagonists (LAMA) - umeclidinium, aclidinium, tiotropium, glycopyrolate, glycopyrronium - claim is used as the reference group.
Arms:
Long-acting muscarinic antagonists (LAMA)
Size
124117
Primary endpoint
Time to dementia onset
Through study completion (a median of 120 days)
Eligibility 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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 124117, 'type': 'ACTUAL'}}
Updated at
2023-07-18

1 organization

2 products

1 indication

Product
Salbutamol
Product
LAMA