N/A
Completed N=51,533
Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - Montelukast vs Fluticasone
Source: ClinicalTrials.gov NCT05457855 ↗Enrolled (actual)
51,533
Serious AEs
—
Results posted
Aug 2025
Primary outcomePrimary: Time to Dementia Onset — 9.1; 5.6; 14.5; 14.2 Incidence rate per 1000 person year
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Dementia Onset |
9.1; 5.6; 14.5; 14.2; 11.4; 8.6 | — |
Eligibility Criteria
Please see https://docs.google.com/spreadsheets/d/1u8YFpnMHI5HprhyuY14tIgd1COZcsAWKFlbYCT7aL\_A/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 Montelukast and Fluticasone 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 asthma diagnosis measured 365 days prior to drug init
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
Data sourced from ClinicalTrials.gov (NCT05457855). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.