N/A
N=13,021
Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - PDE5
Pulmonary Arterial Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT05039086 ↗Enrolled (actual)
13,021
Serious AEs
—
Results posted
Feb 2024
Primary outcome: Primary: Time to Dementia Onset — 17.9; 18.8; 19.8; 19.9 Incidence rate per 1000 person year
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- PDE5 inhibitor (Drug); Endothelin Receptor Antagonists (Drug)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Dementia Onset |
17.9; 18.8; 19.8; 19.9; 15.1; 22.6 | — |
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.
Eligibility Criteria
Please see https://docs.google.com/spreadsheets/d/19NwmDi8xwWjzXqhSLPDTg4CKHt5UDQXuwCnZwY8jCS8/edit?usp=sharing or Appendix A 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 PDE5 inhibitors (sildenafil, tadalafil) and endothelin receptor antagonists (bosentan, ambrisentan, macitentan) 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
Exclusion Criteria
- 1. Prior history of dementia measured anytime prior to cohort entry date
- 2. No prior history of pulmonary arterial hypertension recorded in the 365 days prior to cohort entry date
- 3. Prior history of nursing home admission in the 365 days prior to the cohort entry date
Data sourced from ClinicalTrials.gov (NCT05039086). 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.