Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - PDE5 Inhibitors vs Endothelin Receptor Antagonist

Pulmonary Arterial Hypertension Clinical Trial

Official title:

Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM)- PDE5 Inhibitors vs Endothelin Receptor Antagonist

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05039086
• Other study ID #: 2019A010961-8
• Status: Completed
• Start date: September 1, 2021
• Est. completion date: October 4, 2022

Study information

• Verified date: April 2024
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13021
• Est. completion date: October 4, 2022
• Est. primary completion date: September 30, 2021
• Gender: All
• Age group: 65 Years and older

Eligibility

Please see https://docs.google.com/spreadsheets/d/19NwmDi8xwWjzXqhSLPDTg4CKHt5UDQXuwCnZwY8jCS8/edit?us p=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

Related Conditions & MeSH terms

• Pulmonary Arterial Hypertension

Intervention

Drug:
• PDE5 inhibitor
PDE5 inhibitors (sildenafil, tadalafil) claim is used as the exposure group.
• Endothelin Receptor Antagonists
Endothelin receptor antagonists (bosentan, ambrisentan, macitentan) claim is used as the reference group.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Johns Hopkins University, National Institute on Aging (NIA), Rutgers University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Dementia Onset	Time to dementia onset includes: 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.; Analysis 1-'as-treated' follow-up approach: In this approach, we followed patients from cohort entry until treatment discontinuation or switch to the comparator treatment, insurance disenrollment, death, or administrative endpoint (December 2018). Treatment discontinuation was defined as occurring 90 days after the expected days supply.; of the most recently filled prescription to accommodate suboptimal adherence during treatment periods.; Analysis 2-'as-started' follow-up approach incorporating a 6-month 'induction' period.; Analysis 3-incorporating a 6-month 'symptoms to diagnosis' period Analysis 4-high-specificity outcome definition; Study accessed Medicare files (Jan 2008-Dec 2018) between September 1, 2021 to October 4, 2022.	Median follow up times: 1) 168 days (exp), 151 days (ref) 2) 693 days (exp), 720 days (ref) 3) 382 days (exp), 358 days (ref) 4) 169 days (exp), 151 days (ref)