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Completed

NCT Number: NCT05039086

Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - PDE5

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PDE5 inhibitor

Drug

PDE5 inhibitors (sildenafil, tadalafil) claim is used as the exposure group.

Endothelin Receptor Antagonists

Drug

Endothelin receptor antagonists (bosentan, ambrisentan, macitentan) claim is used as the reference group.

Primary outcomes

  1. Time to Dementia Onset

    Time frame: 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)

    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.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Johns Hopkins University
  • National Institute on Aging (NIA)
  • Rutgers University

Registry information

Official study title

Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM)- PDE5

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Sep 9, 2021
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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