Brigham and Women's Hospital
Boston, Massachusetts, 02120, United States
NCT Number: NCT05039086
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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Notify Me65 year and older
All sexes
Observational
Boston, Massachusetts, 02120, United States
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.
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
Exclusion criteria
PDE5 inhibitors (sildenafil, tadalafil) claim is used as the exposure group.
Endothelin receptor antagonists (bosentan, ambrisentan, macitentan) claim is used as the reference group.
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.
Brigham and Women's Hospital
Other
Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM)- PDE5
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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