Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM)- PDE5
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13,021
- 试验地点
- 1
- 主要终点
- Time to Dementia Onset
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged > 65 years on the index date
- •No prior use of PDE5 inhibitors (sildenafil, tadalafil) and endothelin receptor antagonists (bosentan, ambrisentan, macitentan) anytime prior to cohort entry date
- •Enrollment in Medicare Part A, B, and D with no HMO coverage for 365 days prior to and including cohort entry date
排除标准
- •Prior history of dementia measured anytime prior to cohort entry date
- •No prior history of pulmonary arterial hypertension recorded in the 365 days prior to cohort entry date
- •Prior history of nursing home admission in the 365 days prior to the cohort entry date
研究组 & 干预措施
PDE5 inhibitors
Exposure group
干预措施: PDE5 inhibitor (Drug)
Endothelin receptor antagonists
Reference group
干预措施: Endothelin Receptor Antagonists (Drug)
结局指标
主要结局
Time to Dementia Onset
时间窗: 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.
次要结局
未报告次要终点
研究者
Rishi J. Desai
Assistant Professor of Medicine
Brigham and Women's Hospital