Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM)- Pentoxifylline Versus Cilostazol

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM)- Pentoxifylline Versus Cilostazol

Conditions
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Peripheral Artery Disease

Intervention / Treatment
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* Drug: Pentoxifylline
* Drug: Cilostazol


Participation Criteria
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Eligibility Criteria
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Please see https://docs.google.com/spreadsheets/d/17QJ294pffmOCFYLeq0eSvn7hlj6MOb-0dJCr1RL3kfk/edit?usp=sharing or Appendix A (https://drive.google.com/drive/folders/1-lR6dR_aP44GoryjCad_NwRhjPpsIKDU?usp=sharing) 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. Enrollment in Medicare Part A, B, and D with no HMO coverage for 365 days prior to and including cohort entry date 3. At least two claims with peripheral artery disease diagnosis measured 365 days prior to drug initiation Exclusion Criteria: 1. Prior history of dementia measured anytime prior to cohort entry date 2. Prior history of nursing home admission in the 365 days prior to the cohort entry date 3. Prior history of Pentoxifylline or Cilostazol use anytime prior to cohort entry date

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pentoxifylline<br>Exposure group | Drug: Pentoxifylline<br>* Pentoxifylline claim is used as the exposure group.<br>|
| Cilostazol<br>Reference group | Drug: Cilostazol<br>* Cilostazol claim is used as the reference group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to dementia onset | Time to dementia onset, i.e., 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 due to size limitations. | up to 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Alzheimer's disease onset | Time to Alzheimer's disease onset. Please refer to uploaded protocol for full definition due to size limitations. | up to 6 years |