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

Mass General Brigham

Status: Completed

Conditions: Peripheral Artery Disease

Treatments: Drug: Cilostazol; Drug: Pentoxifylline

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT05635370

2019P003607-12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10,398 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

10,398 participants in 2 patient groups

Pentoxifylline

Description:

Exposure group

Treatment:

Drug: Pentoxifylline

Cilostazol

Description:

Reference group

Treatment:

Drug: Cilostazol