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

NCT05635370 | Completed Results FDA Drug

• 1 other identifier: 2019P003607-12
• Study Type: observational
• Target: 10,398
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peripheral Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  Median follow up times: 1) 180 days (exp), 170 days (ref) 2) 677 days (exp), 612 days (ref) 3) 211 days (exp), 173 days (ref) 4) 180 days (exp), 171 days (ref)

Study Arms (2)

Pentoxifylline

Exposure group

Drug: Pentoxifylline

Cilostazol

Reference group

Drug: Cilostazol

Interventions

Pentoxifylline DRUG

Pentoxifylline claim is used as the exposure group.

Pentoxifylline

Cilostazol DRUG

Cilostazol claim is used as the reference group.

Cilostazol

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will employ a new user, active comparator, observational cohort study design comparing Pentoxifylline versus Cilostazol. The patients will be required to have continuous enrollment during the baseline period of 365 days before initiation of study drugs (cohort entry/index date). Follow-up for the outcome (dementia) differs between analyses. Follow-up begins the day after drug initiation (analysis 1, 3, 4); 180 days after drug initiation (analysis 2).

You may qualify if:

• \. Aged \>/= 65 years on the index date
• \. Enrollment in Medicare Part A, B, and D with no HMO coverage for 365 days prior to and including cohort entry date
• \. At least two claims with peripheral artery disease diagnosis measured 365 days prior to drug initiation

You may not qualify if:

• \. Prior history of dementia measured anytime prior to cohort entry date
• \. Prior history of nursing home admission in the 365 days prior to the cohort entry date
• \. Prior history of Pentoxifylline or Cilostazol use anytime prior to cohort entry date

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Institute on Aging (NIA): collaborator
• Rutgers University: collaborator
• Johns Hopkins University: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Pentoxifylline; Cilostazol

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Quinolines

Results Point of Contact

• Title: Rishi J Desai, PhD
• Organization: Brigham and Women's Hospital

rdesai@bwh.harvard.edu

617-278-0932

Study Officials

• Madhav Thambisetty, MD, PhD

  National Institute on Aging (NIA)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 2, 2022
• Study Start: November 1, 2022
• Primary Completion: July 7, 2023
• Study Completion: December 31, 2023
• Last Updated: August 11, 2025
• Results First Posted: August 11, 2025

Record last verified: 2025-07

Locations

US (1)