Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines - (DREAM) Probenecid vs Allopurinol

NCT04746989 | Completed Results FDA Drug

• 2 other identifiers: 2019A010961-575N95019C00057
• Study Type: observational
• Target: 294,878
• 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

Gout

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) 36 days (exp), 214 days (ref) 2) 1095 days (exp), 1095 days (ref) 3) 565 days (exp), 372 days (ref) 4) 36 days (exp), 248 days (ref)

Study Arms (2)

Probenecid

Exposure group

Drug: Probenecid

Allopurinol

Reference group

Drug: Allopurinol

Interventions

Probenecid DRUG

Probenecid claim is used as the exposure group.

Probenecid

Allopurinol DRUG

Allopurinol claim is used as the reference group.

Allopurinol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will involve a new user, parallel group, cohort study design comparing probenecid to allopurinol. The patients will be required to have continuous enrollment during the baseline period of 365 days before initiation of probenecid or allopurinol (cohort entry date). Follow-up for the outcome (incident dementia), begins the day after drug initiation for analyses 1, 3, and 4 and 180 days after drug initiation for analysis 2.

You may qualify if:

• \. No prior use of urate-lowering agents, including probenecid and allopurinol 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

You may not qualify if:

• \. Prior history of dementia measured anytime prior to cohort entry date
• \. No prior history of gout 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

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

Gout

Interventions

Probenecid; Allopurinol

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

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

rdesai@bwh.harvard.edu

6172780932

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

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 10, 2021
• Study Start: February 1, 2021
• Primary Completion: July 17, 2023
• Study Completion: December 31, 2023
• Last Updated: February 27, 2026
• Results First Posted: February 27, 2026

Record last verified: 2026-02

Locations

US (1)