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

• Sponsor: Brigham and Women's Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04746989
• Collaborator: National Institute on Aging (NIA) (NIH), Rutgers University (Other), Johns Hopkins University (Other)
• Enrollment: 294,878
• Location: 1
• Actual Duration (Months): 6.9
• Patients Per Site Per Month: 42537.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gout	Drug: Probenecid; Drug: Allopurinol

Detailed 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 294878 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines- Probenecid vs Allopurinol
• Actual Study Start Date: Feb 1, 2021
• Actual Primary Completion Date: Aug 31, 2021
• Actual Study Completion Date: Aug 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Probenecid Exposure group	Drug: Probenecid; Probenecid claim is used as the exposure group.
Allopurinol Reference group	Drug: Allopurinol; Allopurinol claim is used as the reference group.

Outcome Measures

Primary Outcome Measures

1. Time to dementia onset [Through study completion (a median of 243 days)]]

   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.

Secondary Outcome Measures

1. Time to Alzheimer's disease onset [Through study completion (a median of 243 days)]]

   Time to Alzheimer's disease onset. Please refer to uploaded protocol for full definition due to size limitations.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Please see https://docs.google.com/spreadsheets/d/1N3IVoirGdWS7OiKiOWWgPHhgsSxX7SWDIhpeeZ-Ft7c/edit?us p=sharing or Appendix A for full code and algorithm definitions.

Medicare timeframe: 2007 to 2017 (end of data availability).

Inclusion Criteria:

• 1. No prior use of urate-lowering agents, including probenecid and allopurinol anytime prior to cohort entry date
• 1. Enrollment in Medicare Part A, B, and D with no HMO coverage for 365 days prior to and including cohort entry date

Exclusion Criteria:

• 1. Prior history of dementia measured anytime prior to cohort entry date
• 1. No prior history of gout recorded in the 365 days prior to cohort entry date
• 1. Prior history of nursing home admission in the 365 days prior to the cohort entry date

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brigham and Women's Hospital	Boston	Massachusetts	United States	02120

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Madhav Thambisetty, MD, PhD, National Institute on Aging (NIA)

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 12, 2021

More Information

Publications

None provided.

• Responsible Party: Rishi J. Desai, Assistant Professor, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT04746989
• Other Study ID Numbers: 2019A010961-5; 75N95019C00057
• First Posted: Feb 10, 2021
• Last Update Posted: Nov 16, 2021
• Last Verified: Nov 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Allopurinol; Probenecid

Study Results

No Results Posted as of Nov 16, 2021