Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - Methotrexate vs Hydroxychloroquine

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Methotrexate; Drug: Hydroxychloroquine

• Registration Number: NCT04691505
• Lead Sponsor: Brigham and Women's Hospital

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.

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 Timeline

• Study Start: 2020-12-23
• Study First Submitted: 2020-12-28
• Study First Submitted QC: 2020-12-29
• Study First Posted: 2020-12-31
• Primary Completion: 2021-08-31
• Study Completion: 2021-08-31
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-15
• Last Update Posted: 2021-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133553

Inclusion Criteria

• 1. No prior use of methotrexate or hydroxychloroquine anytime prior to cohort entry date
• 2. Enrollment in Medicare Part A, B, and D with no HMO coverage for 365 days prior to and including cohort entry date

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Exclusion Criteria

• 1. Prior history of dementia measured anytime prior to cohort entry date
• 2. No prior history of rheumatoid arthritis recorded in the 365 days prior to cohort entry date
• 3. Prior history of nursing home admission in the 365 days prior to the cohort entry date
• 4. Prior history of DMARD use measured anytime prior to cohort entry date

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Methotrexate	Methotrexate	Reference group
Hydroxychloroquine	Hydroxychloroquine	Exposure group

Primary Outcome Measures

Name	Time	Method
Time to dementia onset	Through study completion (a median of 237 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

Name	Time	Method
Time to Alzheimer's disease onset	Through study completion (a median of 237 days)	Time to Alzheimer's disease onset. Please refer to uploaded protocol for full definition due to size limitations.

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States