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

Brigham and Women's Hospital133,553 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

133,553

Conditions

Rheumatoid Arthritis

Interventions

MethotrexateDRUG

Methotrexate is used as the reference group.

HydroxychloroquineDRUG

Hydroxychloroquine is used as the exposure group.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Please see https://docs.google.com/spreadsheets/d/14HJn7W3NfPFcaowVDniCi9ulLRKRN2fn2jyeJjGgtzc/edit?usp=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 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 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

Locations (1)

Brigham and Women's Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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.

Time frame: Through study completion (a median of 237 days)

Secondary Outcomes

Time to Alzheimer's disease onset

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

Time frame: Through study completion (a median of 237 days)

Data from ClinicalTrials.gov

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