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

NCT04691505 | Completed FDA Drug

• 2 other identifiers: 2019A010961-475N95019C00057
• Study Type: observational
• Target: 133,553
• 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

Rheumatoid Arthritis

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.

  Through study completion (a median of 237 days)

Secondary Outcomes (1)

• Time to Alzheimer's disease onset

  Through study completion (a median of 237 days)

Study Arms (2)

Methotrexate

Reference group

Drug: Methotrexate

Hydroxychloroquine

Exposure group

Drug: Hydroxychloroquine

Interventions

Methotrexate DRUG

Methotrexate is used as the reference group.

Methotrexate

Hydroxychloroquine DRUG

Hydroxychloroquine is used as the exposure group.

Hydroxychloroquine

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 methotrexate to hydroxychloroquine. The patients will be required to have continuous enrollment during the baseline period of 355 days before initiation of methotrexate or hydroxychloroquine (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 methotrexate or hydroxychloroquine 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 rheumatoid arthritis 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
• \. Prior history of DMARD use measured 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

Arthritis, Rheumatoid

Interventions

Methotrexate; Hydroxychloroquine

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Chloroquine; Aminoquinolines; Quinolines

Study Officials

• Rishi J Desai, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

• Madhav Thambisetty, MD, PhD

  National Institute on Aging (NIA)

  PRINCIPAL INVESTIGATOR

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: December 28, 2020
• First Posted: December 31, 2020
• Study Start: December 23, 2020
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: November 23, 2021

Record last verified: 2021-11

Locations

US (1)