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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04691505
• Other study ID #: 2019A010961-4
• Secondary ID: 75N95019C00057
• Status: Completed
• Start date: December 23, 2020
• Est. completion date: August 31, 2021

Study information

• Verified date: November 2021
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133553
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Please see https://docs.google.com/spreadsheets/d/14HJn7W3NfPFcaowVDniCi9ulLRKRN2fn2jyeJjGgtzc/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 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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Methotrexate
Methotrexate is used as the reference group.
• Hydroxychloroquine
Hydroxychloroquine is used as the exposure group.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Johns Hopkins University, National Institute on Aging (NIA), Rutgers University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to Alzheimer's disease onset	Time to Alzheimer's disease onset. Please refer to uploaded protocol for full definition due to size limitations.	Through study completion (a median of 237 days)