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Completed

NCT Number: NCT04691505

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

methotrexate

Drug

Methotrexate is used as the reference group.

Hydroxychloroquine

Drug

Hydroxychloroquine is used as the exposure group.

Primary outcomes

  1. Time to dementia onset

    Time frame: 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 outcomes

  1. Time to Alzheimer's disease onset

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Johns Hopkins University
  • National Institute on Aging (NIA)
  • Rutgers University

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 31, 2020
Registry last updated
Nov 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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