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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04691505
Other study ID # 2019A010961-4
Secondary ID 75N95019C00057
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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