Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - Tofacitinib vs Abatacept

Sponsor

Brigham and Women's Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04529876

Collaborator

National Institute on Aging (NIA) (NIH), Rutgers University (Other), Johns Hopkins University (Other)

29,464

Enrollment

Location

12.5

Actual Duration (Months)

2366.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: Tofacitinib Drug: Abatacept

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

29464 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines - Tofacitinib vs Abatacept

Actual Study Start Date :

Aug 17, 2020

Actual Primary Completion Date :

Aug 31, 2021

Actual Study Completion Date :

Aug 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Tofacitinib Reference group	Drug: Tofacitinib Tofacitinib claim is used as the reference group.
Abatacept Exposure group	Drug: Abatacept Abatacept claim is used as the exposure group.

Arm

Intervention/Treatment

Tofacitinib

Reference group

Drug: Tofacitinib

Tofacitinib claim is used as the reference group.

Abatacept

Exposure group

Drug: Abatacept

Abatacept claim is used as the exposure group.

Outcome Measures

Primary Outcome Measures

Time to dementia onset [Through study completion (a median of 231 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 Outcome Measures

Time to Alzheimer's disease onset [Through study completion (a median of 231 days)]
Time to Alzheimer's disease onset. Please refer to uploaded protocol for full definition due to size limitations.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Please see https://docs.google.com/spreadsheets/d/1kUCnitJL1PpB9xkYDvBoQsKX5dnRZ6nEXhKw6p5UnlY/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 tofacitinib or abatacept anytime prior to cohort entry date
1. 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
1. No prior history of rheumatoid arthritis recorded in the 365 days prior to cohort entry date
1. Prior history of nursing home admission in the 365 days prior to the cohort entry date

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brigham and Women's Hospital	Boston	Massachusetts	United States	02120

Sponsors and Collaborators

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

Investigators

Principal Investigator: Rishi J Desai, PhD, Brigham and Women's Hospital
Principal Investigator: Madhav Thambisetty, MD, PhD, National Institute on Aging (NIA)