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

Mass General Brigham

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Drug: Tofacitinib; Drug: Abatacept

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04529876

75N95019C00057 (Other Grant/Funding Number)

2019A010961-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29,464 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Please see https://docs.google.com/spreadsheets/d/1kUCnitJL1PpB9xkYDvBoQsKX5dnRZ6nEXhKw6p5UnlY/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 tofacitinib or abatacept 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

Trial design

29,464 participants in 2 patient groups

Tofacitinib

Description:

Reference group

Treatment:

Drug: Tofacitinib

Abatacept

Description:

Exposure group

Treatment:

Drug: Abatacept