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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04529863
Acronym
DREAM
Enrollment
30432
Registered
2020-08-28
Start date
2020-08-17
Completion date
2021-08-31
Last updated
2021-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

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.

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.

Interventions

DRUGTocilizumab

Tocilizumab claim is used as the reference group.

DRUGAbatacept

Abatacept claim is used as the exposure group.

Sponsors

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

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Please see https://docs.google.com/spreadsheets/d/1paz3s8atiPsH8kyaCgxB8gcqQYNnK1Cv\_om79IfIAsI/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 tocilizumab 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

Design outcomes

Primary

MeasureTime frameDescription
Time to dementia onsetThrough study completion (a median of 250 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

MeasureTime frameDescription
Time to Alzheimer's disease onsetThrough study completion (a median of 250 days)Time to Alzheimer's disease onset. Please refer to uploaded protocol for full definition due to size limitations.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026