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

NCT ID: NCT04529902

Last Updated: 2021-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

63013 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-17

Study Completion Date

2021-08-31

Brief Summary

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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

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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.

Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Tumor necrosis factor inhibitors

Reference group

Tumor Necrosis Factor Inhibitors

Intervention Type DRUG

TNFi claim is used as the reference group.

Abatacept

Exposure group

Abatacept

Intervention Type DRUG

Abatacept claim is used as the exposure group.

Interventions

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Tumor Necrosis Factor Inhibitors

TNFi claim is used as the reference group.

Intervention Type DRUG

Abatacept

Abatacept claim is used as the exposure group.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 1\. No prior use of tumor necrosis factor inhibitors 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Rutgers University

OTHER

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Rishi J. Desai

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rishi J Desai, PhD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Madhav Thambisetty, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Institute on Aging (NIA)

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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75N95019C00057

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2019A010961-3

Identifier Type: -

Identifier Source: org_study_id