- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04529863
Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - Tocilizumab vs Abatacept (DREAM)
November 15, 2021 updated by: Rishi J. Desai, Brigham and Women's Hospital
Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines- Tocilizumab vs Abatacept
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
30432
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02120
- Brigham and Women's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
This study will involve a new user, parallel group, cohort study design comparing tocilizumab to abatacept.
The patients will be required to have continuous enrollment during the baseline period of 355 days before initiation of tocilizumab or abatacept (cohort entry date).
Follow-up for the outcome (incident dementia), begins the day after drug initiation for analyses 1, 3, and 4 and 180 days after drug initiation for analysis 2.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Tocilizumab
Reference group
|
Tocilizumab claim is used as the reference group.
|
Abatacept
Exposure group
|
Abatacept claim is used as the exposure group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to dementia onset
Time Frame: Through 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.
|
Through study completion (a median of 250 days)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Alzheimer's disease onset
Time Frame: Through 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.
|
Through study completion (a median of 250 days)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 17, 2020
Primary Completion (Actual)
August 31, 2021
Study Completion (Actual)
August 31, 2021
Study Registration Dates
First Submitted
August 25, 2020
First Submitted That Met QC Criteria
August 25, 2020
First Posted (Actual)
August 28, 2020
Study Record Updates
Last Update Posted (Actual)
November 16, 2021
Last Update Submitted That Met QC Criteria
November 15, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Autoimmune Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Arthritis
- Arthritis, Rheumatoid
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Immune Checkpoint Inhibitors
- Abatacept
Other Study ID Numbers
- 2019A010961-1
- 75N95019C00057 (Other Grant/Funding Number: National Institute on Aging)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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