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| ID | Type | Description | Link |
|---|---|---|---|
| 75N95019C00057 | Other Grant/Funding Number | National Institute on Aging |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| Rutgers University | OTHER |
| Johns Hopkins University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tofacitinib | Reference group |
| |
| Abatacept | Exposure group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tofacitinib | Drug | Tofacitinib claim is used as the reference group. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time to dementia onset | 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 231 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Alzheimer's disease onset | Time to Alzheimer's disease onset. Please refer to uploaded protocol for full definition due to size limitations. | Through study completion (a median of 231 days) |
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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:
Exclusion Criteria:
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This study will involve a new user, parallel group, cohort study design comparing tofacitinib to abatacept. The patients will be required to have continuous enrollment during the baseline period of 355 days before initiation of tofacitinib 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.
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| Name | Affiliation | Role |
|---|---|---|
| Rishi J Desai, PhD | Brigham and Women's Hospital | Principal Investigator |
| Madhav Thambisetty, MD, PhD | National Institute on Aging (NIA) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02120 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 24, 2020 | Nov 24, 2020 | Prot_SAP_003.pdf |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C479163 | tofacitinib |
| D000069594 | Abatacept |
| ID | Term |
|---|---|
| D018796 | Immunoconjugates |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
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| Abatacept |
| Drug |
Abatacept claim is used as the exposure group. |
|
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |