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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 |
|---|---|---|---|
| Amiloride | Exposure group |
| |
| Triamterene | Reference group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amiloride | Drug | Amiloride claim is used as the exposure 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. | Median follow up times: 1) 119 days (exp), 111 days (ref) 2) 859 days (exp), 852 days (ref) 3) 333 days (exp), 286 days (ref) 4) 120 days (exp), 111 days (ref) |
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Please see https://docs.google.com/spreadsheets/d/1IdoLUI5-bz\_1D\_0IflZovJO9e1\_3kFLc\_JLEFM030No/edit?usp=sharing or Appendix A for full code and algorithm definitions.
Medicare timeframe: 2008 to 2018 (end of data availability).
Inclusion Criteria:
Exclusion Criteria:
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This study will employ a new user, active comparator, observational cohort study design comparing amiloride to triamterene. The patients will be required to have continuous enrollment during the baseline period of 365 days before initiation of amiloride or triamterene (index date). Follow-up for the outcome (dementia) differs between analyses. Follow-up begins the day after drug initiation (analysis 1, 3, 4); 180 days after drug initiation (analysis 2).
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| Name | Affiliation | Role |
|---|---|---|
| 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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| ID | Title | Description |
|---|---|---|
| FG000 | Amiloride | Exposure group Amiloride: Amiloride claim is used as the exposure group. |
| FG001 | Triamterene | Reference group Triamterene: Triamterene claim is used as the reference group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Study cohort after 1:1 propensity score matching
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| ID | Title | Description |
|---|---|---|
| BG000 | Amiloride | Exposure group Amiloride: Amiloride claim is used as the exposure group. |
| BG001 | Triamterene | Reference group Triamterene: Triamterene claim is used as the reference group. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Study cohort after 1:1 propensity score matching | Posted | Number | 95% Confidence Interval | Incidence rate per 1000 person year | Median follow up times: 1) 119 days (exp), 111 days (ref) 2) 859 days (exp), 852 days (ref) 3) 333 days (exp), 286 days (ref) 4) 120 days (exp), 111 days (ref) |
|
'As-treated' follow-up approach - Median follow-up days of 119 (for Amiloride) and 111 (for Triamterene)
Our study did not capture Serious Adverse Events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Amiloride | Exposure group Amiloride: Amiloride claim is used as the exposure group. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rishi J Desai, PhD | Brigham and Women's Hospital | 617-278-0932 | rdesai@bwh.harvard.edu |
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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 | Jul 11, 2022 | Jul 11, 2022 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000584 | Amiloride |
| D014223 | Triamterene |
| ID | Term |
|---|---|
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011621 | Pteridines |
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| Triamterene |
| Drug |
Triamterene claim is used as the reference group. |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Dementia risk factors | Count of Participants | Participants |
|
Reference group
Triamterene: Triamterene claim is used as the reference group.
|
|
| 0 |
| 7,305 |
| 0 |
| 0 |
| 0 |
| 7,305 |
| EG001 | Triamterene | Reference group Triamterene: Triamterene claim is used as the reference group. | 0 | 7,305 | 0 | 0 | 0 | 7,305 |
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| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |