Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| Rutgers University | OTHER |
| Johns Hopkins University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dihydropyridine calcium channel blocker | Exposure group |
| |
| Hydrochlorothiazide | Reference group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dihydropyridine calcium channel blocker | Drug | Dihydropyridine calcium channel blocker 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) 189 days (exp), 171 days (ref) 2) 835 days (exp). 851 days (ref) 3) 388 days (exp), 348 days (ref) 4) 191 days (exp), 172 days (ref) |
Not provided
Not provided
Please see https://docs.google.com/spreadsheets/d/1VlyY3zcxoRp0tH7yv8rSOEggSO6WQ0VYEjq-6KlSSt8/edit?usp=sharing or Appendix A for full code and algorithm definitions.
Medicare timeframe: 2008 to 2018 (end of data availability). CRPD timeframe: 2007 to 2018
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
This study will employ a new user, active comparator, observational cohort study design comparing dihydropyridine CCBs to hydrochlorothiazide. The patients will be required to have continuous enrollment during the baseline period of 365 days before initiation of dihydropyridine CCBs or hydrochlorothiazide (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).
Not provided
| 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 |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Dihydropyridine calcium channel blocker | Exposure group Dihydropyridine calcium channel blocker: Dihydropyridine calcium channel blocker claim is used as the exposure group. |
| FG001 | Hydrochlorothiazide |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| 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 23, 2021 |
Not provided
Not provided
Not provided
Not provided
| Hydrochlorothiazide | Drug | Hydrochlorothiazide claim is used as the reference group. |
|
Reference group
Hydrochlorothiazide: Hydrochlorothiazide claim is used as the reference group.
| COMPLETED |
|
| NOT COMPLETED |
|
Medicare - Study cohort after 1:1 propensity score matching
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Dihydropyridine Calcium Channel Blocker | Exposure group Dihydropyridine calcium channel blocker: Dihydropyridine calcium channel blocker claim is used as the exposure group. |
| BG001 | Hydrochlorothiazide | Reference group Hydrochlorothiazide: Hydrochlorothiazide claim is used as the reference group. |
| BG002 | Total | Total of all reporting groups |
| 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 | 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 |
|
| 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. | Posted | Number | 95% Confidence Interval | Incidence rate per 1000 person year | Median follow up times: 1) 189 days (exp), 171 days (ref) 2) 835 days (exp). 851 days (ref) 3) 388 days (exp), 348 days (ref) 4) 191 days (exp), 172 days (ref) |
|
|
|
'As-treated' follow-up approach - Median follow-up days of 189 (for Dihydropyridine Calcium Channel Blockers) and 171 (for Hydrochlorothiazide)
Our study did not capture Serious Adverse Events.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dihydropyridine calcium channel blocker | Exposure group Dihydropyridine calcium channel blocker: Dihydropyridine calcium channel blocker claim is used as the exposure group. | 0 | 64,254 | 0 | 0 | 0 | 64,254 |
| EG001 | Hydrochlorothiazide | Reference group Hydrochlorothiazide: Hydrochlorothiazide claim is used as the reference group. | 0 | 64,254 | 0 | 0 | 0 | 64,254 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rishi J Desai, PhD | Brigham and Women's Hospital | 617-278-0932 | rdesai@bwh.harvard.edu |
| Nov 23, 2021 |
| Prot_SAP_001.pdf |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D006852 | Hydrochlorothiazide |
| ID | Term |
|---|---|
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D049971 | Thiazides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Black |
|
| Asian |
|
| Hispanic |
|
| Native American |
|
| Other |
|
| Unknown |
|
| Obesity |
|
| Coronary artery disease |
|
| Depression |
|
| Anxiety |
|
| Bipolar disorder |
|
| Schizophrenia |
|
| Analysis 3 |
|
| Analysis 4 |
|