Trial Outcomes & Findings for Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM)- Dihydropyridine Calcium Channel Blockers Versus Hydrochlorothiazide (NCT NCT05125224)
NCT ID: NCT05125224
Last Updated: 2025-11-06
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
163720 participants
Primary outcome timeframe
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)
Results posted on
2025-11-06
Participant Flow
Participant milestones
| Measure |
Dihydropyridine calcium channel blocker
Exposure group
Dihydropyridine calcium channel blocker: Dihydropyridine calcium channel blocker claim is used as the exposure group.
|
Hydrochlorothiazide
Reference group
Hydrochlorothiazide: Hydrochlorothiazide claim is used as the reference group.
|
|---|---|---|
|
Overall Study
STARTED
|
77152
|
86568
|
|
Overall Study
COMPLETED
|
64254
|
64254
|
|
Overall Study
NOT COMPLETED
|
12898
|
22314
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM)- Dihydropyridine Calcium Channel Blockers Versus Hydrochlorothiazide
Baseline characteristics by cohort
| Measure |
Dihydropyridine Calcium Channel Blocker
n=64254 Participants
Exposure group
Dihydropyridine calcium channel blocker: Dihydropyridine calcium channel blocker claim is used as the exposure group.
|
Hydrochlorothiazide
n=64254 Participants
Reference group
Hydrochlorothiazide: Hydrochlorothiazide claim is used as the reference group.
|
Total
n=128508 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=49 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=49 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
|
Age, Categorical
>=65 years
|
64254 Participants
n=49 Participants
|
64254 Participants
n=50 Participants
|
128508 Participants
n=50 Participants
|
|
Age, Continuous
|
73.44 years
STANDARD_DEVIATION 6.85 • n=49 Participants
|
73.48 years
STANDARD_DEVIATION 6.93 • n=50 Participants
|
73.44 years
STANDARD_DEVIATION 6.85 • n=50 Participants
|
|
Sex: Female, Male
Female
|
35010 Participants
n=49 Participants
|
34917 Participants
n=50 Participants
|
69927 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
29244 Participants
n=49 Participants
|
29337 Participants
n=50 Participants
|
58581 Participants
n=50 Participants
|
|
Race/Ethnicity, Customized
White
|
47346 Participants
n=49 Participants
|
47312 Participants
n=50 Participants
|
94658 Participants
n=50 Participants
|
|
Race/Ethnicity, Customized
Black
|
8092 Participants
n=49 Participants
|
8107 Participants
n=50 Participants
|
16199 Participants
n=50 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3295 Participants
n=49 Participants
|
3280 Participants
n=50 Participants
|
6575 Participants
n=50 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2463 Participants
n=49 Participants
|
2466 Participants
n=50 Participants
|
4929 Participants
n=50 Participants
|
|
Race/Ethnicity, Customized
Native American
|
471 Participants
n=49 Participants
|
472 Participants
n=50 Participants
|
943 Participants
n=50 Participants
|
|
Race/Ethnicity, Customized
Other
|
1941 Participants
n=49 Participants
|
1962 Participants
n=50 Participants
|
3903 Participants
n=50 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
646 Participants
n=49 Participants
|
655 Participants
n=50 Participants
|
1301 Participants
n=50 Participants
|
|
Dementia risk factors
Diabetes
|
45146 Participants
n=49 Participants
|
45024 Participants
n=50 Participants
|
90170 Participants
n=50 Participants
|
|
Dementia risk factors
Obesity
|
9833 Participants
n=49 Participants
|
9872 Participants
n=50 Participants
|
19705 Participants
n=50 Participants
|
|
Dementia risk factors
Coronary artery disease
|
15043 Participants
n=49 Participants
|
15080 Participants
n=50 Participants
|
30123 Participants
n=50 Participants
|
|
Dementia risk factors
Depression
|
7885 Participants
n=49 Participants
|
7906 Participants
n=50 Participants
|
15791 Participants
n=50 Participants
|
|
Dementia risk factors
Anxiety
|
7268 Participants
n=49 Participants
|
7252 Participants
n=50 Participants
|
14520 Participants
n=50 Participants
|
|
Dementia risk factors
Bipolar disorder
|
747 Participants
n=49 Participants
|
763 Participants
n=50 Participants
|
1510 Participants
n=50 Participants
|
|
Dementia risk factors
Schizophrenia
|
468 Participants
n=49 Participants
|
465 Participants
n=50 Participants
|
933 Participants
n=50 Participants
|
PRIMARY outcome
Timeframe: 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)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.
Outcome measures
| Measure |
Dihydropyridine calcium channel blocker
n=64 Participants
Exposure group
Dihydropyridine calcium channel blocker: Dihydropyridine calcium channel blocker claim is used as the exposure group.
|
Hydrochlorothiazide
n=64 Participants
Reference group
Hydrochlorothiazide: Hydrochlorothiazide claim is used as the reference group.
|
|---|---|---|
|
Time to Dementia Onset
Analysis 2
|
20.8 Incidence rate per 1000 person year
Interval 19.8 to 21.9
|
20.6 Incidence rate per 1000 person year
Interval 19.6 to 21.6
|
|
Time to Dementia Onset
Analysis 3
|
15.6 Incidence rate per 1000 person year
Interval 14.6 to 16.7
|
13.1 Incidence rate per 1000 person year
Interval 12.1 to 14.2
|
|
Time to Dementia Onset
Analysis 4
|
5.6 Incidence rate per 1000 person year
Interval 5.1 to 6.2
|
4.0 Incidence rate per 1000 person year
Interval 3.6 to 4.6
|
|
Time to Dementia Onset
Analysis 1
|
17.1 Incidence rate per 1000 person year
Interval 16.2 to 18.0
|
13.7 Incidence rate per 1000 person year
Interval 12.8 to 14.6
|
Adverse Events
Dihydropyridine calcium channel blocker
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Hydrochlorothiazide
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER