Trial Outcomes & Findings for Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM)- Amiloride vs Triamterene (NCT NCT05125237)

NCT ID: NCT05125237

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

155963 participants

Primary outcome timeframe

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)

Results posted on

2025-11-06

Participant Flow

Participant milestones

Participant milestones
Measure
Amiloride
Exposure group Amiloride: Amiloride claim is used as the exposure group.
Triamterene
Reference group Triamterene: Triamterene claim is used as the reference group.
Overall Study
STARTED
7476
148487
Overall Study
COMPLETED
7305
7305
Overall Study
NOT COMPLETED
171
141182

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM)- Amiloride vs Triamterene

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Amiloride
n=7305 Participants
Exposure group Amiloride: Amiloride claim is used as the exposure group.
Triamterene
n=7305 Participants
Reference group Triamterene: Triamterene claim is used as the reference group.
Total
n=14610 Participants
Total of all reporting groups
Race/Ethnicity, Customized
White
6019 Participants
n=49 Participants
6054 Participants
n=50 Participants
12073 Participants
n=50 Participants
Sex: Female, Male
Female
4253 Participants
n=49 Participants
4219 Participants
n=50 Participants
8472 Participants
n=50 Participants
Sex: Female, Male
Male
3052 Participants
n=49 Participants
3086 Participants
n=50 Participants
6138 Participants
n=50 Participants
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
7305 Participants
n=49 Participants
7305 Participants
n=50 Participants
14610 Participants
n=50 Participants
Age, Continuous
74.06 years
STANDARD_DEVIATION 6.61 • n=49 Participants
74.22 years
STANDARD_DEVIATION 6.77 • n=50 Participants
74.14 years
STANDARD_DEVIATION 6.69 • n=50 Participants
Race/Ethnicity, Customized
Black
825 Participants
n=49 Participants
782 Participants
n=50 Participants
1607 Participants
n=50 Participants
Race/Ethnicity, Customized
Asian
123 Participants
n=49 Participants
120 Participants
n=50 Participants
243 Participants
n=50 Participants
Race/Ethnicity, Customized
Hispanic
126 Participants
n=49 Participants
135 Participants
n=50 Participants
261 Participants
n=50 Participants
Race/Ethnicity, Customized
Native American
23 Participants
n=49 Participants
21 Participants
n=50 Participants
44 Participants
n=50 Participants
Race/Ethnicity, Customized
Other
124 Participants
n=49 Participants
124 Participants
n=50 Participants
248 Participants
n=50 Participants
Race/Ethnicity, Customized
Unknown
65 Participants
n=49 Participants
69 Participants
n=50 Participants
134 Participants
n=50 Participants
Dementia risk factors
Diabetes
5784 Participants
n=49 Participants
5819 Participants
n=50 Participants
11603 Participants
n=50 Participants
Dementia risk factors
Obesity
1979 Participants
n=49 Participants
1961 Participants
n=50 Participants
3940 Participants
n=50 Participants
Dementia risk factors
Coronary artery disease
3087 Participants
n=49 Participants
3182 Participants
n=50 Participants
6269 Participants
n=50 Participants
Dementia risk factors
Depression
1168 Participants
n=49 Participants
1130 Participants
n=50 Participants
2298 Participants
n=50 Participants
Dementia risk factors
Anxiety
1104 Participants
n=49 Participants
1108 Participants
n=50 Participants
2212 Participants
n=50 Participants
Dementia risk factors
Bipolar disorder
121 Participants
n=49 Participants
143 Participants
n=50 Participants
264 Participants
n=50 Participants
Dementia risk factors
Schizophrenia
42 Participants
n=49 Participants
53 Participants
n=50 Participants
95 Participants
n=50 Participants

PRIMARY outcome

Timeframe: 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)

Population: Study cohort after 1:1 propensity score matching

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

Outcome measures
Measure
Amiloride
n=7305 Participants
Exposure group Amiloride: Amiloride claim is used as the exposure group.
Triamterene
n=7305 Participants
Reference group Triamterene: Triamterene claim is used as the reference group.
Time to Dementia Onset
Analysis 2
20.9 Incidence rate per 1000 person year
Interval 17.5 to 24.8
21.5 Incidence rate per 1000 person year
Interval 18.0 to 25.4
Time to Dementia Onset
Analysis 3
12.2 Incidence rate per 1000 person year
Interval 9.2 to 16.0
17.4 Incidence rate per 1000 person year
Interval 13.6 to 21.9
Time to Dementia Onset
Analysis 4
2.4 Incidence rate per 1000 person year
Interval 1.4 to 3.8
4.3 Incidence rate per 1000 person year
Interval 2.8 to 6.3
Time to Dementia Onset
Analysis 1
12.6 Incidence rate per 1000 person year
Interval 10.1 to 15.6
14.8 Incidence rate per 1000 person year
Interval 11.9 to 18.2

Adverse Events

Amiloride

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Triamterene

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

Rishi J Desai, PhD

Brigham and Women's Hospital

Phone: 617-278-0932

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place