Trial Outcomes & Findings for Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM)- Propranolol/Carvedilol Versus Atenolol/Bisoprolol/Sotalol (NCT NCT05794997)

NCT ID: NCT05794997

Last Updated: 2025-11-10

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

817337 participants

Primary outcome timeframe

Median follow up times: 1) 298 days (exp), 249 days (ref) 2) 995 days (exp), 981 days (ref) 3) 515 days (exp), 448 days (ref) 4) 307 days (exp), 253 days (ref)

Results posted on

2025-11-10

Participant Flow

Participant milestones

Participant milestones
Measure
Propranolol or Carvedilol
Exposure group Propranolol or Carvedilol: Propranolol or Carvedilol claim is used as the exposure group.
Atenolol, Bisoprolol or Sotalol
Reference group Atenolol, Bisoprolol or Sotalol: Atenolol, Bisoprolol or Sotalol claim is used as the reference group.
Overall Study
STARTED
583870
233467
Overall Study
COMPLETED
222015
222015
Overall Study
NOT COMPLETED
361855
11452

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM)- Propranolol/Carvedilol Versus Atenolol/Bisoprolol/Sotalol

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Propranolol or Carvedilol
n=222015 Participants
Exposure group Propranolol or Carvedilol: Propranolol or Carvedilol claim is used as the exposure group.
Atenolol, Bisoprolol or Sotalol
n=222015 Participants
Reference group Atenolol, Bisoprolol or Sotalol: Atenolol, Bisoprolol or Sotalol claim is used as the reference group.
Total
n=444030 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=5 Participants
0 Participants
n=20 Participants
0 Participants
n=40 Participants
Age, Categorical
>=65 years
222015 Participants
n=5 Participants
222015 Participants
n=20 Participants
444030 Participants
n=40 Participants
Age, Continuous
74.77 years
STANDARD_DEVIATION 6.82 • n=5 Participants
74.75 years
STANDARD_DEVIATION 6.78 • n=20 Participants
74.77 years
STANDARD_DEVIATION 6.80 • n=40 Participants
Sex: Female, Male
Female
128266 Participants
n=5 Participants
127873 Participants
n=20 Participants
256139 Participants
n=40 Participants
Sex: Female, Male
Male
93749 Participants
n=5 Participants
94142 Participants
n=20 Participants
187891 Participants
n=40 Participants
Race/Ethnicity, Customized
White
177198 Participants
n=5 Participants
176941 Participants
n=20 Participants
354139 Participants
n=40 Participants
Race/Ethnicity, Customized
Black
22448 Participants
n=5 Participants
22557 Participants
n=20 Participants
45005 Participants
n=40 Participants
Race/Ethnicity, Customized
Hispanic
7289 Participants
n=5 Participants
7209 Participants
n=20 Participants
14498 Participants
n=40 Participants
Race/Ethnicity, Customized
Asian
7954 Participants
n=5 Participants
8042 Participants
n=20 Participants
15996 Participants
n=40 Participants
Race/Ethnicity, Customized
North American Native
1347 Participants
n=5 Participants
1426 Participants
n=20 Participants
2773 Participants
n=40 Participants
Race/Ethnicity, Customized
Other
4242 Participants
n=5 Participants
4273 Participants
n=20 Participants
8515 Participants
n=40 Participants
Race/Ethnicity, Customized
Unknown
1537 Participants
n=5 Participants
1567 Participants
n=20 Participants
3104 Participants
n=40 Participants
Dementia risk factors
Anxiety
32757 Participants
n=5 Participants
32295 Participants
n=20 Participants
65052 Participants
n=40 Participants
Dementia risk factors
Bipolar Disorder
2299 Participants
n=5 Participants
2263 Participants
n=20 Participants
4562 Participants
n=40 Participants
Dementia risk factors
Coronary artery disease
96483 Participants
n=5 Participants
96613 Participants
n=20 Participants
193096 Participants
n=40 Participants
Dementia risk factors
Depression
32918 Participants
n=5 Participants
32329 Participants
n=20 Participants
65247 Participants
n=40 Participants
Dementia risk factors
Diabetes
168274 Participants
n=5 Participants
168200 Participants
n=20 Participants
336474 Participants
n=40 Participants
Dementia risk factors
Obesity
48216 Participants
n=5 Participants
48375 Participants
n=20 Participants
96591 Participants
n=40 Participants
Dementia risk factors
Schizophrenia
1045 Participants
n=5 Participants
1064 Participants
n=20 Participants
2109 Participants
n=40 Participants

PRIMARY outcome

Timeframe: Median follow up times: 1) 298 days (exp), 249 days (ref) 2) 995 days (exp), 981 days (ref) 3) 515 days (exp), 448 days (ref) 4) 307 days (exp), 253 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
Propranolol or Carvedilol
n=222015 Participants
Exposure group Propranolol or Carvedilol: Propranolol or Carvedilol claim is used as the exposure group.
Atenolol, Bisoprolol or Sotalol
n=222015 Participants
Reference group Atenolol, Bisoprolol or Sotalol: Atenolol, Bisoprolol or Sotalol claim is used as the reference group.
Time to Dementia Onset
Analysis 1
22.96 Incidence rate per 1000 person year
Interval 22.48 to 23.45
19.84 Incidence rate per 1000 person year
Interval 19.35 to 20.33
Time to Dementia Onset
Analysis 2
26.82 Incidence rate per 1000 person year
Interval 26.22 to 27.44
25.84 Incidence rate per 1000 person year
Interval 25.25 to 26.45
Time to Dementia Onset
Analysis 3
23.03 Incidence rate per 1000 person year
Interval 22.47 to 23.6
20.21 Incidence rate per 1000 person year
Interval 19.64 to 20.79
Time to Dementia Onset
Analysis 4
7.21 Incidence rate per 1000 person year
Interval 6.95 to 7.49
6.47 Incidence rate per 1000 person year
Interval 6.2 to 6.75

Adverse Events

Propranolol or Carvedilol

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

Atenolol, Bisoprolol or Sotalol

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: 6172780932

Results disclosure agreements

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

Restriction type: OTHER