Trial Outcomes & Findings for Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM)- Semaglutide v DPP4 Inhibitors (NCT NCT05768945)
NCT ID: NCT05768945
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
742670 participants
Primary outcome timeframe
Median follow up times: 1) 98 days (exp), 134 days (ref) 2) 118 days (exp), 132 days (ref) 3) 90 days (exp), 308 days (ref) 4) 99 days (exp), 135 days (ref)
Results posted on
2025-11-10
Participant Flow
Participant milestones
| Measure |
Semaglutide
Exposure group
Semaglutide claim is used as the exposure group.
|
DPP4 Inhibitors
Reference group
DPP4 inhibitors (sitagliptin, saxagliptin, linagliptin, and alogliptin) claim is used as the reference group.
|
|---|---|---|
|
Overall Study
STARTED
|
9073
|
733597
|
|
Overall Study
COMPLETED
|
7129
|
7129
|
|
Overall Study
NOT COMPLETED
|
1944
|
726468
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM)- Semaglutide v DPP4 Inhibitors
Baseline characteristics by cohort
| Measure |
Semaglutide
n=7129 Participants
Exposure group
Semaglutide: Semaglutide claim is used as the exposure group.
|
DPP4 Inhibitors (Sitagliptin, Saxagliptin, Linagliptin, and Alogliptin)
n=7129 Participants
Reference group
DPP-4 inhibitor: DPP4 inhibitors (sitagliptin, saxagliptin, linagliptin, and alogliptin) claim is used as the reference group.
|
Total
n=14258 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
|
7129 Participants
n=5 Participants
|
7129 Participants
n=20 Participants
|
14258 Participants
n=40 Participants
|
|
Age, Continuous
|
70.71 years
STANDARD_DEVIATION 4.52 • n=5 Participants
|
70.70 years
STANDARD_DEVIATION 4.65 • n=20 Participants
|
70.71 years
STANDARD_DEVIATION 4.60 • n=40 Participants
|
|
Sex: Female, Male
Female
|
3406 Participants
n=5 Participants
|
3342 Participants
n=20 Participants
|
6748 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
3723 Participants
n=5 Participants
|
3787 Participants
n=20 Participants
|
7510 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
White
|
5943 Participants
n=5 Participants
|
5968 Participants
n=20 Participants
|
11911 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Black
|
547 Participants
n=5 Participants
|
531 Participants
n=20 Participants
|
1078 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
130 Participants
n=5 Participants
|
116 Participants
n=20 Participants
|
246 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Asian
|
131 Participants
n=5 Participants
|
141 Participants
n=20 Participants
|
272 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
North American Native
|
44 Participants
n=5 Participants
|
44 Participants
n=20 Participants
|
88 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Other
|
139 Participants
n=5 Participants
|
132 Participants
n=20 Participants
|
271 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
195 Participants
n=5 Participants
|
197 Participants
n=20 Participants
|
392 Participants
n=40 Participants
|
|
Dementia risk factors
Anxiety
|
1094 Participants
n=5 Participants
|
1073 Participants
n=20 Participants
|
2167 Participants
n=40 Participants
|
|
Dementia risk factors
Bipolar Disorder
|
131 Participants
n=5 Participants
|
145 Participants
n=20 Participants
|
276 Participants
n=40 Participants
|
|
Dementia risk factors
Hypertension
|
6650 Participants
n=5 Participants
|
6618 Participants
n=20 Participants
|
13268 Participants
n=40 Participants
|
|
Dementia risk factors
Coronary artery disease
|
2527 Participants
n=5 Participants
|
2578 Participants
n=20 Participants
|
5105 Participants
n=40 Participants
|
|
Dementia risk factors
Obesity
|
4005 Participants
n=5 Participants
|
4030 Participants
n=20 Participants
|
8035 Participants
n=40 Participants
|
|
Dementia risk factors
Schizophrenia
|
15 Participants
n=5 Participants
|
20 Participants
n=20 Participants
|
35 Participants
n=40 Participants
|
|
Dementia risk factors
Depression
|
1335 Participants
n=5 Participants
|
1362 Participants
n=20 Participants
|
2697 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Median follow up times: 1) 98 days (exp), 134 days (ref) 2) 118 days (exp), 132 days (ref) 3) 90 days (exp), 308 days (ref) 4) 99 days (exp), 135 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
| Measure |
Semaglutide
n=7129 Participants
Exposure group
Semaglutide claim is used as the exposure group.
|
DPP4 Inhibitors
n=7129 Participants
Reference group
DPP4 inhibitors (sitagliptin, saxagliptin, linagliptin, and alogliptin) claim is used as the reference group.
|
|---|---|---|
|
Time to Dementia Onset
Analysis 1
|
4.40 Incidence rate per 1000 person year
Interval 2.27 to 7.68
|
6.06 Incidence rate per 1000 person year
Interval 3.7 to 9.36
|
|
Time to Dementia Onset
Analysis 2
|
4.69 Incidence rate per 1000 person year
Interval 1.28 to 12.02
|
6.71 Incidence rate per 1000 person year
Interval 2.7 to 13.83
|
|
Time to Dementia Onset
Analysis 3
|
2.80 Incidence rate per 1000 person year
Interval 0.34 to 10.13
|
10.24 Incidence rate per 1000 person year
Interval 6.96 to 14.54
|
|
Time to Dementia Onset
Analysis 4
|
0.37 Incidence rate per 1000 person year
Interval 0.01 to 2.04
|
0.61 Incidence rate per 1000 person year
Interval 0.07 to 2.19
|
Adverse Events
Semaglutide
Serious events: 0 serious events
Other events: 0 other events
Deaths: 24 deaths
DPP4 Inhibitors
Serious events: 0 serious events
Other events: 0 other events
Deaths: 44 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