Trial Outcomes & Findings for Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - Montelukast vs Fluticasone (NCT NCT05457855)
NCT ID: NCT05457855
Last Updated: 2025-08-11
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
51533 participants
Primary outcome timeframe
Median follow up times: 1) 161 days (exp), 120 days (ref) 2) 504 days (exp), 638 days (ref) 3) 212 days (exp), 130 days (ref) 4) 162 days (exp), 120 days (ref)
Results posted on
2025-08-11
Participant Flow
Participant milestones
| Measure |
Montelukast
Exposure group
Montelukast: Montelukast claim is used as the exposure group.
|
Fluticasone
Reference group
Fluticasone: Fluticasone claim is used as the reference group.
|
|---|---|---|
|
Overall Study
STARTED
|
12575
|
38958
|
|
Overall Study
COMPLETED
|
12572
|
12572
|
|
Overall Study
NOT COMPLETED
|
3
|
26386
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - Montelukast vs Fluticasone
Baseline characteristics by cohort
| Measure |
Montelukast
n=12572 Participants
Exposure group
Montelukast: Montelukast claim is used as the exposure group.
|
Fluticasone
n=12572 Participants
Reference group
Fluticasone: Fluticasone claim is used as the reference group.
|
Total
n=25144 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12572 Participants
n=5 Participants
|
12572 Participants
n=7 Participants
|
25144 Participants
n=5 Participants
|
|
Age, Continuous
|
72.8 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
72.8 years
STANDARD_DEVIATION 6.1 • n=7 Participants
|
72.8 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8878 Participants
n=5 Participants
|
8808 Participants
n=7 Participants
|
17686 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3694 Participants
n=5 Participants
|
3764 Participants
n=7 Participants
|
7458 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
10613 Participants
n=5 Participants
|
10650 Participants
n=7 Participants
|
21263 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
831 Participants
n=5 Participants
|
881 Participants
n=7 Participants
|
1712 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
218 Participants
n=5 Participants
|
203 Participants
n=7 Participants
|
421 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
910 Participants
n=5 Participants
|
838 Participants
n=7 Participants
|
1748 Participants
n=5 Participants
|
|
Dementia risk factors
Diabetes
|
4098 Participants
n=5 Participants
|
4087 Participants
n=7 Participants
|
8185 Participants
n=5 Participants
|
|
Dementia risk factors
Obesity
|
2804 Participants
n=5 Participants
|
2808 Participants
n=7 Participants
|
5612 Participants
n=5 Participants
|
|
Dementia risk factors
Coronary artery disease
|
3338 Participants
n=5 Participants
|
3264 Participants
n=7 Participants
|
6602 Participants
n=5 Participants
|
|
Dementia risk factors
Hypertension
|
9867 Participants
n=5 Participants
|
9909 Participants
n=7 Participants
|
19776 Participants
n=5 Participants
|
|
Dementia risk factors
Anxiety
|
2235 Participants
n=5 Participants
|
2234 Participants
n=7 Participants
|
4469 Participants
n=5 Participants
|
|
Dementia risk factors
Bipolar disorder
|
126 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
246 Participants
n=5 Participants
|
|
Dementia risk factors
Schizophrenia
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Median follow up times: 1) 161 days (exp), 120 days (ref) 2) 504 days (exp), 638 days (ref) 3) 212 days (exp), 130 days (ref) 4) 162 days (exp), 120 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 |
Montelukast
n=12569 Participants
Exposure group
Montelukast: Montelukast claim is used as the exposure group.
|
Fluticasone
n=12569 Participants
Reference group
Fluticasone: Fluticasone claim is used as the reference group.
|
|---|---|---|
|
Time to Dementia Onset
Analysis 1
|
9.1 Incidence rate per 1000 person year
Interval 7.3 to 11.1
|
5.6 Incidence rate per 1000 person year
Interval 4.0 to 7.7
|
|
Time to Dementia Onset
Analysis 2
|
14.5 Incidence rate per 1000 person year
Interval 12.1 to 17.2
|
14.2 Incidence rate per 1000 person year
Interval 11.9 to 16.7
|
|
Time to Dementia Onset
Analysis 3
|
11.4 Incidence rate per 1000 person year
Interval 8.7 to 14.9
|
8.6 Incidence rate per 1000 person year
Interval 5.8 to 12.4
|
|
Time to Dementia Onset
Analysis 4
|
3.5 Incidence rate per 1000 person year
Interval 2.4 to 4.8
|
1.8 Incidence rate per 1000 person year
Interval 0.97 to 3.1
|
Adverse Events
Montelukast
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Fluticasone
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