Trial · NCT05457855
Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - Montelukast vs Fluticasone
NCT05457855, Completed, Brigham and Women's Hospital; results first posted 2025-08-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - Montelukast vs Fluticasone. Trials, record NCT05457855. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05457855
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - Montelukast vs Fluticasone
- NCT number
- NCT05457855
- Status
- Completed
- Enrollment
- 51,533 participants, actual
- Lead sponsor
- Brigham and Women's Hospital
- Conditions
- Asthma
- Interventions
- Montelukast, Fluticasone
- First posted
- 2022-07-14
- Last updated
- 2025-08-11
- Results first posted
- 2025-08-11
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Dementia Onset | 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. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Dementia Onset | 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) | Incidence rate per 1000 person year | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Dementia Onset | Montelukast | Analysis 1 | 9.1 | 95% Confidence Interval 7.3 to 11.1 | Incidence rate per 1000 person year |
| Time to Dementia Onset | Fluticasone | Analysis 1 | 5.6 | 95% Confidence Interval 4.0 to 7.7 | Incidence rate per 1000 person year |
| Time to Dementia Onset | Montelukast | Analysis 2 | 14.5 | 95% Confidence Interval 12.1 to 17.2 | Incidence rate per 1000 person year |
| Time to Dementia Onset | Fluticasone | Analysis 2 | 14.2 | 95% Confidence Interval 11.9 to 16.7 | Incidence rate per 1000 person year |
| Time to Dementia Onset | Montelukast | Analysis 3 | 11.4 | 95% Confidence Interval 8.7 to 14.9 | Incidence rate per 1000 person year |
| Time to Dementia Onset | Fluticasone | Analysis 3 | 8.6 | 95% Confidence Interval 5.8 to 12.4 | Incidence rate per 1000 person year |
| Time to Dementia Onset | Montelukast | Analysis 4 | 3.5 | 95% Confidence Interval 2.4 to 4.8 | Incidence rate per 1000 person year |
| Time to Dementia Onset | Fluticasone | Analysis 4 | 1.8 | 95% Confidence Interval 0.97 to 3.1 | Incidence rate per 1000 person year |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Montelukast | 12,575 | |
| Overall Study | STARTED | Fluticasone | 38,958 | |
| Overall Study | COMPLETED | Montelukast | 12,572 | |
| Overall Study | COMPLETED | Fluticasone | 12,572 | |
| Overall Study | NOT COMPLETED | Montelukast | 3 | |
| Overall Study | NOT COMPLETED | Fluticasone | 26,386 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Montelukast | 0 | 12,569 |
| Total, all-cause mortality | Fluticasone | 0 | 12,569 |
| Total, other adverse events | Montelukast | 0 | 12,569 |
| Total, other adverse events | Fluticasone | 0 | 12,569 |
| Total, serious adverse events | Montelukast | 0 | 0 |
| Total, serious adverse events | Fluticasone | 0 | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Montelukast vs Fluticasone: deaths from any cause |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05457855
GET https://conductscience.org/api/trials/v1/NCT05457855/registered