AsthmaNCT05457855
Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - Montelukast vs Fluticasone
An observational study of Asthma, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This study aims to evaluate the comparative risk of dementia/Alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Montelukast and Fluticasone
- How many people
- 51,533 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2022to 31 Dec 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: This study will employ a new user, active comparator, observational cohort study design comparing Montelukast versus Fluticasone. The patients will be required to have continuous enrollment during the baseline period of 365 days before initiation of study drugs (cohort entry/index date). Follow-up for the outcome (dementia) differs between analyses. Follow-up begins the day after drug initiation (analysis 1, 3, 4); 180 days after drug initiation (analysis 2).
Who may be able to join
- 1. Aged >/= 65 years on the index date
- 2. No prior use of Montelukast and Fluticasone anytime prior to cohort entry date
- 3. Enrollment in Medicare Part A, B, and D with no HMO coverage for 365 days prior to and including cohort entry date
- 4. At least two claims with asthma diagnosis measured 365 days prior to drug init
Who cannot join
- 1. Prior history of dementia measured anytime prior to cohort entry date
- 2. Prior history of nursing home admission in the 365 days prior to the cohort entry date
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02120
About this study
This study aims to evaluate the comparative risk of dementia/Alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication.
Read the detailed description
This is a non-randomized, non-interventional study that is part of the DREAM Study of Brigham and Women's Hospital. DREAM is led by Dr. Madhav Thambisetty, MD, PhD, Chief of the Clinical and Translational Neuroscience Section, Laboratory of Behavioral Neuroscience, National Institute on Aging (NIA) intramural research program. This study aims to evaluate the comparative risk of dementia/Alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication using healthcare claims data.
- Conditions
- Asthma
- Being tested
- Montelukast, Fluticasone
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MontelukastDrug
Montelukast claim is used as the exposure group.
FluticasoneDrug
Fluticasone claim is used as the reference group.
| Study group | Role | What they receive |
|---|---|---|
| Montelukast | Exposure group Receives: Drug: Montelukast | |
| Fluticasone | Reference group Receives: Drug: Fluticasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Dementia Onset
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start1 Feb 2022
- Primary completion7 Jul 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 51,533 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Rutgers University, Johns Hopkins University
- Responsible party
- Principal investigator, Rishi J. Desai, Brigham and Women's Hospital
- Investigators
- Madhav Thambisetty, MD, PhD, Principal investigator, National Institute on Aging (NIA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05457855
- Sponsor's protocol ID
- 2019P003607-10
- Status last verified
- Jul 2025
- First submitted
- 11 Jul 2022
- Last updated
- 11 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - Montelukast vs Fluticasone
- ClinicalTrials.gov ID
- NCT05457855
- Acronym / sponsor ID
- 2019P003607-10
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51,533 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Rutgers University, Johns Hopkins University
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 7 Jul 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 14 Jul 2022 (actual)
- Results
- Posted 11 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the comparative risk of dementia/Alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication.
Detailed description
This is a non-randomized, non-interventional study that is part of the DREAM Study of Brigham and Women's Hospital. DREAM is led by Dr. Madhav Thambisetty, MD, PhD, Chief of the Clinical and Translational Neuroscience Section, Laboratory of Behavioral Neuroscience, National Institute on Aging (NIA) intramural research program. This study aims to evaluate the comparative risk of dementia/Alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication using healthcare claims data.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Montelukast | – | Drug: MontelukastExposure group |
| Fluticasone | – | Drug: FluticasoneReference group |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- This study will employ a new user, active comparator, observational cohort study design comparing Montelukast versus Fluticasone. The patients will be required to have continuous enrollment during the baseline period of 365 days before initiation of study drugs (cohort entry/index date). Follow-up for the outcome (dementia) differs between analyses. Follow-up begins the day after drug initiation (analysis 1, 3, 4); 180 days after drug initiation (analysis 2).
Key inclusion criteria (4 listed)
- 1. Aged >/= 65 years on the index date
- 2. No prior use of Montelukast and Fluticasone anytime prior to cohort entry date
- 3. Enrollment in Medicare Part A, B, and D with no HMO coverage for 365 days prior to and including cohort entry date
- 4. At least two claims with asthma diagnosis measured 365 days prior to drug init
Key exclusion criteria (2 listed)
- 1. Prior history of dementia measured anytime prior to cohort entry date
- 2. Prior history of nursing home admission in the 365 days prior to the cohort entry date
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MontelukastMontelukast claim is used as the exposure group. | Drug | Montelukast |
| FluticasoneFluticasone claim is used as the reference group. | Drug | Fluticasone |
Primary outcome
Time to Dementia Onset
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Madhav Thambisetty, MD, PhD principal investigator
National Institute on Aging (NIA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Dementia Onset (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025; AzTrials last refreshed its copy on 6 Nov 2026.