Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - Montelukast vs Fluticasone

NCT05457855 | Completed Results FDA Drug

• 1 other identifier: 2019P003607-10
• Study Type: observational
• Target: 51,533
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

Study Arms (2)

Montelukast

Exposure group

Drug: Montelukast

Fluticasone

Reference group

Drug: Fluticasone

Interventions

Montelukast DRUG

Montelukast claim is used as the exposure group.

Montelukast

Fluticasone DRUG

Fluticasone claim is used as the reference group.

Fluticasone

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• \. Aged \>/= 65 years on the index date
• \. No prior use of Montelukast and Fluticasone anytime prior to cohort entry date
• \. Enrollment in Medicare Part A, B, and D with no HMO coverage for 365 days prior to and including cohort entry date
• \. At least two claims with asthma diagnosis measured 365 days prior to drug init

You may not qualify if:

• \. Prior history of dementia measured anytime prior to cohort entry date
• \. Prior history of nursing home admission in the 365 days prior to the cohort entry date

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Institute on Aging (NIA): collaborator
• Rutgers University: collaborator
• Johns Hopkins University: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

montelukast; Fluticasone

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Rishi J Desai, PhD
• Organization: Brigham and Women's Hospital

rdesai@bwh.harvard.edu

617-278-0932

Study Officials

• Madhav Thambisetty, MD, PhD

  National Institute on Aging (NIA)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 14, 2022
• Study Start: February 1, 2022
• Primary Completion: July 7, 2023
• Study Completion: December 31, 2023
• Last Updated: August 11, 2025
• Results First Posted: August 11, 2025

Record last verified: 2025-07

Locations

US (1)