Trials Sponsors Conditions Drugs Pricing

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

MontelukastDrug

Montelukast claim is used as the exposure group.

Montelukast

FluticasoneDrug

Fluticasone claim is used as the reference group.

Fluticasone

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age65 Years+

Sexall

Healthy VolunteersYes

Age GroupsOlder Adult (65+)

Sampling MethodNon-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:

Sponsors & Collaborators

Rutgers University
Othercollaborator
National Institute on Aging (NIA)
NIHcollaborator
Johns Hopkins University

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

MeSH Terms

Conditions

Asthma

Interventions

montelukastFluticasone

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

AndrostadienesAndrostenes

Results Point of Contact

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

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

Enrollment

51,533 participants (actual enrollment reported by the registry).

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

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Montelukast

Fluticasone

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Montelukast

Fluticasone

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations