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Leukotriene Receptor Antagonist

Montelukast for Alzheimer's Disease

Phase 2
Waitlist Available
Led By Ihab Hajjar
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 year
Awards & highlights

Study Summary

This trial will compare montelukast to placebo in people with mild cognitive impairment or early Alzheimer's disease dementia. It will measure cognitive function, CSF biomarkers and neuroimaging.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Neuropsychiatric Inventory Questionnaire (NPI-Q) Score
Number of Discontinuations From Montelukast
Number of Participants With Any Gastrointestinal (GI) Symptoms
+4 more
Secondary outcome measures
CSF Amyloid
CSF Tau Levels
Clinical Dementia Rating (CDR) Score
+1 more

Side effects data

From 2005 Phase 4 trial • 99 Patients • NCT00189462
16%
Cold/Upper Respiratory Infection
10%
Diarrhea
6%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Montelukast
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Montelukast GroupExperimental Treatment1 Intervention
Montelukast (10, 20, or 40 mg)
Group II: Placebo GroupPlacebo Group1 Intervention
Matched placebo pill
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Montelukast
2008
Completed Phase 4
~15460

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,640 Previous Clinical Trials
2,560,664 Total Patients Enrolled
Ihab Hajjar5.02 ReviewsPrincipal Investigator - Emory University
Emory University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Montelukast Therapy on Alzheimer's Disease
Ihab Hajjar 2019. "Montelukast Therapy on Alzheimer's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03991988.
~6 spots leftby Apr 2025
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