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Leukotriene Receptor Antagonist
Montelukast Therapy on 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
Summary
This trial tests montelukast, a medication usually used for asthma, on people with early Alzheimer's disease. The goal is to see if reducing brain inflammation can help improve memory and thinking. Participants will be treated for several months. Montelukast is commonly used to treat asthma and seasonal allergies, and it has shown potential in reducing neuro-inflammation, which is a hallmark of Alzheimer's disease.
Eligible Conditions
- Alzheimer's Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Neuropsychiatric Inventory Questionnaire (NPI-Q) Score
Number of Discontinuations From Montelukast
Number of Participants With Any Gastrointestinal (GI) Symptoms
+4 moreSecondary study objectives
CSF Amyloid
CSF Tau Levels
Clinical Dementia Rating (CDR) Score
+1 moreSide effects data
From 2005 Phase 4 trial • 99 Patients • NCT0018946216%
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
1,708 Previous Clinical Trials
2,607,452 Total Patients Enrolled
Ihab Hajjar5.02 ReviewsPrincipal Investigator - Emory University
Emory University