CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 32 enrolled
Drug / intervention
Montelukast +1 moredrug
Likely dose
Montelukast 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03991988
NCT03991988Phase 2Completed
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Effects of Montelukast Therapy on Alzheimer's Disease (EMERALD)

Emory University·interventional·Posted Jun 19, 2019·Updated Mar 7, 2024

In Brief

A Phase 2 clinical trial evaluating Montelukast and Placebo oral tablet for Alzheimer Disease. Completed, enrolled 32 participants across 4 sites.

Detailed Summary

This is a one-year, double-blind placebo-controlled randomized clinical trial that compares montelukast to placebo in individuals with mild cognitive impairment (MCI) and early Alzheimer's disease (AD) dementia. The measures include cognitive function, cerebrospinal fluid (CSF) biomarkers and neuroimaging (cerebral perfusion and markers of vascular brain damage). Participants will be treated with montelukast (escalating doses:10, 20 to 40 mg) or matched placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlzheimer Disease
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedJun 19, 2019
Enrollment StartSep 25, 2019
Primary CompletionNov 18, 2022
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 7.0 years ago

Interventions

Montelukastdrug

Participants in this arm will take a pill of Montelukast daily on escalating doses: 10, 20 to 40 mg. All participants will be initiated on 10 mg. The dose will be increased in 2-week increments to 20 mg and 40 mg as long as participants report no intolerable symptoms or adverse events.

Placebo oral tabletdrug

Participants in this arm will take a matched placebo pill daily