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NCT03991988 · ClinicalTrials.gov registry record · Phase 2
Montelukast Therapy on Alzheimer's Disease
A Phase 2 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 2
- Development phase
- 32
- Enrollment target
NCT03991988: Completed Phase 2 study, sponsored by Emory University.
NCT03991988 is a Phase 2 study that has completed, run by Emory University. The registered enrollment target is 32 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03991988, a Phase 2 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 32 participants
- Enrollment target
Study 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.
Primary Outcome
Number of participants with any GI symptoms reported: diarrhea, nausea, vomiting
Interventions
- DRUG Montelukast
- DRUG Placebo oral tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2019-09-25 |
| Est. Completion | 2022-11-18 |
| Phase | Phase 2 |
What the finished NCT03991988 record still lists
NCT03991988 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (76% lower).
The record links to 0 conditions, and to 2 interventions - of which Montelukast is the first listed.
NCT03991988 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03991988 about?
NCT03991988 is a clinical study titled "Montelukast Therapy on Alzheimer's Disease". 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 neuroi...
What is the current status of trial NCT03991988?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2019-09-25. Estimated completion is 2022-11-18.
What interventions are being tested in trial NCT03991988?
The interventions under investigation include: Montelukast (DRUG), Placebo oral tablet (DRUG).
Who is sponsoring clinical trial NCT03991988?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03991988's enrollment target sits among peer trials
32 1563rd of 2000 higher than 423 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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