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Montelukast Therapy on Alzheimer's Disease

NCT03991988 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-03-07

Study results available
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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.

Conditions

  • Alzheimer Disease

Interventions

DRUG

Montelukast

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.

DRUG

Placebo oral tablet

Participants in this arm will take a matched placebo pill daily

Sponsors & Collaborators

  • Emory University

    lead OTHER

Principal Investigators

  • Ihab Hajjar · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-25
Primary Completion
2022-11-18
Completion
2022-11-18
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03991988 on ClinicalTrials.gov