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Safety, and Efficacy of a New Buccal Film of Montelukast in Patients With Mild to Moderate Alzheimer's Disease

NCT03402503 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2024-04-18

No results posted yet for this study

Summary

The aim of this study is to evaluate the safety, feasibility, tolerability and efficacy of a new buccal film of montelukast in patients with mild to moderate Alzheimer's disease.

Conditions

  • Alzheimer Disease

Interventions

DRUG

Montelukast buccal film

Film with active investigational product (montelukast) inserted and applied on inner cheek

OTHER

Placebo buccal film

Film with placebo (no active drug) inserted and applied on inner cheek

Sponsors & Collaborators

  • IntelGenx Corp.

    lead INDUSTRY

Principal Investigators

  • Frank A Pietrantonio, PhD · IntelGenx Corp.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-26
Primary Completion
2024-03-13
Completion
2024-04-03

Countries

  • Canada

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 NCT03402503 on ClinicalTrials.gov