← Back to Search

Leukotriene receptor antagonist

Montelukast for Alzheimer's Disease (BUENA Trial)

Phase 2
Waitlist Available
Research Sponsored by IntelGenx Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No clinically meaningful abnormalities on electrocardiogram (ECG), physical examination and clinical laboratory tests
Mild to moderate Alzheimer's Disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up to be conducted at all visits i.e., visit 1 (screening), visit 2 (baseline), visit 3 (week 3), visit 4 (week 6),visit 5 (week 9), visit 6 (week 12), visit 7 (week 18), and visit 8 (week 26)
Awards & highlights

BUENA Trial Summary

This trial is testing a new way to take montelukast, a drug commonly used to treat allergies, to see if it is safe and effective in treating Alzheimer's disease.

Who is the study for?
This trial is for adults with mild to moderate Alzheimer's who are already on stable Alzheimer's medications like donepezil. They should have no major heart issues, psychiatric disorders, recent cancers (with some exceptions), or be at risk of self-harm.Check my eligibility
What is being tested?
The study tests a new buccal film form of Montelukast against a placebo to see if it's safe and effective in improving symptoms of Alzheimer's disease. Participants will continue their current Alzheimer’s treatments during the trial.See study design
What are the potential side effects?
While specific side effects for the montelukast buccal film aren't listed, common ones from oral montelukast include headaches, stomach pain, and dizziness. The trial will monitor any adverse reactions.

BUENA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My heart tests, physical exam, and lab tests show no significant issues.
Select...
My condition is mild to moderate Alzheimer's Disease.
Select...
I have been taking donepezil, rivastigmine, or galantamine daily for at least 3 months.

BUENA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~to be conducted at all visits i.e., visit 1 (screening), visit 2 (baseline), visit 3 (week 3), visit 4 (week 6),visit 5 (week 9), visit 6 (week 12), visit 7 (week 18), and visit 8 (week 26)
This trial's timeline: 3 weeks for screening, Varies for treatment, and to be conducted at all visits i.e., visit 1 (screening), visit 2 (baseline), visit 3 (week 3), visit 4 (week 6),visit 5 (week 9), visit 6 (week 12), visit 7 (week 18), and visit 8 (week 26) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Alzheimer's Disease Cooperative Study - Activities of Daily Living, 23-items scale (ADCS-ADL23)
Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC)
Global Neuropsychological test battery (NTB) Composite
+5 more

BUENA Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group AExperimental Treatment1 Intervention
Montelukast buccal film, administered 10-mg once or 30-mg twice daily (once in the morning and once in the evening) for 26 weeks.
Group II: Group BPlacebo Group1 Intervention
Placebo buccal film, administered once or twice daily (once in the morning and once in the evening) for 26 weeks.

Find a Location

Who is running the clinical trial?

IntelGenx Corp.Lead Sponsor
F. Pietrantonio, PhDStudy DirectorIntelGenx Corp.
Frank A Pietrantonio, PhDStudy DirectorIntelGenx Corp.

Media Library

Montelukast buccal film (Leukotriene receptor antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT03402503 — Phase 2
Alzheimer's Disease Research Study Groups: Group A, Group B
Alzheimer's Disease Clinical Trial 2023: Montelukast buccal film Highlights & Side Effects. Trial Name: NCT03402503 — Phase 2
Montelukast buccal film (Leukotriene receptor antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03402503 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How is Montelukast buccal film typically employed?

"Montelukast buccal film is not only effective in treating exercise-induced bronchospasm, but also in managing other conditions like perennial allergic rhinitis (par), seasonal allergic rhinitis, and asthma."

Answered by AI

Are people currently being recruited for this experiment?

"The listings on clinicaltrials.gov show that this experiment is ongoing and looking for more test subjects. The trial was originally posted on 11/26/2018, with the latest update being from 11/15/2022. So far, 14 hospitals have enrolled 70 patients combined."

Answered by AI

Are there a considerable amount of hospitals running this trial in state?

"Currently, this trial is open to patients located at Recherche Neuro-Hippocampe in Gatineau, Quebec; Diex Recherche Sherbrooke Inc. in Sherbrooke, Nova Scotia; and Centre hospitalier universitaire de Québec -Université Laval in Québec City, British Columbia along with 14 other sites."

Answered by AI

Can you tell me if there is a precedent for using Montelukast in this way?

"The first study for the efficacy of montelukast buccal film was completed in 2013. As of now, there have been a total 188 studies with 22 still ongoing. A majority of these trials are situated in Gatineau, Quebec."

Answered by AI

Does the Montelukast buccal film have FDA approval?

"While there is some evidence to support the safety of Montelukast, as this drug is still in Phase 2 of clinical trials, there is currently no data supporting its efficacy."

Answered by AI

Are there any limitations on the amount of people who can be in this experiment?

"The clinical trial is currently looking for patients between 14 sites, as indicated by the information on clinicaltrials.gov. The study was originally posted on 11/26/2018 and was most recently updated on 11/15/2022. They are looking for a total of 70 patients."

Answered by AI
~8 spots leftby Apr 2025