BUENA

CompletedPhase 2

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

A Randomized Phase IIa, Multi-center, Double-blind, Placebo-controlled Study to Assess the Safety, Feasibility, Tolerability, and Efficacy of a New Buccal Film of Montelukast in Patients With Mild to Moderate Alzheimer's Disease

Lead sponsor

IntelGenx Corp.

Asset

Montelukast

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•mild-to-moderate AD•MMSE 14-22

Primary endpoint

•Global Neuropsychological test battery (NTB) Composite

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDIGX-CLI-2017-001

NCT IDNCT03402503

Timeline

Milestones

Study first posted2018-01-18actual

Study start2018-11-26actual

Primary completion2024-03-13actual

Study completion2024-04-03actual

Last update posted2024-04-18actual

Assets

Drug assets

Montelukast

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Mild to moderate Alzheimer's Disease.

•MMSE score of 14 - 22

•CT or MRI within 18 months prior to screening indicating clinical phenotype of Alzheimer's Disease

•Treated daily with donepezil, rivastigmine or galantamine for ≥ 3 months

•All other medications for chronic conditions should have been at a stable dose for at least 2 weeks prior to first dose.

•No clinically meaningful abnormalities on electrocardiogram (ECG), physical examination and clinical laboratory tests

Exclusion criteria

•Taken memantine within 2 months prior to screening.

•Current diagnosis of any psychiatric disorder, depression that is not well-controlled, clinically significant or unstable systemic disease, or severe medical procedures

•Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation.

•Patients at imminent risk of self-harm, based on clinical interview and response on S-STS

•History of malignancy occurring within 5 years immediately prior to screening, except for a subject who has been adequately treated for (1) basal cell or squamous cell skin cancer, (2) in situ cervical cancer, (3) localized prostate carcinoma, or (4) who has undergone potentially curative therapy with no evidence of recurrence for more than 3 years post-therapy, and who is deemed at low risk for recurrence by her/his treating physician

•History of any of the following cardiovascular conditions that an unstable:

-Hypotension

-Hypertension

-Active cardiovascular disease

•Evidence of cerebrovascular disease

•Have used or plan to use the following medications from 30 days prior to Visit 1 through the end of the study:

-Narcotic analgesics more frequently than on three days per week as needed for pain;

-Daily antipsychotic (except for risperidone, quetiapine and aripiprazole, and only if at a stable and controlled dose)

-Daily anxiolytic use; however, occasional use as needed for acute agitation or to be used as a rescue anxiolytic (i.e., lorazepam and oxazepam) is acceptable as long as not used within 24 hours of a clinic visit window;

-Daily antidepressants (except for citalopram, escitalopram, venlafaxine, trazodone, sertraline, and mirtazapine, and only if at a stable and controlled dose);

-Low potency antipsychotic agents (eg chlorpromazine) - not permitted at any time during the study;

-Anti-parkinson's disease medications (selegiline, levodopa, amantadine) for the treatment of Parkinson's Syndrome Complex;

-Lithium;

-Clozapine;

•Previously treated with or currently using montelukast

Endpoints (9)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Other (unclassified)

Function / daily living

Behavior / neuropsychiatric

Safety / tolerability / PK

Other clinical outcomes

Global cognition

3 endpoints

Primary/protocol endpoint

Global Neuropsychological test battery (NTB) Composite

Time frame:To be conducted at Visit 2 (Baseline), Visit 4 (Week 6), Visit 6 (Week 12) and Visit 8 (Week 26)

change from baseline, improvement

Secondary/protocol endpoint

Global Neuropsychological test battery (NTB) Composite

Time frame:To be conducted at Visit 4 (Week 6) and Visit 6 (Week 12)

change from baseline, improvement

Secondary/protocol endpoint

Mini Mental State Examination (MMSE)

Time frame:To be conducted at Visit 1 (Screening), Visit 2 (Baseline), Visit 4 (Week 6), Visit 6 (Week 12), Visit 8 (Week 26)

Mini-Mental State Examination (MMSE)

ratio, descriptive

Function / daily living

1 endpoint

Secondary/protocol endpoint

Alzheimer's Disease Cooperative Study - Activities of Daily Living, 23-items scale (ADCS-ADL23)

Time frame:To be conducted at Visit 2 (Baseline) and Visit 8 (Week 26)

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Behavior / neuropsychiatric

1 endpoint

Secondary/protocol endpoint

Neuropsychiatric Inventory (NPI)

Time frame:To be conducted at Visit 2 (Baseline) and Visit 8 (Week 26)

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Incidence of Treatment-Emergent Adverse Events

Time frame:26 Weeks

event count, event

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint

Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC)

Time frame:To be conducted at Visit 2 (Baseline) and Visit 8 (Week 26)

descriptive

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Sheehan Suicide Tracking Scale (S-STS)

Time frame: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)

descriptive

Secondary/protocol endpoint/low confidence

Incontinency Frequency Rating

Time frame:If there is a known history of incontinence, ratings 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)

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.