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

NCT03402503 | Completed Phase 2 DMC

• 1 other identifier: IGX-CLI-2017-001
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 12

Brief 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

Outcome Measures

Primary Outcomes (1)

• Global Neuropsychological test battery (NTB) Composite

  Evaluate if treatment with montelukast new buccal film is superior to placebo, assessed at Week 26 using the global NTB composite score. The NTB score will be used to assess cognitive and behavioral functions including problem-solving and conceptualization. The composite score will be based on an equally weighted average of standardized change from baseline scores on the following tests: International Shopping List Test (ISLT), ISLT-Delay, One Back Test, One Card Learning Test, Verbal Fluency Test, Category Fluency Test, Identification Test and Detection Test.

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

Secondary Outcomes (8)

• Global Neuropsychological test battery (NTB) Composite

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

• Mini Mental State Examination (MMSE)

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

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

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

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

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

• Neuropsychiatric Inventory (NPI)

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

Study Arms (2)

Group A

EXPERIMENTAL

Montelukast buccal film, administered 10-mg once or 30-mg twice daily (once in the morning and once in the evening) for 26 weeks.

Drug: Montelukast buccal film

Group B

PLACEBO COMPARATOR

Placebo buccal film, administered once or twice daily (once in the morning and once in the evening) for 26 weeks.

Other: Placebo buccal film

Interventions

Montelukast buccal film DRUG

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

Group A

Placebo buccal film OTHER

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

Group B

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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);

Sponsors & Collaborators

• IntelGenx Corp.: lead

Study Sites (12)

Vancouver Island Health Authority

Victoria, British Columbia, V8R 1J8, Canada

Location

Centricity Research (formerly True North Clinical Research)

Halifax, Nova Scotia, B3S 1N2, Canada

Location

Centricity Research (formerly True North Clinical Research)

New Minas, Nova Scotia, B4N 3R7, Canada

Location

Bruyère Research Institute

Ottawa, Ontario, K1N 5C8, Canada

Location

Recherches Neuro-Hippocampe

Ottawa, Ontario, K1Z 1G3, Canada

Location

Kawartha Centre - Redefining Healthy Aging

Peterborough, Ontario, K9H 2P4, Canada

Location

Gerontion Research Inc.

Toronto, Ontario, M4G 3E8, Canada

Location

Baycrest

Toronto, Ontario, M6A 2E1, Canada

Location

Recherche Neuro-Hippocampe

Gatineau, Quebec, J8T 8J1, Canada

Location

Centre hospitalier universitaire de Québec -Université Laval

Québec, Quebec, G1J 1Z4, Canada

Location

Centre de recherche sur le vieillissement, CIUSSS de l'Estrie-CHUS

Sherbrooke, Quebec, J1J 3H5, Canada

Location

Diex Recherche Sherbrooke Inc.

Sherbrooke, Quebec, J1L 0H8, Canada

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Frank A Pietrantonio, PhD

  IntelGenx Corp.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2018
• First Posted: January 18, 2018
• Study Start: November 26, 2018
• Primary Completion: March 13, 2024
• Study Completion: April 3, 2024
• Last Updated: April 18, 2024

Record last verified: 2024-04

Locations

CA (12)