Alzheimer DiseasePhase 2BUENANCT03402503
Safety, and Efficacy of a New Buccal Film of Montelukast in Patients With Mild to Moderate Alzheimer's Disease
A Phase 2 study testing Montelukast buccal film in people with Alzheimer Disease, run by IntelGenx Corp. at 12 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Montelukast buccal film
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 12 sitesCanada
- Study dates
- 26 Nov 2018to 3 Apr 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 20Show fewer
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Canada12 sites
Recherche Neuro-Hippocampe
Gatineau, Quebec, J8T 8J1
Centricity Research (formerly True North Clinical Research)
Halifax, Nova Scotia, B3S 1N2
Centricity Research (formerly True North Clinical Research)
New Minas, Nova Scotia, B4N 3R7
Bruyère Research Institute
Ottawa, Ontario, K1N 5C8
Recherches Neuro-Hippocampe
Ottawa, Ontario, K1Z 1G3
Kawartha Centre - Redefining Healthy Aging
Peterborough, Ontario, K9H 2P4
Centre hospitalier universitaire de Québec -Université Laval
Québec, Quebec, G1J 1Z4
Centre de recherche sur le vieillissement, CIUSSS de l'Estrie-CHUS
Sherbrooke, Quebec, J1J 3H5
Diex Recherche Sherbrooke Inc.
Sherbrooke, Quebec, J1L 0H8
Gerontion Research Inc.
Toronto, Ontario, M4G 3E8
Baycrest
Toronto, Ontario, M6A 2E1
Vancouver Island Health Authority
Victoria, British Columbia, V8R 1J8
About this study
Official title: 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
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.
Read the detailed description
This is a randomized Phase IIa, multi-center, double-blind, placebo-controlled study of a new buccal film of montelukast in patients with mild to moderate Alzheimer's Disease. Study drug (montelukast or matching placebo) will be administered once or twice daily for 26 weeks, and treatment effect will be assessed primarily using the global NTB composite score at Week 26.
Patients who consent to participate will undergo screening assessments to determine eligibility. This study will enroll patients who are ≥50 years of age with mild to moderate Alzheimer's Disease and on a stable treatment of donepezil, rivastigmine or galantamine for ≥3 months. Patients will be randomized (using a balanced block randomization schedule) to one of two treatment groups:
- Group A: Montelukast buccal film
- Group B: Matching placebo buccal film
In addition to the global NTB composite, patients will also be evaluated using the MMSE, ADCS-CGIC, ADCS-ADL23, NPI and S-STS. Patients will be followed for any safety concerns throughout the study and for 4 weeks following the last study visit.
- Conditions
- Alzheimer Disease
- Being tested
- Montelukast buccal film, Placebo buccal film
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Montelukast buccal filmDrug
Film with active investigational product (montelukast) inserted and applied on inner cheek
Placebo buccal filmOther
Film with placebo (no active drug) inserted and applied on inner cheek
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo buccal film |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Evaluate whether 6 and 12 weeks treatment with montelukast is superior to placebo, assessed using the global NTB composite scores. The NTB score will be used to assess cognitive and behavioral functions including problem-solving and conceptualization. he 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
Measured: To be conducted at Visit 4 (Week 6) and Visit 6 (Week 12)
Mini Mental State Examination (MMSE)
Evaluate whether 26 weeks of treatment with montelukast improved scores using the MMSE. The MMSE will be used to assess the subject's mental status in terms of cognitive function and level of dementia. The MMSE test will consist of an 11-question measure that will test five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. The maximum score is 30.
Measured: 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)
Evaluate whether 26 weeks of treatment with montelukast improved scores using the ADCS-CGIC. ADCS-CGIC assessment and rating will be based on investigator's observation of changes in the subject's cognitive, functional, and behavioral performance since the beginning of a clinical trial (baseline) until end of treatment (Week 8).
Measured: 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)
Evaluate whether 26 weeks of treatment with montelukast improved scores using the ADCS-ADL23. The ADCS-ADL23 outcome measurement along with the assistance of the caregiver, will measure and evaluate the change from baseline and at Week 8, in the competence and performance of the subject in conducting their basic tasks and instrumental activities of daily living.
Measured: To be conducted at Visit 2 (Baseline) and Visit 8 (Week 26)
Neuropsychiatric Inventory (NPI)
Evaluate whether 26 weeks of treatment with montelukast improves the behavioral disturbance in patients, measured by the neuropsychiatric inventory (NPI), compared to placebo. NPI is an assessment of the frequency and severity of behavioral disturbances in dementia. The inventory comprises 10 behavioural areas: delusions, hallucinations, agitation/aggression, depression, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behaviour; and 2 neurovegetative areas. Each area has a screening question between 7 and 9 follow-up questions relating to symptoms, asked if the answer to the screening question was 'yes'. Ratings will be based on frequency, severity and distress on identified behaviours. The change from Baseline and at 26 week treatment will be measured.
Measured: To be conducted at Visit 2 (Baseline) and Visit 8 (Week 26)
Sheehan Suicide Tracking Scale (S-STS)
Evaluate whether 26 weeks of treatment with montelukast affected suicidal risk, measured by the S-STS.
Measured: 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)
Incontinency Frequency Rating
Evaluate whether 26 weeks of treatment with montelukast improved bladder incontinence in patients who reported this problem, measured by recording events and observations in the incontinency frequency rating.
Measured: 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)
Incidence of Treatment-Emergent Adverse Events
Clinical safety and tolerability of montelukast film will be assessed up to Week 26 by adverse event monitoring (as assessed by CTCAE v5.0).
Measured: 26 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study start26 Nov 2018
- Primary completion13 Mar 2024
- Study completion3 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- IntelGenx Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frank A Pietrantonio, PhD, Study director, IntelGenx Corp.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03402503
- Sponsor's protocol ID
- IGX-CLI-2017-001
- Acronym
- BUENA
- Status last verified
- Apr 2024
- First submitted
- 10 Jan 2018
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03402503
- Acronym / sponsor ID
- BUENA / IGX-CLI-2017-001
- Conditions
- Alzheimer Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- IntelGenx Corp.Industry (pharma, biotech, devices)
- Study start
- 26 Nov 2018 (actual)
- Primary completion
- 13 Mar 2024 (actual)
- Study completion
- 3 Apr 2024 (actual)
- First posted
- 18 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a randomized Phase IIa, multi-center, double-blind, placebo-controlled study of a new buccal film of montelukast in patients with mild to moderate Alzheimer's Disease. Study drug (montelukast or matching placebo) will be administered once or twice daily for 26 weeks, and treatment effect will be assessed primarily using the global NTB composite score at Week 26.
Patients who consent to participate will undergo screening assessments to determine eligibility. This study will enroll patients who are ≥50 years of age with mild to moderate Alzheimer's Disease and on a stable treatment of donepezil, rivastigmine or galantamine for ≥3 months. Patients will be randomized (using a balanced block randomization schedule) to one of two treatment groups:
- Group A: Montelukast buccal film
- Group B: Matching placebo buccal film
In addition to the global NTB composite, patients will also be evaluated using the MMSE, ADCS-CGIC, ADCS-ADL23, NPI and S-STS. Patients will be followed for any safety concerns throughout the study and for 4 weeks following the last study visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Montelukast buccal filmMontelukast buccal film, administered 10-mg once or 30-mg twice daily (once in the morning and once in the evening) for 26 weeks. |
| Group B | Placebo comparator | Other: Placebo buccal filmPlacebo buccal film, administered once or twice daily (once in the morning and once in the evening) for 26 weeks. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Montelukast buccal filmFilm with active investigational product (montelukast) inserted and applied on inner cheek | Drug | Group A |
| Placebo buccal filmFilm with placebo (no active drug) inserted and applied on inner cheek | Other | Group B |
Primary outcome
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)
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.
8 secondary outcomes
Global Neuropsychological test battery (NTB) Composite
Time frame: To be conducted at Visit 4 (Week 6) and Visit 6 (Week 12)
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)
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)
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)
Neuropsychiatric Inventory (NPI)
Time frame: To be conducted at Visit 2 (Baseline) and Visit 8 (Week 26)
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)
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)
Incidence of Treatment-Emergent Adverse Events
Time frame: 26 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank A Pietrantonio, PhD study director
IntelGenx Corp.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Montelukast buccal film in people with Alzheimer Disease, run by IntelGenx Corp. at 12 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.