[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100316662":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":26,"locations":36,"responsibleParty":142,"collaborators":26,"id":144,"slug":145,"hasResults":146,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":150,"eligibilityCriteria":151,"healthyVolunteers":146,"sex":152,"minAge":153,"maxAge":26,"enrollmentInfo":154,"targetDuration":26,"studyType":157,"phases":158,"briefSummary":160,"conditions":161,"keywords":26,"overallStatus":163,"whyStopped":26,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":172},{"fullName":5,"class":6},"IntelGenx Corp.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Drug: Montelukast buccal film",{"label":15,"type":16,"description":17,"interventionNames":18},"Group B","PLACEBO_COMPARATOR","Placebo buccal film, administered once or twice daily (once in the morning and once in the evening) for 26 weeks.",[19],"Other: Placebo buccal film",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Montelukast buccal film","Film with active investigational product (montelukast) inserted and applied on inner cheek",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"OTHER","Placebo buccal film","Film with placebo (no active drug) inserted and applied on inner cheek",[15],[33],{"name":34,"affiliation":5,"role":35},"Frank A Pietrantonio, PhD","STUDY_DIRECTOR",[37,50,60,68,78,84,93,102,108,118,127,136],{"facility":38,"status":26,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":26},"Vancouver Island Health Authority","Victoria","British Columbia","V8R 1J8","Canada","CA",{"type":45,"coordinates":46},"Point",[47,48],-123.35155,48.4359,{"lat":48,"lon":47},{"facility":51,"status":26,"city":52,"state":53,"zip":54,"country":42,"countryCode":43,"cosmosGeoPoint":55,"geoPoint":59,"contacts":26},"Centricity Research (formerly True North Clinical Research)","Halifax","Nova Scotia","B3S 1N2",{"type":45,"coordinates":56},[57,58],-63.57688,44.64269,{"lat":58,"lon":57},{"facility":51,"status":26,"city":61,"state":53,"zip":62,"country":42,"countryCode":43,"cosmosGeoPoint":63,"geoPoint":67,"contacts":26},"New Minas","B4N 3R7",{"type":45,"coordinates":64},[65,66],-64.46958,45.0691,{"lat":66,"lon":65},{"facility":69,"status":26,"city":70,"state":71,"zip":72,"country":42,"countryCode":43,"cosmosGeoPoint":73,"geoPoint":77,"contacts":26},"Bruyère Research Institute","Ottawa","Ontario","K1N 5C8",{"type":45,"coordinates":74},[75,76],-75.69812,45.41117,{"lat":76,"lon":75},{"facility":79,"status":26,"city":70,"state":71,"zip":80,"country":42,"countryCode":43,"cosmosGeoPoint":81,"geoPoint":83,"contacts":26},"Recherches Neuro-Hippocampe","K1Z 1G3",{"type":45,"coordinates":82},[75,76],{"lat":76,"lon":75},{"facility":85,"status":26,"city":86,"state":71,"zip":87,"country":42,"countryCode":43,"cosmosGeoPoint":88,"geoPoint":92,"contacts":26},"Kawartha Centre - 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22\n* CT or MRI within 18 months prior to screening indicating clinical phenotype of Alzheimer's Disease\n* Treated daily with donepezil, rivastigmine or galantamine for ≥ 3 months\n* All other medications for chronic conditions should have been at a stable dose for at least 2 weeks prior to first dose.\n* No clinically meaningful abnormalities on electrocardiogram (ECG), physical examination and clinical laboratory tests\n\nExclusion Criteria:\n\n* Taken memantine within 2 months prior to screening.\n* Current diagnosis of any psychiatric disorder, depression that is not well-controlled, clinically significant or unstable systemic disease, or severe medical procedures\n* Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation.\n* Patients at imminent risk of self-harm, based on clinical interview and response on S-STS\n* 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\u002Fhis treating physician\n* History of any of the following cardiovascular conditions that an unstable:\n\n  * Hypotension\n  * Hypertension\n  * Active cardiovascular disease\n* Evidence of cerebrovascular disease\n* Have used or plan to use the following medications from 30 days prior to Visit 1 through the end of the study:\n\n  * Narcotic analgesics more frequently than on three days per week as needed for pain;\n  * Daily antipsychotic (except for risperidone, quetiapine and aripiprazole, and only if at a stable and controlled dose)\n  * 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;\n  * Daily antidepressants (except for citalopram, escitalopram, venlafaxine, trazodone, sertraline, and mirtazapine, and only if at a stable and controlled dose);\n  * Low potency antipsychotic agents (eg chlorpromazine) - not permitted at any time during the study;\n  * Anti-parkinson's disease medications (selegiline, levodopa, amantadine) for the treatment of Parkinson's Syndrome Complex;\n  * Lithium;\n  * Clozapine;\n* Previously treated with or currently using montelukast","ALL","50 Years",{"count":155,"type":156},52,"ACTUAL","INTERVENTIONAL",[159],"PHASE2","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.",[162],"Alzheimer Disease","COMPLETED","2024-04-17",{"date":166,"type":156},"2024-04-18",{"date":168,"type":156},"2018-11-26",{"date":170,"type":156},"2024-04-03",{"name":5,"class":6},12]