[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100496320":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":32,"locations":43,"responsibleParty":152,"collaborators":156,"id":159,"slug":160,"hasResults":161,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":161,"sex":167,"minAge":168,"maxAge":31,"enrollmentInfo":169,"targetDuration":31,"studyType":172,"phases":173,"briefSummary":175,"conditions":176,"keywords":183,"overallStatus":46,"whyStopped":31,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":197},{"fullName":5,"class":6},"Douglas Mental Health University Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Nabilone","ACTIVE_COMPARATOR","Weeks 1-2 Nabilone and placebo will be taken orally by the patient as per the schedule provided by the research team. All patients will start with one 0.5mg capsule per day, taken before bed for the first week and then increase administration to the 1mg capsule taken before bed for the second week.\n\nWeeks 3-4 Two weeks after the start of the trial patients and study partners will attend an in person or remote Interim Assessment. If remission is not achieved and no clinically significant adverse drug reactions are reported then the dose schedule will increase to 2 capsules per day (2mg\u002Fday), 1 capsule in the morning and 1 before bed.\n\nWeeks 5-6 Four weeks after the start of the trial there will be a second in person or remote Interim Assessment identical to the first. If remission of agitation has not been achieved and no adverse drug reactions are reported the dose schedule will increase to 4 tablets per day (4mg\u002Fday), with 2 tablets in the morning and 2 before bed.",[13],"Drug: Nabilone",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Weeks 1 and 2 Participants will receive one capsule per day to be taken orally before bedtime.\n\nWeeks 3-4 Participants will receive 2 capsules per day, one in the morning and one before bedtime.\n\nWeeks 5-6 Participants will receive 2 capsules per day, one in the morning and one before bedtime.\n\nThe placebo dosing regimen is designed to be as similar as possible to the nabilone dosing regime, including using identical capsules.",[19],"Drug: Placebo",[21,28],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Nabilone is a synthetic cannabinoid that has shown benefit for agitation in Alzheimer's disease. Nabilone further has potentially beneficial properties on oxidative stress and inflammation in neurodegenerative diseases, mechanisms that have been linked to the pathophysiology of frontotemporal dementia.",[9],[26,27],"Nabilone Oral Capsule","TEVA Nabilone",{"type":22,"name":15,"description":29,"armGroupLabels":30,"otherNames":31},"The placebo is a capsule identical to the nabilone capsules that will be used in this clinical trial.",[15],null,[33,38],{"name":34,"role":35,"phone":36,"phoneExt":31,"email":37},"Simon Ducharme, MD, MA","CONTACT","15144305748","simon.ducharme@mcgill.ca",{"name":39,"role":35,"phone":40,"phoneExt":41,"email":42},"Ahmad Fakhoury, MA","5147616131","4353","ahmad.fakhoury.comtl@ssss.gouv.qc.ca",[44,66,83,98,105,117,138],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"University of British Columbia, St Paul's Hospital","RECRUITING","Vancouver","British Columbia","V6Z1Y6","Canada","CA",{"type":53,"coordinates":54},"Point",[55,56],-123.11934,49.24966,{"lat":56,"lon":55},[59,63],{"name":60,"role":35,"phone":61,"phoneExt":31,"email":62},"Benita Mudge","604 822 7990","Benita.Mudge@vch.ca",{"name":64,"role":65,"phone":31,"phoneExt":31,"email":31},"Robin Hsiung, MD","PRINCIPAL_INVESTIGATOR",{"facility":67,"status":68,"city":69,"state":70,"zip":71,"country":50,"countryCode":51,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Brain and Mind Institute, University of Western Ontario","NOT_YET_RECRUITING","London","Ontario","2P6H+GJ",{"type":53,"coordinates":73},[74,75],-81.23304,42.98339,{"lat":75,"lon":74},[78,81],{"name":79,"role":35,"phone":31,"phoneExt":31,"email":80},"Kristy Coleman","kristy.coleman@sjhc.london.on.ca",{"name":82,"role":65,"phone":31,"phoneExt":31,"email":31},"Elizabeth Finger, MD",{"facility":84,"status":46,"city":85,"state":70,"zip":86,"country":50,"countryCode":51,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Sunnybrook Health Sciences Centre","Toronto","M4N3M5",{"type":53,"coordinates":88},[89,90],-79.39864,43.70643,{"lat":90,"lon":89},[93,96],{"name":94,"role":35,"phone":31,"phoneExt":31,"email":95},"Ljubica Zotovic, MD","Ljubica.Zotovic@sunnybrook.ca",{"name":97,"role":65,"phone":31,"phoneExt":31,"email":31},"Mario Masellis, MD",{"facility":99,"status":100,"city":85,"state":70,"zip":101,"country":50,"countryCode":51,"cosmosGeoPoint":102,"geoPoint":104,"contacts":31},"Baycrest Hospital, University of Toronto","ACTIVE_NOT_RECRUITING","M6A2E1",{"type":53,"coordinates":103},[89,90],{"lat":90,"lon":89},{"facility":106,"status":46,"city":85,"state":70,"zip":107,"country":50,"countryCode":51,"cosmosGeoPoint":108,"geoPoint":110,"contacts":111},"Western Hospital - University of Toronto","MH3V+9R",{"type":53,"coordinates":109},[89,90],{"lat":90,"lon":89},[112,115],{"name":113,"role":35,"phone":31,"phoneExt":31,"email":114},"Kasey Cortez","Kasey.Cortez@uhn.ca",{"name":116,"role":65,"phone":31,"phoneExt":31,"email":31},"Carmela Tartaglia, MD",{"facility":118,"status":46,"city":119,"state":120,"zip":121,"country":50,"countryCode":51,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"CHU de Québec, Université Laval","Laval","Quebec","G1V0A6",{"type":53,"coordinates":123},[124,125],-73.692,45.56995,{"lat":125,"lon":124},[128,131,136],{"name":129,"role":35,"phone":31,"phoneExt":31,"email":130},"Mary-Christine Bourgeois","mary-christine.bourgeois@chudequebec.ca",{"name":132,"role":35,"phone":133,"phoneExt":134,"email":135},"Cassandra Roy","418-525-4444","66912","cassandra.roy@crchudequebec.ulaval.ca",{"name":137,"role":65,"phone":31,"phoneExt":31,"email":31},"Robert LaForce Jr, MD",{"facility":139,"status":46,"city":140,"state":120,"zip":141,"country":50,"countryCode":51,"cosmosGeoPoint":142,"geoPoint":146,"contacts":147},"The Douglas Research Centre","Montreal","H4H1R3",{"type":53,"coordinates":143},[144,145],-73.58781,45.50884,{"lat":145,"lon":144},[148,150],{"name":39,"role":35,"phone":149,"phoneExt":41,"email":42},"+1 (514) 761 6131",{"name":151,"role":65,"phone":31,"phoneExt":31,"email":31},"Simon Ducharme, MA, MD",{"type":153,"investigatorFullName":154,"investigatorTitle":155,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"SPONSOR_INVESTIGATOR","Simon Ducharme, MD","Associate Professor, McGill University",[157],{"name":158,"class":6},"Alzheimer's Drug Discovery Foundation","100496320","phase-2-nabilone-for-agitation-in-frontotemporal-dementia-100496320",false,"NCT05742698","Nabilone for Agitation in Frontotemporal Dementia","Double Blind Crossover Clinical Trial of Nabilone for Agitation in Frontotemporal Dementia","Nabilone-FTD","Inclusion Criteria:\n\n* Men and women over 18 years\n* Major neurocognitive disorder due to probable behavioural variant FTD (Rascovsky criteria)17 or primary progressive aphasia (Gorno-Tempini criteria)18. All ages and severity levels will be included.\n* Meets International Psychogeriatric Association criteria for agitation in cognitive disorders19\n* CMAI score of 39 or above\n* Stable psychoactive medication for 2 weeks prior to screening (all medications allowed) with no intention to change dose during treatment period\n* Available study partner with ≥10 hours per week in-person contact with the patient. This can either be a friend\u002Ffamily member or a staff member at an assisted living facility.\n* Capacity to provide written consent in English or French, or consent from official surrogate decision maker in case of incapacity\n\nRationale for Inclusion Criteria: The inclusion criteria are designed to enroll patients with FTD with the behaviours of interest, with a range of disease severity that will permit assessment of all outcome measures.\n\nExclusion Criteria:\n\n* Clinically significant psychotic symptoms (Neuropsychiatric Inventory domain score (severity x frequency) ≥4 on the delusions or hallucinations subscale)\n* Clinically significant orthostatic hypotension (a decrease in systolic blood pressure of 20 mm Hg or in diastolic blood pressure of 10 mm Hg within three minutes of standing compared to blood pressure in a seated position)\n* Symptomatic orthostatic tachycardia (heart rate increase from of at least 30 beats per minute within the first 5 minutes of standing compared to a seated position IF orthostatic hypotension is not a problem)\n* Unstable cardiovascular condition in the opinion of the investigator\n* Known or suspected history of drug or alcohol dependence or abuse in the past 12 months, including use of any psychomimetic drugs (e.g. ketamine, lysergic acid diethylamide, psilocybin).\n* Allergy, or significant adverse reaction to cannabinoids. If the adverse reaction involved psychological symptoms that are indicative of psychosis or severe anxiety the patient will be excluded. Their treating clinician may be consulted for a clinical opinion on the severity of the response to cannabis and whether this justifies exclusion from the trial.\n* Major depressive episode within 6 months of screening\n* Women who are breast feeding or pregnant\n* Severe liver dysfunction, as determined by their treating clinician\n* Other psychiatric or neurological condition that could cause significant agitation\n* Ongoing use of any cannabinoid-related products. This includes any THC or CBD based products, regardless of administration method (oral, inhalation, topical, etc…)\n\nRationale for Exclusion Criteria: The exclusion criteria are designed to avoid inclusion of patients who may have medical comorbidities that would increase their risk of serious side effects from repeated nabilone administration.","ALL","18 Years",{"count":170,"type":171},45,"ESTIMATED","INTERVENTIONAL",[174],"PHASE2","The primary goal of this study is to test the hypothesis that oral nabilone treatment will reduce agitation compared with placebo in patients with Frontotemporal Dementia (both behavioural variant frontotemporal dementia and primary progressive aphasia). The study population is defined as patients with probable Frontotemporal Dementia that meet the International Psychogeriatric Association criteria for agitation in cognitive disorders.",[177,178,179,180,181,182],"Frontotemporal Dementia","Frontotemporal Dementia, Behavioral Variant","Primary Progressive Aphasia","bvFTD","PPA","FTD",[9,184,185,27,186,187,182],"Nabilone FTD","Agitation","Dementia","BvFTD","2025-04-11",{"date":190,"type":191},"2025-04-15","ACTUAL",{"date":193,"type":191},"2023-03-07",{"date":195,"type":171},"2026-05",{"name":154,"class":6},7]