[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bvftd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bvftd":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100617268","repetitive-transcranial-magnetic-stimulation-in-frontotemporal-lobar-degeneration-100617268",false,"NCT07316413","Repetitive Transcranial Magnetic Stimulation in Frontotemporal Lobar Degeneration","FTLD_rTMS","Inclusion Criteria:\n\n* diagnosis of FTLD (bvFTD, avPPA, svPPA, CBS, or PSP)\n* global CDR plus NACC FTLD ≤ 1\n\nExclusion Criteria:\n\n* presence of cerebrovascular disease, hydrocephalus, intracranial masses identified by MRI, history of head trauma, serious medical conditions unrelated to FTLD, history of epilepsy, and presence of electronic (e.g., pacemaker) or metallic implants in the head.","ALL","18 Years",{"count":19,"type":20},120,"ESTIMATED","INTERVENTIONAL",[23],"NA","The aim of the study is to evaluate the safety, feasibility, clinical and biological efficacy, and predictors of efficacy of an intervention consisting of repetitive transcranial magnetic stimulation (rTMS) in patients with frontotemporal dementia (FTLD) or in asymptomatic persons at risk of FTLD (i.e., persons familiar with FTLD patients).\n\nrTMS is a non-invasive brain stimulation technique, and has demonstrated the ability to modulate neuronal activity by applying high-frequency magnetic fields to the surface of the skull. rTMS offers a potentially effective means to influence neural networks involved in the pathogenesis of neurodegenerative diseases, with benefits that could extend beyond symptomatic relief. Its safety has been widely documented in a variety of clinical conditions, making it an ideal candidate for application in neurodegenerative diseases.\n\nIn the present study, participants will undergo the following procedures: (i) clinical and neuropsychological assessment, (ii) TMS, and (iii) blood sampling. The occurrence of adverse events will be monitored throughout the duration of the study.\n\nThe study is structured in two phases. In the first phase, double-blind, randomised and placebo-controlled, participants will be randomised into two groups: group 1, participants will receive real rTMS for 2 weeks; and group 2, placebo rTMS for 2 weeks. In the second, open-label phase, after 10 weeks, both group 1 and group 2 participants will receive real rTMS for 2 weeks. Each participant will receive a total of 4 weeks of intervention (4 weeks of real stimulation in group 1, or 2 weeks of real stimulation and 2 weeks of placebo stimulation in group 2), with 5 sessions per week (Monday to Friday) lasting approximately 30 minutes each.\n\nVisits will take place at the beginning of the study (T00) and after 2 weeks (T02, end of the first phase), 12 weeks (T12, beginning of the second phase), 14 weeks (T14, end of the second phase), 24 weeks (T24, follow-up). During each visit, participants underwent the following procedures: (i) clinical and neuropsychological assessment, (ii) blood sampling, and (iii) TMS. Specific biomarker analyses will be performed on the blood samples to study the pathophysiological mechanisms of the disease and the effect of the experimental intervention.",[26,27,28,29,30,31,32,33],"FTLD","FTD","bvFTD","PPA","PSP","Cortical Basal Syndrome (CBS)","rTMS","Theta Burst Stimulation","RECRUITING","2025-12-18",{"date":37,"type":38},"2026-01-05","ACTUAL",{"date":40,"type":38},"2025-02-13",{"date":42,"type":20},"2029-02-01",{"name":44,"class":45},"Università degli Studi di Brescia","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":59,"conditions":60,"keywords":64,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":80},"100496320","phase-2-nabilone-for-agitation-in-frontotemporal-dementia-100496320","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.",{"count":56,"type":20},45,[58],"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.",[61,62,63,28,29,27],"Frontotemporal Dementia","Frontotemporal Dementia, Behavioral Variant","Primary Progressive Aphasia",[65,66,67,68,69,70,27],"Nabilone","Nabilone FTD","Agitation","TEVA Nabilone","Dementia","BvFTD","2025-04-11",{"date":73,"type":38},"2025-04-15",{"date":75,"type":38},"2023-03-07",{"date":77,"type":20},"2026-05",{"name":79,"class":45},"Simon Ducharme, MD",7]