Double Blind Crossover Clinical Trial of Nabilone for Agitation in Frontotemporal Dementia
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.
• Men and women over 18 years
• 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.
• Meets International Psychogeriatric Association criteria for agitation in cognitive disorders19
• CMAI score of 39 or above
• Stable psychoactive medication for 2 weeks prior to screening (all medications allowed) with no intention to change dose during treatment period
• Available study partner with ≥10 hours per week in-person contact with the patient. This can either be a friend/family member or a staff member at an assisted living facility.
• Capacity to provide written consent in English or French, or consent from official surrogate decision maker in case of incapacity
⁃ Rationale 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.