Can a synthetic cannabinoid calm agitation in frontotemporal dementia?
NCT ID NCT05742698
First seen Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether nabilone, a synthetic cannabinoid, can reduce agitation in people with frontotemporal dementia (FTD). Participants receive both nabilone and a placebo in random order to compare effects. The study includes adults with behavioral variant FTD or primary progressive aphasia who meet criteria for agitation.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a synthetic cannabinoid called nabilone
- What this could lead to
- If it works, nabilone could offer a new way to ease agitation in frontotemporal dementia, a condition with few treatment options.
- What could go wrong
- This is a very small early-phase trial with only 3 participants, so results may not apply broadly. Side effects of cannabinoids can include dizziness, drowsiness, and confusion.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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3 people
The number who actually took part.
- Started
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Mar 2023
- Finished
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Dec 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * Clinically significant psychotic symptoms (Neuropsychiatric Inventory domain score (severity x frequency) ≥4 on the delusions or hallucinations subscale) * 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) * 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) * Unstable cardiovascular condition in the opinion of the investigator * 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). * 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. * Major depressive episode within 6 months of screening * Women who are breast feeding or pregnant * Severe liver dysfunction, as determined by their treating clinician * Other psychiatric or neurological condition that could cause significant agitation * Ongoing use of any cannabinoid-related products. This includes any THC or CBD based products, regardless of administration method (oral, inhalation, topical, etc…) Rationale 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Baycrest Hospital, University of Toronto
Toronto, Ontario, M6A2E1, Canada
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Brain and Mind Institute, University of Western Ontario
London, Ontario, 2P6H+GJ, Canada
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CHU de Québec, Université Laval
Laval, Quebec, G1V0A6, Canada
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Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N3M5, Canada
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The Douglas Research Centre
Montreal, Quebec, H4H1R3, Canada
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University of British Columbia, St Paul's Hospital
Vancouver, British Columbia, V6Z1Y6, Canada
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Western Hospital - University of Toronto
Toronto, Ontario, MH3V+9R, Canada
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