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Can a synthetic cannabinoid calm agitation in frontotemporal dementia?

NCT ID NCT05742698

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

3 people

The number who actually took part.

Started

Mar 2023

Finished

Dec 2025

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

  • Baycrest Hospital, University of Toronto

    Toronto, Ontario, M6A2E1, Canada

  • Brain and Mind Institute, University of Western Ontario

    London, Ontario, 2P6H+GJ, Canada

  • CHU de Québec, Université Laval

    Laval, Quebec, G1V0A6, Canada

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N3M5, Canada

  • The Douglas Research Centre

    Montreal, Quebec, H4H1R3, Canada

  • University of British Columbia, St Paul's Hospital

    Vancouver, British Columbia, V6Z1Y6, Canada

  • Western Hospital - University of Toronto

    Toronto, Ontario, MH3V+9R, Canada

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