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Nabilone-FTD

RecruitingPhase 2

Nabilone for Agitation in Frontotemporal Dementia

Double Blind Crossover Clinical Trial of Nabilone for Agitation in Frontotemporal Dementia

Lead sponsor

Simon Ducharme, MD

Asset

Nabilone

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Frontotemporal dementia

Key I/E criterion

•Age ≥18

Primary endpoint

•Cohen Mansfield Agitation Inventory (CMAI)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDNabilone-FTD

NCT IDNCT05742698

Timeline

Milestones

Study first posted2023-02-24actual

Study start2023-03-07actual

Last update posted2025-04-15actual

Primary completion2026-04estimated (month precision)

Study completion2026-05estimated (month precision)

Assets

Drug assets

Nabilone

Study populations

Who this study enrolls

Frontotemporal dementia

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Behavior / neuropsychiatric

Other (unclassified)

Behavior / neuropsychiatric

3 endpoints

Primary/protocol endpoint

Cohen Mansfield Agitation Inventory (CMAI)

Time frame:The patients CMAI score will be compared between their Baseline Assessment (prior to starting treatment) and the outcome Assessment (after 6 weeks of treatment) to determine whether agitation has changed across the treatment period.

categorical status, descriptive

Secondary/protocol endpoint

Tumor necrosis factor alpha (TNFα)

Time frame:Is TNFα associated with CMAI scores at baseline or with change in CMAI scores after 6-weeks of nabilone treatment (i.e. between Baseline and Outcome Assessments)?

descriptive

Secondary/protocol endpoint

4-hydroxynonenal (4-HNE)

Time frame:Is 4-HNE associated with CMAI scores at baseline or with change in CMAI scores after 6-weeks of nabilone treatment (i.e. between Baseline and Outcome Assessments)?

descriptive

Other (unclassified)

1 endpoint

Other/protocol endpoint/low confidence

Adverse drug reaction (ADR) to varying doses of nabilone

Time frame:Count the number of adverse drug reactions that occur accross the 6 week nabiolne treatment period to determine how well this medication is tolerated in this patient population.

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.