Using nabilone to reduce agitation in frontotemporal dementia

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

This study is testing if a medication called nabilone can help reduce agitation in adults with frontotemporal dementia.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Douglas Mental Health University Institute (other)
• Locations: 7 sites (Vancouver, British Columbia and 6 other locations)
• Trial ID: NCT05742698 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of oral nabilone in reducing agitation in patients diagnosed with frontotemporal dementia, including both the behavioral variant and primary progressive aphasia. Participants will be compared to a placebo group to assess the impact of nabilone on neuropsychiatric symptoms associated with these conditions. The study will include adults over 18 years who meet specific diagnostic criteria and have a stable medication regimen. The goal is to provide a new treatment option for managing severe agitation, which is often inadequately addressed by current pharmacological therapies.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with probable behavioral variant frontotemporal dementia or primary progressive aphasia who exhibit significant agitation.

Not a fit: Patients with other types of dementia or those not exhibiting agitation may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients with frontotemporal dementia and reduce caregiver burden.

How similar studies have performed: While there is limited evidence on the use of nabilone for this specific condition, other studies have explored its potential benefits for neuropsychiatric symptoms in various disorders, indicating a novel approach.

Eligibility criteria

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.

Where this trial is running

Vancouver, British Columbia and 6 other locations

• University of British Columbia, St Paul's Hospital — Vancouver, British Columbia, Canada (RECRUITING)
• Brain and Mind Institute, University of Western Ontario — London, Ontario, Canada (NOT_YET_RECRUITING)
• Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (RECRUITING)
• Baycrest Hospital, University of Toronto — Toronto, Ontario, Canada (ACTIVE_NOT_RECRUITING)
• Western Hospital - University of Toronto — Toronto, Ontario, Canada (RECRUITING)
• CHU de Québec, Université Laval — Laval, Quebec, Canada (RECRUITING)
• The Douglas Research Centre — Montreal, Quebec, Canada (RECRUITING)

Study contacts

• Study coordinator: Simon Ducharme, MD, MA

Conditions: Frontotemporal Dementia, Frontotemporal Dementia, Behavioral Variant, Primary Progressive Aphasia, bvFTD, PPA, FTD, Nabilone, Nabilone FTD