Actively Recruiting
Double Blind Crossover Clinical Trial of Nabilone for Agitation in Frontotemporal Dementia
Led by Simon Ducharme, MD · Updated on 2025-04-15
45
Participants Needed
7
Research Sites
4 weeks
Total Duration
On this page
Sponsors
S
Simon Ducharme, MD
Lead Sponsor
A
Alzheimer's Drug Discovery Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether oral nabilone can reduce agitation compared with a placebo in patients with frontotemporal dementia (FTD), including the behavioral variant and primary progressive aphasia. This study addresses the common and challenging neuropsychiatric symptoms of FTD such as agitation, irritability, and aggression, which currently have limited effective treatment options. Nabilone, a synthetic cannabinoid, has shown promise in Alzheimer's disease and may impact mechanisms related to FTD symptoms. Participants will receive nabilone or placebo in a double-blind, randomized crossover design. For the first two weeks, patients take one capsule daily before bedtime, increasing to two capsules daily in weeks three and four, and up to four capsules daily in weeks five and six if symptoms persist without adverse effects. Assessments occur remotely or in person at two interim points to evaluate symptom changes and adjust dosing. The placebo capsules match the nabilone capsules closely to maintain blinding. Throughout the six-week treatment periods, patients and their study partners complete evaluations including the Cohen Mansfield Agitation Inventory (CMAI) to measure changes in agitation. Blood samples will be analyzed for inflammatory markers related to symptom changes. Safety monitoring includes checking for side effects and tolerability. The involvement of study partners helps provide accurate symptom reports. Total participation time includes screening, treatment, and follow-up assessments to ensure comprehensive data collection.
CONDITIONS
Brief Title
Nabilone for Agitation in Frontotemporal Dementia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women over 18 years
- Diagnosed with probable behavioral variant frontotemporal dementia or primary progressive aphasia
- Meet International Psychogeriatric Association criteria for agitation in cognitive disorders
- Cohen Mansfield Agitation Inventory (CMAI) score of 39 or above
- Stable psychoactive medication for at least 2 weeks before screening with no planned dose changes
- Have a study partner with at least 10 hours per week in-person contact
- Able to provide written consent or have a surrogate decision maker consent if incapacitated
You will not qualify if you...
- Clinically significant psychotic symptoms (severity and frequency score of 4 or higher for delusions or hallucinations)
- Clinically significant orthostatic hypotension or symptomatic orthostatic tachycardia
- Unstable cardiovascular condition
- History of drug or alcohol dependence or abuse in the past 12 months
- Allergy or significant adverse reaction to cannabinoids, especially with psychosis or severe anxiety
- Major depressive episode within 6 months prior to screening
- Women who are pregnant or breastfeeding
- Severe liver dysfunction
- Other psychiatric or neurological conditions causing significant agitation
- Current use of any cannabinoid-related products including THC or CBD forms orally, inhaled, or topical
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Duration - 6 weeks per treatment period
Participants receive nabilone or placebo in a crossover design to evaluate effects on agitation symptoms in frontotemporal dementia. Dosage may increase over time if remission is not achieved and no adverse reactions occur.
3 assessments (in-person or remote) including baseline, interim at 2 weeks, and interim at 4 weeks
Trial Site Locations
Total: 7 locations
1
University of British Columbia, St Paul's Hospital
Vancouver, British Columbia, Canada, V6Z1Y6
Actively Recruiting
2
Brain and Mind Institute, University of Western Ontario
London, Ontario, Canada, 2P6H+GJ
Not Yet Recruiting
3
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N3M5
Actively Recruiting
4
Baycrest Hospital, University of Toronto
Toronto, Ontario, Canada, M6A2E1
Active, Not Recruiting
5
Western Hospital - University of Toronto
Toronto, Ontario, Canada, MH3V+9R
Actively Recruiting
6
CHU de Québec, Université Laval
Laval, Quebec, Canada, G1V0A6
Actively Recruiting
7
The Douglas Research Centre
Montreal, Quebec, Canada, H4H1R3
Actively Recruiting
Research Team
S
Simon Ducharme, MD, MA
A
Ahmad Fakhoury, MA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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