Actively Recruiting
Nabilone for Agitation in Frontotemporal Dementia
Led by Simon Ducharme, MD · Updated on 2025-04-15
45
Participants Needed
7
Research Sites
164 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
The primary goal of this study is to test the hypothesis that oral nabilone treatment will reduce agitation compared with placebo in patients with Frontotemporal Dementia (both behavioural variant frontotemporal dementia and primary progressive aphasia). The study population is defined as patients with probable Frontotemporal Dementia that meet the International Psychogeriatric Association criteria for agitation in cognitive disorders.
CONDITIONS
Official Title
Nabilone for Agitation in Frontotemporal Dementia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women over 18 years
- Diagnosis of major neurocognitive disorder due to probable behavioral variant FTD or primary progressive aphasia
- Meets 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 during treatment
- Has a study partner with at least 10 hours per week of in-person contact
- Ability to provide written consent in English or French, or consent from a surrogate if unable to consent
You will not qualify if you...
- Significant psychotic symptoms with high severity or frequency
- Clinically significant orthostatic hypotension or symptomatic orthostatic tachycardia
- Unstable cardiovascular conditions
- History of drug or alcohol dependence or abuse in the past 12 months
- Allergy or severe adverse reaction to cannabinoids, especially with psychosis or severe anxiety
- Major depressive episode within 6 months before screening
- Women who are pregnant or breastfeeding
- Severe liver dysfunction
- Other psychiatric or neurological conditions causing significant agitation
- Current use of any cannabinoid products including THC or CBD in any form
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
A
Ahmad Fakhoury, MA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here