Randomized Placebo-Controlled Trial of Nabilone for Agitation in Alzheimer's Disease.
Nathan Herrmann, Myuri Ruthirakuhan, Damien Gallagher...
https://pubmed.ncbi.nlm.nih.gov/31182351Actively Recruiting
Phase 3
Age: 55Years +
All Genders
ID04516057
Nabilone for Agitation Blinded Intervention Trial for Alzheimer's Disease
Led by Sunnybrook Health Sciences Centre · Updated on 2026-01-28
112
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Sunnybrook Health Sciences Centre
Lead Sponsor
A
Alzheimer's Drug Discovery Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether nabilone, a synthetic cannabinoid approved for chemotherapy-related nausea, is an effective treatment for agitation in patients with Alzheimer's disease (AD). Agitation is common in AD and can worsen quality of life, increase caregiver burden, and speed institutionalization. Current treatments have limited effectiveness and notable risks, so this study aims to explore nabilone's potential benefits for agitation and other symptoms in AD. Participants will be randomly assigned to receive either nabilone or placebo capsules for 8 weeks. Those in the nabilone group will have their dose gradually increased up to a maximum of 2 mg per day. After the treatment phase, all participants will be followed for an additional 8 weeks to monitor ongoing effects. The study uses a quadruple-blind design to compare outcomes between the two groups. During the study, participants will undergo assessments of agitation using the Cohen-Mansfield Agitation Inventory, as well as evaluations of behavior, cognition, weight, nutritional status, pain, and global clinical change. Caregivers will also participate in study visits and assessments. The research team will closely monitor these factors from the start through 8 weeks after treatment ends to understand the effects and safety of nabilone in this population.
CONDITIONS
Brief Title
Nabilone for Agitation Blinded Intervention Trial
Who Can Participate
Age: 55Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Males or females 55 years of age or older; females must be post-menopausal
- Diagnosis of Major Neurocognitive Disorder due to Alzheimer's disease or mixed Alzheimer's and vascular causes
- Standardized Mini-Mental State Examination (sMMSE) score of 24 or less
- Clinically significant agitation based on the International Psychogeriatric Association (IPA) definition
- Stable dose of cognitive-enhancing medications for at least 3 months prior to randomization if used
- Availability of a primary caregiver who is proficient in English and can attend study visits
You will not qualify if you...
- Change in psychotropic medications less than 1 week before randomization
- Allergies to cannabis or contraindications to cannabinoids
- Current uncontrolled cardiovascular disease
- Current significant liver disease
- History or presence of other psychiatric or neurological disorders such as psychosis, schizophrenia, stroke, or epilepsy
- Meeting criteria for Major Depressive Episode at the time of screening
- Current or past marijuana abuse or dependence
- Significant delusions or hallucinations
- Recreational use of marijuana or cannabis products within 3 months before randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 8 weeks
Participants receive either nabilone or placebo capsules for 8 weeks.
Weekly visits for up to 8 weeks
Follow-up
Duration - 8 weeks
Participants are monitored for safety and outcomes for 8 weeks after completing the treatment.
1 to 2 visits depending on participant condition
Trial Site Locations
Total: 6 locations
1
University of Calgary
Calgary, Alberta, Canada, T2N 4N1
Actively Recruiting
2
London Health Sciences Centre
London, Ontario, Canada, N6A 5W9
Actively Recruiting
3
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
4
Centre for Addiction and Mental Health
Toronto, Ontario, Canada
Actively Recruiting
5
St. Michael's Hospital
Toronto, Ontario, Canada
Actively Recruiting
6
Ontario Shores Centre for Mental Health Sciences
Whitby, Ontario, Canada, L1N 5S9
Actively Recruiting
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Research Team
N
NAB-IT Coordinating Centre
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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