Actively Recruiting
Cannabidiol Medication Intervention Trial
Led by Sunnybrook Health Sciences Centre · Updated on 2026-01-29
40
Participants Needed
5
Research Sites
169 weeks
Total Duration
On this page
Sponsors
S
Sunnybrook Health Sciences Centre
Lead Sponsor
W
Weston Brain Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
CALM-IT is a Randomized, double-blind, placebo-controlled cross-over clinical trial. Safety and efficacy of cannabidiol (CBD) capsules assessed for managing agitation in patients with AD and to identify novel biomarkers of agitation severity and treatment response.
CONDITIONS
Official Title
Cannabidiol Medication Intervention Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females aged 55 years or older; females must be post-menopausal or agree to contraception requirements, and males must comply with contraception when applicable
- Diagnosis of Major Neurocognitive Disorder due to possible Alzheimer's disease, including mixed AD and vascular causes
- Standardized Mini-Mental State Examination (sMMSE) score of 24 or lower
- Clinically significant agitation based on IPA definition at screening and baseline
- Stable dose of cognitive-enhancing medications (cholinesterase inhibitors and/or memantine) for at least 3 months before randomization
- Availability of a primary caregiver proficient in English who spends at least 10 hours weekly with the participant and can attend study visits
- Ability to give informed consent or have a Substitute Decision Maker provide consent
You will not qualify if you...
- Recent changes in psychotropic medications less than 5 half-lives before screening or any changes during study participation
- Allergies or contraindications to cannabis or cannabinoid products, or potential drug interactions with strong CYP3A4 inducers/inhibitors or anticonvulsants
- Presence of vascular disease, clinically important cerebrovascular disease, or uncontrolled cardiovascular disease
- Significant liver disease indicated by elevated liver enzymes or bilirubin
- Significant impaired kidney function
- Current major depressive episode, substance dependence (excluding caffeine and nicotine), or history of major psychiatric or neurological disorders
- Clinically significant delusions or hallucinations
- Use of marijuana or cannabinoid-based products within 1 week before randomization
- Abnormal blood pressure readings at screening or baseline, including postural drops
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
University of Calgary
Calgary, Alberta, Canada, T2N 4N1
Actively Recruiting
2
London Health Sciences Centre
London, Ontario, Canada
Actively Recruiting
3
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M3H0A7
Actively Recruiting
4
Centre for Addiction and Mental Health
Toronto, Ontario, Canada
Actively Recruiting
5
Ontario Shores Centre for Mental Health Sciences
Whitby, Ontario, Canada, L1N 5S9
Actively Recruiting
Research Team
C
CALM-IT Coordinating Centre
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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