Cannabinoid Medication for Alzheimer's Disease
(CALM-IT Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial requires that if you are taking cognitive-enhancing medications, your dosage must be stable for at least 3 months before joining. You cannot change psychotropic medications shortly before or during the trial, and you must stop using anticonvulsant medications and strong inducers of CYP3A4 at least 14 days before starting the trial.
What data supports the effectiveness of the drug JZP541 for Alzheimer's disease?
Is cannabinoid medication safe for humans?
Cannabinoid medications, including those with CBD and THC, have been studied for their safety in humans, showing potential benefits like reducing inflammation and protecting brain cells. However, more clinical studies are needed to fully understand their safety and optimal use, especially in older adults with Alzheimer's disease.678910
How is the drug JZP541 different from other Alzheimer's treatments?
What is the purpose of this trial?
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.
Research Team
Krista L. Lanctot, PhD
Principal Investigator
Sunnybrook Research Institute
Giovanni Marotta
Principal Investigator
Sunnybrook Health Sciences Centre
Eligibility Criteria
This trial is for people aged 55+ with Alzheimer's Disease who experience significant agitation. Participants must have a stable dose of cognitive-enhancing meds for 3 months, and a caregiver able to assist. They should not have certain liver issues, recent drug or alcohol dependence, uncontrolled cardiovascular disease, or be using cannabis products.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment Phase 1
Participants receive either CBD or placebo for the first treatment phase
Treatment Phase 2
Participants cross-over to the opposite treatment (CBD or placebo) for the second treatment phase
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- JZP541
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sunnybrook Health Sciences Centre
Lead Sponsor
Weston Brain Institute
Collaborator