RecruitingPhase 2NCT06014424

Cannabidiol Medication Intervention Trial

Cannabidiol Medication Intervention Trial (CALM-IT)


Sponsor

Sunnybrook Health Sciences Centre

Enrollment

40 participants

Start Date

Sep 27, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether cannabidiol (CBD), a non-psychoactive compound from cannabis, can reduce agitation in people with Alzheimer's disease and major neurocognitive disorder. Agitation (including restlessness, aggression, and irritability) is one of the most distressing symptoms of Alzheimer's. **You may be eligible if...** - You are 55 or older - You have been diagnosed with major neurocognitive disorder likely due to Alzheimer's disease (or Alzheimer's combined with vascular causes) - You have significant agitation that meets established clinical criteria, present at both the screening and baseline visits - You scored 24 or below on a standard cognitive test (sMMSE ≤24) - If you take cognitive medications (e.g., donepezil, memantine), your dose has been stable for at least 3 months - You have a primary caregiver who can attend study visits and participate alongside you **You may NOT be eligible if...** - Your agitation is not clinically significant - Your caregiver is unavailable or doesn't speak English well enough - You have severe medical or psychiatric conditions that may complicate participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCBD

Participants in this arm will receive CBD for 8 weeks during the first treatment period. They will then receive a two-week single-blind placebo washout before moving into the second 8-week treatment period, during which they will receive the opposite study treatment than the one given in the first treatment period.

OTHERPlacebo

Participants in this arm will receive placebo for 8 weeks during the first treatment period. They will then receive a two-week single-blind placebo washout before moving into the second 8-week treatment period, during which they will receive the opposite study treatment than the one given in the first treatment period.


Locations(5)

University of Calgary

Calgary, Alberta, Canada

London Health Sciences Centre

London, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Centre for Addiction and Mental Health

Toronto, Ontario, Canada

Ontario Shores Centre for Mental Health Sciences

Whitby, Ontario, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06014424


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