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Cannabinoid

Cannabinoid Medication for Alzheimer's Disease (CALM-IT Trial)

Phase 2
Recruiting
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Presence of clinically significant agitation based on the IPA definition at both screening and baseline
Be older than 18 years old
Must not have
QT Interval Corrected Using Fridericia's Formula > 450 ms (confirmed by 2 consecutive electrocardiograms (ECGs) or a history of additional risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
Presence of clinically significant impaired renal function at screening, as evidenced by an estimated creatinine clearance < 30 mL/min/1.73 m2 (as calculated by the glomerular filtration rate using the Modification of Diet in Renal Disease study equation)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (0 weeks) to 22 weeks

Summary

This trial tests a drug to help manage agitation in people with Alzheimer's Disease, and to find biomarkers for agitation and response to treatment.

Who is the study for?
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.
What is being tested?
The CALM-IT study tests JZP541 against a placebo in managing Alzheimer's-related agitation. It's randomized and double-blind, meaning neither the researchers nor participants know who gets the real medicine versus the placebo during the trial.
What are the potential side effects?
While specific side effects are not listed here, cannabinoid medications like JZP541 can sometimes cause dizziness, dry mouth, changes in appetite or mood swings. Side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with significant agitation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My heart's electrical activity (QT interval) is longer than normal or I have risk factors for a specific heart rhythm problem.
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My kidney function is significantly impaired.
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I experience strong delusions or hallucinations.
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My blood pressure is within the normal range and doesn't drop significantly when I stand up.
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I do not have uncontrolled heart or blood vessel problems.
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I haven't changed my mental health medications recently.
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I am not allergic to cannabis or its products and do not have drug interactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (0 weeks) to 22 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (0 weeks) to 22 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Agitation - Cohen-Mansfield Agitation Inventory (CMAI)
Secondary study objectives
Behavior - Neuropsychiatric Inventory - Clinician Scale (NPI-C Agitation/NPI-NH)
Cognition - Standardized Mini-Mental State Examination (sMMSE)
Global Change - Alzheimer's Disease Cooperative Study - Clinical Global Impression of Severity/Change (ADCS-CGIS/C)
+3 more
Other study objectives
Sedation - Udvalg for Kliniske Undersøgelser (UKU) Side-Effect Rating Scale

Trial Design

2Treatment groups
Experimental Treatment
Group I: PlaceboExperimental Treatment1 Intervention
Participants randomized to the placebo will be titrated up to a maximum dose of 800 mg/day
Group II: CBDExperimental Treatment1 Intervention
Participants randomized to the CBD arm will be titrated up to a maximum dose of 800 mg/day
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CBD
2016
Completed Phase 2
~530

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
674 Previous Clinical Trials
1,565,815 Total Patients Enrolled
~26 spots leftby Dec 2026
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