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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (0 weeks) to 22 weeks

Awards & highlights

CALM-IT Trial 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.Check my eligibility

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.See study design

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.

CALM-IT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with significant agitation.

CALM-IT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (0 weeks) to 22 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Agitation - Cohen-Mansfield Agitation Inventory (CMAI)

Secondary outcome measures

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 outcome measures

Sedation - Udvalg for Kliniske Undersøgelser (UKU) Side-Effect Rating Scale

CALM-IT 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

~460

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor

656 Previous Clinical Trials

1,551,268 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any potential risks associated with using JZP541?

"Our team has assigned JZP541 a safety rating of 2, since this is a Phase 2 trial and there's only supportive evidence for the drug’s security but none on its effectiveness."

Answered by AI

Are there openings available for the public to participate in this experiment?

"According to clinicaltrials.gov, this particular medical study is not actively recruiting participants at present. Initially posted on September 20th of 2023 and most recently updated on the 11th of same month, there are nevertheless 544 other studies for which volunteers can apply presently."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cannabidiol Medication Intervention Trial

2023. "Cannabidiol Medication Intervention Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06014424.