Tests cannabidiol capsules for agitation in people with Alzheimer disease
Tests cannabidiol capsules against a placebo for agitation in adults with Alzheimer disease.
Plain-language title generated from the registry record
Registry title: Cannabidiol Medication Intervention Trial
Key facts
- Where
- Calgary, London, Toronto, and Whitby, CanadaSee the 5 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people aged 55 or older with Alzheimer's disease who have clinically significant agitation and a caregiver who can join their visits.
- Age
- 55 years or older
- Sex
- Men and women. Women must be post-menopausal or agree to use contraception. Men must also use contraception if their partner could become pregnant.
- Disease stage
- Major neurocognitive disorder due to possible Alzheimer's disease (mixed Alzheimer's and vascular is allowed), sMMSE 24 or lower, with clinically significant agitation at screening and baseline.
- Earlier treatment
- If taking memory medicines (cholinesterase inhibitors or memantine), the dose must be stable for at least 3 months before randomization. No marijuana or cannabinoid products in the week before randomization.
Main reasons for not taking part
- Allergy to cannabis products or drug interactions with cannabidiol
- Serious heart, blood vessel or brain blood vessel disease
- Significant liver or kidney problems
- Current major depression, substance use disorder, or other major psychiatric or neurological conditions
- Significant delusions or hallucinations
Read by machine on 9 November 2026.
Where in Canada
- University Of CalgaryCalgary, CanadaTaking people
- London Health Sciences CentreLondon, CanadaTaking people
- Centre for Addiction and Mental HealthToronto, CanadaTaking people
- Sunnybrook Health Sciences CentreToronto, CanadaTaking people
- Ontario Shores Centre for Mental Health SciencesWhitby, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Sunnybrook Health Sciences Centre
- Trial code
- NCT06014424
- Record updated
- 31 July 2026
- Original description
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.Read full original descriptionShow less
Cannabidiol Medication Intervention Trial (CALM-IT)
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.
Inclusion: Males or females ≥55 years of age; female must be post-menopausal or must agree to comply with contraception requirements. Males should also abide by contraceptive requirements when the partner is a woman of childbearing potential. Acceptable methods of contraception include: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, which may be oral, intravaginal, or transdermal; progestogen-only hormonal contraception associated with inhibition of ovulation, which may be oral, injectable, or implantable; intrauterine device or intrauterine hormone-releasing system; vasectomy of a female subject's male partner (with medical assessment and confirmation of vasectomy surgical success); bilateral tubal occlusion; Diagnostic and Statistical Manual of Mental Disorders-5 (DSM 5) criteria for Major Neurocognitive Disorder due to possible AD. Patients with Major Neurocognitive Disorder due to multiple etiologies (AD and vascular) will be included; sMMSE ≤24; Presence of clinically significant agitation based on the IPA definition at both screening and baseline; If treated with cognitive-enhancing medications (cholinesterase inhibitors and/or memantine), dosage must be stable for at least 3 months prior to study randomization; Availability of a primary caregiver to accompany the participant to study visits and to participate in the study. The primary caregiver must be sufficiently proficient in English to complete the required study assessments, as per investigator judgement and should spend at least 10 hours a week with the participant; Willing and able to provide informed consent and/or have a Substitute Decision Maker (SDM) provide informed consent on behalf of the participant.
Exclusion: Change in psychotropic medications less than the duration of 5 half-lives of the medication in question prior to screening (e.g., concomitant antidepressants or atypical antipsychotics) and any changes during study participation; Vascular disease, clinically important cerebrovascular disease or current uncontrolled cardiovascular disease (e.g. uncontrolled hypertension, ischemic heart disease, arrhythmia and severe heart failure, cardiovascular accident in the 3 months prior to Screening (V1)), as per investigator assessment; Reported use of marijuana or cannabinoid-based medications, products or supplements (botanical or synthetic) within 1 week prior to randomization; Systolic blood pressure (SBP) < 90 mmHg or > 150 mmHg or diastolic blood pressure (DBP) < 50mmHg or > 105 mmHg at screening or baseline (prior to randomization) or a postural drop in SBP ≥ 20 mmHg or DBP ≥ 10 mmHg at screening; Contraindications to CBs, e.g. allergies to cannabis and cannabis products, potential clinically important drug-drug interactions (e.g. strong CYP3A4 inducers/inhibitors, anticonvulsants); Currently meeting DSM 5 criteria for Major Depressive Episode Presence, or current substance dependence (excluding caffeine and nicotine) or history of other major psychiatric disorders or neurological conditions (e.g. psychotic disorders, schizophrenia, stroke, epilepsy); Substance-Related Disorders (excluding caffeine and nicotine); Clinically significant liver disease, as reflected by serum alanine aminotransferase or aspartate aminotransferase > 2 x upper limit of normal (ULN), or total bilirubin > 1.5 x ULN; The Investigator may decide to repeat the assessment to confirm criterion prior to screen failing the participant; Clinically significant impaired renal function at screening, as per investigator assessment; Clinically significant delusions and/or hallucinations (e.g. NPI-NH delusion/hallucinations subscore ≥4 or judgement of QI).