Cannabidiol Medication Intervention Trial

ConditionAlzheimer Disease

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age55+

SponsorSunnybrook Health Sciences Centre

About 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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Contraindications to CBs, e.g. allergies to cannabis and cannabis products, potential clinically important drug-drug interactions (e.g. strong CYP3A4 inducers/inhibitors, anticonvulsants)

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

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

Trial design

Treatments tested in this trial

CBD
Placebo

Treatment groups

40 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Sunnybrook Health Sciences Centre

Lead sponsor

Weston Brain Institute

Collaborator

Source ClinicalTrials.gov