Cannabidiol Medication Intervention 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.
| Condition(s) | Alzheimer Disease |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: 1. 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 2. Di |
| Ages | 55 Years |
| Sex | All |
| Lead sponsor | Sunnybrook Health Sciences Centre |
| Locations | Calgary, Alberta, Canada; London, Ontario, Canada; Toronto, Ontario, Canada; Toronto, Ontario, Canada; Whitby, Ontario, Canada |
| Start date | 2023-09-27 |
| NCT ID | NCT06014424 |
| Official listing | https://clinicaltrials.gov/study/NCT06014424 |