Brain Sciences
Current Projects
CALM-IT
CALM-IT - CAnnabinoid Liquid Medication Intervention Trial
Principal investigators
Dr. Krista Lanctôt, PhD, Sunnybrook Health Sciences Centre
Summary
The CALM-IT trial is a randomized, double-blind, placebo-controlled cross-over clinical trial which will assess the safety and efficacy of JZP541 (a botanical cannabinoid drug) for managing agitation in patients with Alzheimer’s disease and will identify novel biomarkers of agitation severity and treatment response.
60 participants will be enrolled in this trial.
ClinicalTrials.gov (NCT#)
NCT06014424
Trial email
CALM-IT@sunnybrook.ca
Trial Locations
Toronto, ON, Canada
Oshawa, ON, Canada
Calgary, AB, Canada
NAB-IT
NAB-IT - Nabilone for Agitation Blinded Intervention Trial
Principal investigators
Dr. Krista Lanctôt, PhD, Sunnybrook Health Sciences Centre
Recruitment Status
Recruiting
Summary
NAB-IT is a randomized, double-blind, placebo-controlled clinical trial. The overall sample size of the study will be 112. Participants should have a diagnosis of Alzheimer’s disease (AD), with clinically significant agitation.
The primary objective is to assess the efficacy of nabilone in participants with AD in the treatment of agitation, as measured by the Cohen-Mansfield Agitation Inventory (CMAI), compared to placebo. Nabilone is approved by Health Canada for managing severe nausea and vomiting in patients receiving chemotherapy. It is a medication based on tetrahydrocannabinol (THC), one substance in cannabis.
Participants in this study will randomly be assigned to receive either nabilone (up to 2 mg/day) or a placebo for 9 weeks. In addition to looking at agitation, the researchers will also look at whether participants will benefit in other ways, including overall behavioural symptoms, caregiver distress, thinking and memory, nutritional status, and pain.
ClinicalTrials.gov (NCT#)
NCT04516057
Trial email
NAB-IT@Sunnybrook.ca
Trial Locations
(Toronto, ON, Canada)
(Whitby, ON, Canada)
(Calgary, AB, Canada)
The STROKE75+ Trial
The STROKE75+ Trial - An Investigator-Initiated Phase 3 Multicentre Open-Label Blinded-Endpoint Randomized Controlled Trial to Evaluate the Efficacy and Safety of Very Low-Dose Anticoagulant Therapy (Edoxaban 15 mg once daily) Added to Standard-Care Single Antiplatelet Therapy for Enhancing the Prevention of Fatal and Non-Fatal Recurrent Strokes, and Associated Disability and Dementia, in At-Risk Patients with Ischemic Stroke Aged 75 Years or Older:
Summary
Investigator-initiated multicentre open-label RCT evaluating the efficacy and safety of very low-dose anticoagulant therapy added to standard-care single antiplatelet therapy vs. single antiplatelet therapy alone for secondary stroke prevention in patients with ischemic stroke aged 75+. Sample size for the study is 1204. Primary outcome for the study is Stroke (recurrent ischemic stroke or intracerebral hemorrhage)
Principal investigators
Dr. David Gladstone, Sunnybrook Health Sciences Centre
Trial email
STROKE75Trial@sunnybrook.ca
