What is the study about?
This study will look at nabilone as a treatment for agitation in persons with Alzheimer’s disease (AD). Nabilone is approved by Health Canada for managing severe nausea and vomiting in patients receiving chemotherapy. It is a medication based on one substance in cannabis (marijuana). An earlier study with a smaller group of participants found that nabilone improved agitation, behavioural symptoms, and caregiver distress. NAB-IT is a phase III trial that will include more participants.
Participants in this study will randomly be assigned to receive either nabilone 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. Participants will also be followed for 8 weeks following completion of the study treatment.
Eligibility–Who can participate?
- Be 55 years of age or older
- Have a diagnosis of Alzheimer’s disease
- Have agitation
- Have a caregiver to accompany them to study visits and participate in the study
9 visits approximately every 2 weeks. Many of the study assessments can be completed remotely.
Dr. Krista Lanctôt
Centre for Addiction and Mental Health (CAMH)
Address: 1001 Queen St W, Toronto, ON M6J 1H4Ontario Shores Centre for Mental Health Sciences
Address: 700 Gordon St, Whitby, ON L1N 5S9St. Michael’s Hospital
Address: 209 Victoria St, Toronto, ON M5B 1T8Sunnybrook Health Sciences Centre