Nabilone for Agitation in Alzheimer's Disease
(NAB-IT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This study will look at whether nabilone is an effective treatment for agitation in Alzheimer's disease (AD) patients. Agitation is highly prevalent in patients with AD and is one of the most distressing and challenging-to-treat symptoms. Agitation is associated with faster progression to institutionalization, increased caregiver burden, poorer quality of life, and increased risk of death. In addition, current pharmacological options show only modest efficacy and elevated risks of adverse events. Therefore, identifying safer and more effective treatments for agitation in AD is a clinical and research priority.Nabilone is a synthetic cannabinoid that is Health Canada-approved to treat chemotherapy-induced nausea and vomiting.The PI's research group completed a 6-week double-blind placebo-controlled randomized cross-over pilot trial in 38 patients with moderate-to-severe AD, providing the first preliminary evidence regarding the safety and efficacy of nabilone in this population. They found that nabilone significantly improved agitation, overall neuropsychiatric symptoms, and caregiver distress. That study was limited by its sample size and questions remain regarding the efficacy of nabilone for nutrition and pain and predictors of response. However, the promising preliminary findings encourage a pivotal, practice-changing phase III trial to inform clinical practice.Participants in this study will be randomized to receive either nabilone or a placebo for 8 weeks. In addition to looking at the effectiveness of nabilone in treating agitation, the researchers will also look at whether it is beneficial for other relevant outcomes for patients with AD including overall neuropsychiatric symptoms, caregiver distress, cognition, nutritional status, and pain. Participants will also be followed for 8 weeks following completion of the study treatment.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop all current medications, but if you are taking cognitive-enhancing medications, your dosage must be stable for at least 3 months before joining. Also, you should not have changed any psychotropic medications within 1 week before starting the trial.
Is nabilone generally safe for human use?
Nabilone has been studied for its safety in treating agitation in Alzheimer's disease and severe nausea from cancer chemotherapy. While it can be effective, it often causes side effects like drowsiness, dizziness, and vertigo in 60-70% of patients, and more serious effects like low blood pressure and vision problems may occur, leading to discontinuation in some cases.12345
How does the drug nabilone differ from other treatments for agitation in Alzheimer's disease?
Nabilone is unique because it is a synthetic cannabinoid that may offer a safer and more effective treatment for agitation in Alzheimer's disease, with potential benefits for weight and pain management, and possible neuroprotective effects, unlike traditional medications whose safety profiles are often questionable.14567
What data supports the effectiveness of the drug nabilone for treating agitation in Alzheimer's disease?
Who Is on the Research Team?
Krista L. Lanctot, PhD
Principal Investigator
Sunnybrook Research Institute
Giovanni Marotta, MD
Principal Investigator
Sunnybrook Health Sciences Centre
Are You a Good Fit for This Trial?
This trial is for men and women over 55 with Alzheimer's who experience significant agitation. Women must be post-menopausal, and participants should have a stable dose of cognitive-enhancing meds for at least 3 months. They need a caregiver who speaks English well. People using cannabis recently, on certain drugs, or with uncontrolled heart disease or liver issues can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to receive either nabilone or a placebo for 8 weeks to assess the effectiveness of nabilone in treating agitation and other outcomes in Alzheimer's disease patients.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion.
What Are the Treatments Tested in This Trial?
Interventions
- Nabilone
- Placebo
Nabilone is already approved in United States, Canada, United Kingdom for the following indications:
- Chemotherapy-induced nausea and vomiting
- Chemotherapy-induced nausea and vomiting
- Chemotherapy-induced nausea and vomiting
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sunnybrook Health Sciences Centre
Lead Sponsor
Alzheimer's Drug Discovery Foundation
Collaborator
Weston Brain Institute
Collaborator