Nabilone for Agitation Blinded Intervention 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, increase
| Condition(s) | Alzheimer Disease, Agitation |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | 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- |
| Who can participate | Inclusion Criteria: 1. Males or females ≥55 years of age; females must be post-menopausal 2. Diagnostic and Statistical Manual of Mental Disorders-5 (DSM 5) criteria for Major Neurocognitive Disorder due to AD. Patients with Major Neurocognitive Disorder due to multiple etiologies (AD and vascular) will be included 3. sMMSE ≤24 4. Presence of clinically significant agitation based on the IPA definition 5. If treated with cognitive-enhancing medications (cholinesterase inhibitors and/or memantine), dosage must be stable for at least 3 months prior to study randomization 6. Availability of a primary caregiver to accompany the participant to study visits and to participate in the study. The primary caregiver must be sufficiently proficient in English to complete the required study assessments |
| Ages | 55 Years |
| Sex | All |
| Lead sponsor | Sunnybrook Health Sciences Centre |
| Locations | Calgary, Alberta, Canada; London, Ontario, Canada; Toronto, Ontario, Canada; Toronto, Ontario, Canada; Toronto, Ontario, Canada; Whitby, Ontario, Canada |
| Start date | 2021-02-01 |
| NCT ID | NCT04516057 |
| Official listing | https://clinicaltrials.gov/study/NCT04516057 |