Nabilone for Agitation Blinded Intervention Trial (NAB-IT)
Alzheimer's DiseaseAgitation is common in patients with Alzheimer's Disease (AD) and is one of the most distressing and symptoms of AD. Agitation is associated with faster loss of independent living, increased caregiver stress, poorer quality of life, and increased risk of death. In addition, current treatments show only mild benefits but come with side effects. Therefore, identifying safer and more effective treatments for agitation in AD is a priority.
This study will look at whether nabilone is an effective treatment for agitation in AD patients. Nabilone is a manufactured cannabinoid (a medication based on one substance in cannabis) that is Health Canada approved. It is used to treat nausea and vomiting in cancer patients.
Participants in this study will receive either nabilone or a placebo for 8 weeks. The researchers will for improvement in agitation. They will also look for improvement in mental health symptoms, caregiver stress, memory and thinking, nutritional status, and pain.
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Participation Requirements
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Sex:
Male, Female, Intersex -
Eligible Ages:
55 and up
Participation Criteria
Inclusion Criteria:
1. Diagnosis of Alzheimer's disease
2. Significant agitation
3. 55 years or older
4. Availability of a caregiver that can participate along with the participant
Exclusion Criteria:
1. Previous or current abuse of/dependence on marijuana
2. Contraindications to cannabinoids
3. Current reported recreational use of marijuana or other cannabis products
Study Location
University of Calgary
University of CalgaryCalgary, Alberta
Canada
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St. Michael's Hospital
St. Michael's HospitalToronto, Ontario
Canada
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Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences CentreToronto, Ontario
Canada
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Centre for Addiction and Mental Health
Centre for Addiction and Mental HealthToronto, Ontario
Canada
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London Health Sciences Centre
London Health Sciences CentreLondon, Ontario
Canada
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Ontario Shores Centre for Mental Health Sciences
Ontario Shores Centre for Mental Health SciencesWhitby, Ontario
Canada
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University of Calgary
University of CalgaryCalgary, Alberta
Canada
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- Study Sponsored By
- Sunnybrook Health Sciences Centre
- Participants Required
- More Information
- Study ID:
NCT04516057