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Nabilone for Agitation Blinded Intervention Trial (NAB-IT)

Alzheimer's Disease

Agitation 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

  • 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 Calgary
Calgary, Alberta
Canada

Contact Study Team

Primary Contact

Ramnik Sekhon

[email protected]
St. Michael's Hospital
St. Michael's Hospital
Toronto, Ontario
Canada

Contact Study Team

Primary Contact

Adrienne Atayde

[email protected]
Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences Centre
Toronto, Ontario
Canada

Contact Study Team

Primary Contact

Kritleen Bawa

[email protected]
416-480-6100
Centre for Addiction and Mental Health
Centre for Addiction and Mental Health
Toronto, Ontario
Canada

Contact Study Team

Primary Contact

Salma Abdelghaffar

[email protected]
London Health Sciences Centre
London Health Sciences Centre
London, Ontario
Canada

Contact Study Team

Primary Contact

Adriana Diez

[email protected]
519-685-8500
Ontario Shores Centre for Mental Health Sciences
Ontario Shores Centre for Mental Health Sciences
Whitby, Ontario
Canada

Contact Study Team

Primary Contact

Elaina Niciforos

[email protected]
University of Calgary
University of Calgary
Calgary, Alberta
Canada

Contact Study Team

Study Sponsored By
Sunnybrook Health Sciences Centre
Participants Required
More Information
Study ID: NCT04516057