Nabilone for Agitation Blinded Intervention Trial (NAB-IT)
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?
Participants must:
- 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
Time requirement:
9 visits approximately every 2 weeks. Many of the study assessments can be completed remotely.
Study Video
Advances in Dementia Research Webinar- Listen to Dr. Krista L. Lanctôt (Principal Investigator) discuss the NAB-IT study in further detail:
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Disclaimer
The listing of a study on the TDRA’s Research Studies Portal is for informational purposes only. The safety, efficacy or scientific validity of the studies listed here have not been evaluated by The Alzheimer Society of Toronto (AST) or the Toronto Dementia Research Alliance (TDRA). The TDRA is an academic coalition among the University of Toronto and Baycrest, the Centre for Addiction and Mental Health, Ontario Shores Centre for Mental Health Sciences, Sunnybrook Health Sciences Centre, and the University Health Network. The information collected will be kept and guarded by TDRA. Choosing to participate in a study is an important personal decision. Before you participate in a study, you should make sure you understand the risks and potential benefits and discuss all options with your health care provider(s).