CAnnabidioL Medication Intervention Trial (CALM-IT)

What is the study about?

This study will look at how cannabidiol (CBD) can help control symptoms of agitation in persons living with Alzheimer’s disease (AD). The CBD-based medication that will be utilized in this study is made from a substance found in the cannabis plant (marijuana). Previous studies utilized a medication based on a similar substance (called nabilone), also found in the cannabis plant. These studies concluded that people living with agitation and AD felt less agitated after taking the medication.

Participants in this study will take the CBD-based medication for 8 weeks and a placebo for 8 weeks. Participants and study staff will be blinded to which medication they will receive first. This study will take about 23 weeks to complete, and will consist of 12 in-person visits and 8 telephone visits, for each participant and caregiver team.

 

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 by answering questions about the participants’ mood and behaviour

 

Time requirement

12 study visits and 8 telephone visits over 23 weeks. Many of the study assessments can be completed remotely.

 

TDRA study investigator

Dr. Krista Lanctôt

TDRA Site:

Sunnybrook Health Sciences Centre

Address: 2075 Bayview Ave, Toronto, ON M4N 3M5

Age Group:

55 - 59, 60 - 64, 65 - 69, 70 - 75, 70 - 80, 81 - 85, 86 - 90, 91+

Target Population:

Alzheimer’s disease