Using Cannabidiol (CBD) to treat agitation in Alzheimer’s disease
Full study title: CAnnabidioL Medication Intervention Trial (CALM-IT)
What is the study about?
This study will test how safe and effective cannabidiol (CBD) is in treating agitation in persons with Alzheimer’s disease (AD). Previously, another medication called nabilone (based on another substance in the cannabis plant) was shown to be effective for treating agitation in AD. This study is testing if CBD, made up of a different chemical material from the cannabis (marijuana) plant, can be used to treat agitation. The study will have two phases during which participants will receive either the CBD medication first or a non-active treatment (i.e. placebo) first, and the order of these treatments will then be reversed in the second phase of the study. This study will look at how CBD helps with agitation, overall behavioural symptoms, caregiver difficulties, thinking and memory, nutritional status, and pain.
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
The total study period is 23 weeks.
There will be two 9-week treatment phases (CBD and placebo), and a follow-up visit one month from the last treatment visit. CBD and placebo will be in the form of oral pills.
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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).