Nabilone for Agitation Blinded Intervention Trial (NAB-IT)

What is this Study about?

The high prevalence and impact of agitation in moderate to severe Alzheimer’s disease (AD) makes this neuropsychiatric symptom (NPS) a key determinant of decreased quality of life. Associated with agitation are weight loss, and pain, both of which lead to additional loss of quality of life. Agitation frequently necessitates use of antipsychotics, which, while well-studied, have modest efficacy and severe side effects including increased mortality. The aim of this study is to determine whether the Δ9-tetrahydrocannabinol (THC) analogue nabilone is effective at treating agitation in Alzheimer’s disease, as well as its effect on pain, weight, and overall NPS.

What Will Happen in This Study?

The participants in this study will be expected to:

- Tell study staff about their medical conditions and all medications and supplements and any changes that may occur.

- Allow study staff to complete blood draws and administer study questionnaires.

- Take study medication as directed and return any unused study medication and diaries.

The study intervention period will last for 9 weeks. There will be two phone calls and six in-person visits.

Who is Eligible to Participate in this Study?

You are eligible to participate if you meet the following criteria:

• Age ≥ 55; females must be post-menopausal

• DSM-5 criteria for Major Neurocognitive Disorder due to AD; multiple etiologies (AD and vascular)

• sMMSE ≤ 24

• Clinically significant agitation based on IPA definition

• Stable cognition-enhancing medication for at least 3 months prior to study enrolment

• Availability of a caregiver to accompany participant to study visits and to participate in the study

• Ability to speak English

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