Using nabilone to treat agitation in Alzheimer's patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of nabilone, a synthetic cannabinoid, in reducing agitation among patients with Alzheimer's disease. Agitation is a common and distressing symptom in these patients, often leading to increased caregiver burden and a decline in quality of life. The study will involve a randomized, double-blind, placebo-controlled design to assess the safety and efficacy of nabilone compared to a placebo. Participants will be monitored for changes in agitation levels and overall well-being throughout the trial.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Males or females ≥55 years of age; females must be post-menopausal
2. Diagnostic and Statistical Manual of Mental Disorders-5 (DSM 5) criteria for Major Neurocognitive Disorder due to AD. Patients with Major Neurocognitive Disorder due to multiple etiologies (AD and vascular) will be included
3. sMMSE ≤24
4. Presence of clinically significant agitation based on the IPA definition
5. If treated with cognitive-enhancing medications (cholinesterase inhibitors and/or memantine), dosage must be stable for at least 3 months prior to study randomization
6. Availability of a primary caregiver to accompany the participant to study visits and to participate in the study. The primary caregiver must be sufficiently proficient in English to complete the required study assessments, as per investigator judgement.

Exclusion Criteria:

1. Change in psychotropic medications less than 1 week prior to study randomization (e.g., concomitant antidepressants)
2. Contraindications to cannabinoids, e.g. allergies to cannabis and cannabis products, potential clinically important drug-drug interactions
3. Current uncontrolled cardiovascular disease (e.g. uncontrolled hypertension, ischemic heart disease, arrhythmia and severe heart failure), as per investigator assessment
4. Current significant liver disease, as per investigator assessment
5. Presence or history of other psychiatric disorders or neurological conditions (e.g. psychotic disorders, schizophrenia, stroke, epilepsy)
6. Participants currently meeting DSM 5 criteria for Major Depressive Episode (MDE)
7. Previous or current abuse of/dependence on marijuana
8. Clinically significant delusions and/or hallucinations (NPI-NH delusion/hallucinations subscore ≥4)
9. Reported recreational use of marijuana or other cannabis products within 3 months prior to study randomization

Where it's running

• University of Calgary
  Calgary, Alberta, Canada Recruiting
• London Health Sciences Centre
  London, Ontario, Canada Recruiting
• Sunnybrook Health Sciences Centre
  Toronto, Ontario, Canada Recruiting
• Centre for Addiction and Mental Health
  Toronto, Ontario, Canada Recruiting
• Ontario Shores Centre for Mental Health Sciences
  Whitby, Ontario, Canada Recruiting
• Geras Centre for Aging Research, Hamilton Health Sciences
  Hamilton, Ontario, Canada Not yet recruiting

Study contacts

• Principal investigator: Krista L. Lanctot, PhD — Sunnybrook Research Institute
• Study coordinator: NAB-IT Coordinating Centre
• Email: NAB-IT@sunnybrook.ca
• Phone: 416-480-6100

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.