Nabilone for Agitation Blinded Intervention Trial

Launched by SUNNYBROOK HEALTH SCIENCES CENTRE · Aug 14, 2020

Keywords

ClinConnect Summary

This clinical trial is studying whether a medication called nabilone can help reduce agitation in people with Alzheimer's disease (AD). Agitation is a common and difficult-to-treat symptom in AD that can make life harder for both patients and their caregivers. Nabilone is a synthetic form of cannabis that is already used to help patients undergoing chemotherapy. The researchers want to see if it can also improve agitation and other related issues, like overall mental health, caregiver stress, and even pain and nutrition in patients with AD.

To participate in this study, individuals need to be at least 55 years old, diagnosed with Alzheimer's disease, and experiencing significant agitation. Participants will be randomly assigned to receive either nabilone or a placebo (a harmless pill with no active ingredients) for eight weeks. They will also have follow-up visits for an additional eight weeks after treatment. It's important for participants to have a caregiver who can help with visits and assessments. This trial is currently recruiting, and it represents a significant step towards finding safer and more effective treatments for agitation in Alzheimer's patients.

Gender

ALL

Eligibility criteria

• 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