Status:
RECRUITING
Nabilone for Agitation Blinded Intervention Trial
Lead Sponsor:
Sunnybrook Health Sciences Centre
Collaborating Sponsors:
Alzheimer's Drug Discovery Foundation
Conditions:
Alzheimer Disease
Agitation
Eligibility:
All Genders
55+ years
Phase:
PHASE3
Brief Summary
This study will look at whether nabilone is an effective treatment for agitation in Alzheimer's disease (AD) patients. Agitation is highly prevalent in patients with AD and is one of the most distress...
Eligibility Criteria
Inclusion
- Males or females ≥55 years of age; females must be post-menopausal
- 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
- sMMSE ≤24
- Presence of clinically significant agitation based on the IPA definition
- If treated with cognitive-enhancing medications (cholinesterase inhibitors and/or memantine), dosage must be stable for at least 3 months prior to study randomization
- 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
- Change in psychotropic medications less than 1 week prior to study randomization (e.g., concomitant antidepressants)
- Contraindications to cannabinoids, e.g. allergies to cannabis and cannabis products, potential clinically important drug-drug interactions
- Current uncontrolled cardiovascular disease (e.g. uncontrolled hypertension, ischemic heart disease, arrhythmia and severe heart failure), as per investigator assessment
- Current significant liver disease, as per investigator assessment
- Presence or history of other psychiatric disorders or neurological conditions (e.g. psychotic disorders, schizophrenia, stroke, epilepsy)
- Participants currently meeting DSM 5 criteria for Major Depressive Episode (MDE)
- Previous or current abuse of/dependence on marijuana
- Clinically significant delusions and/or hallucinations (NPI-NH delusion/hallucinations subscore ≥4)
- Reported recreational use of marijuana or other cannabis products within 3 months prior to study randomization
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT04516057
Start Date
February 1 2021
End Date
October 1 2025
Last Update
April 27 2025
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Calgary
Calgary, Alberta, Canada, T2N 4N1
2
London Health Sciences Centre
London, Ontario, Canada, N6A 5W9
3
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
4
Centre for Addiction and Mental Health
Toronto, Ontario, Canada