Using nabilone to treat agitation in Alzheimer's patients
Nabilone for Agitation Blinded Intervention Trial
This study is testing if nabilone can help reduce agitation in people with Alzheimer's disease to improve their overall well-being.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 112 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 6 sites (Calgary, Alberta and 5 other locations) |
| Trial ID | NCT04516057 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 55 and older with a diagnosis of Alzheimer's disease and clinically significant agitation.
Not a fit: Patients with recent changes in psychotropic medications or contraindications to nabilone may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a safer and more effective option for managing agitation in Alzheimer's patients.
How similar studies have performed: Previous pilot studies have shown preliminary evidence of nabilone's safety and efficacy in this patient population, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Calgary, Alberta and 5 other locations
- 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)
- St. Michael's Hospital — Toronto, Ontario, Canada (Recruiting)
- Ontario Shores Centre for Mental Health Sciences — Whitby, Ontario, Canada (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.