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Nabilone for Agitation Blinded Intervention Trial

RecruitingPhase 3Ages 55 Years - anyAllSunnybrook Health Sciences Centre
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In plain words

What the trial is, and whether it could suit you

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 distressing and challenging-to-treat symptoms. Agitation is associated with faster progression to institutionalization, increased caregiver burden, poorer quality of life, and increased risk of death. In addition, current pharmacological options show only modest efficacy and elevated risks of adverse events. Therefore, identifying safer and more effective treatments for agitation in AD is a clinical and research priority. Nabilone is a synthetic cannabinoid that is Health Canada-approved to treat chemotherapy-induced nausea and vomiting. The PI's research group completed a 6-week double-blind placebo-controlled randomized cross-over pilot trial in 38 patients with moderate-to-severe AD, providing

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Males or females โ‰ฅ55 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 โ‰ค24 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 โ‰ฅ4) 9. Reported recreational use of marijuana or other cannabis products within 3 months prior to study randomization
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What it tests

  • Nabilone
  • Placebo
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Where

6 sites
University of Calgary
Calgary, Canada
London Health Sciences Centre
London, Canada
Sunnybrook Health Sciences Centre
Toronto, Canada
Centre for Addiction and Mental Health
Toronto, Canada
St. Michael's Hospital
Toronto, Canada
Ontario Shores Centre for Mental Health Sciences
Whitby, Canada
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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