Can a Cannabis-Like drug soothe Alzheimer's agitation?
NCT ID NCT04516057
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether nabilone, a synthetic cannabinoid, can safely reduce agitation in people with Alzheimer's disease. Agitation is common and distressing, with few good treatment options. About 112 participants will receive either nabilone or a placebo for 8 weeks, and researchers will track changes in agitation, behavior, and caregiver stress.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 112 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2021
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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55 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Centre for Addiction and Mental Health
RECRUITINGToronto, Ontario, Canada
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London Health Sciences Centre
RECRUITINGLondon, Ontario, N6A 5W9, Canada
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Ontario Shores Centre for Mental Health Sciences
RECRUITINGWhitby, Ontario, L1N 5S9, Canada
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St. Michael's Hospital
RECRUITINGToronto, Ontario, Canada
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Sunnybrook Health Sciences Centre
RECRUITINGToronto, Ontario, M4N 3M5, Canada
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University of Calgary
RECRUITINGCalgary, Alberta, T2N 4N1, Canada
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