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New treatment option for Alzheimer Disease
Official title Nabilone for Agitation Blinded Intervention Trial
ClinicalTrials.gov ID: NCT04516057
What this study is testing
What is Nabilone?
Nabilone is an investigational medicine, being studied as a potential treatment for alzheimer disease.
Also referred to as Cesamet.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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...
- 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)
See the full eligibility criteria
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Calgary, Alberta, Canada
- London, Ontario, Canada
- Toronto, Ontario, Canada
- Whitby, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Calgary, Alberta, Canada; London, Ontario, Canada; Toronto, Ontario, Canada; Whitby, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.