Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
45 participants
INTERVENTIONAL
2023-03-07
2026-05-31
Brief Summary
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Detailed Description
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One promising candidate is nabilone, a synthetic cannabinoid that has shown benefit for agitation in Alzheimer's disease. Nabilone further has potentially beneficial properties on oxidative stress and inflammation in neurodegenerative diseases, mechanisms that have been linked to the pathophysiology of FTD. We propose to conduct the first randomized clinical trial of nabilone for agitation, irritability, and aggression in FTD to obtain data on real-life effectiveness and tolerability. There is a need to obtain data on the efficacy of nabilone on a wide variety of neuropsychiatric symptoms beyond agitation in FTD, while also ensuring the safety of the medication (e.g., is there a detrimental effect on apathy and hyperorality, which are common in FTD). We require data on dosing and tolerability in this population, which is younger on average than Alzheimer's disease subjects from previous studies and therefore may tolerate higher doses of nabilone. The objective of this trial is to obtain robust evidence for the effectiveness and tolerability of nabilone in FTD.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
After consent and screening, study staff will enter disease severity into the electronic data capture system randomization module so the research pharmacist will be notified via email of study ID and disease severity. Participants will be randomly assigned to receive either Nabilone or placebo for the first treatment phase.
Study Groups
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Nabilone
Weeks 1-2 Nabilone and placebo will be taken orally by the patient as per the schedule provided by the research team. All patients will start with one 0.5mg capsule per day, taken before bed for the first week and then increase administration to the 1mg capsule taken before bed for the second week.
Weeks 3-4 Two weeks after the start of the trial patients and study partners will attend an in person or remote Interim Assessment. If remission is not achieved and no clinically significant adverse drug reactions are reported then the dose schedule will increase to 2 capsules per day (2mg/day), 1 capsule in the morning and 1 before bed.
Weeks 5-6 Four weeks after the start of the trial there will be a second in person or remote Interim Assessment identical to the first. If remission of agitation has not been achieved and no adverse drug reactions are reported the dose schedule will increase to 4 tablets per day (4mg/day), with 2 tablets in the morning and 2 before bed.
Nabilone
Nabilone is a synthetic cannabinoid that has shown benefit for agitation in Alzheimer's disease. Nabilone further has potentially beneficial properties on oxidative stress and inflammation in neurodegenerative diseases, mechanisms that have been linked to the pathophysiology of frontotemporal dementia.
Placebo
Weeks 1 and 2 Participants will receive one capsule per day to be taken orally before bedtime.
Weeks 3-4 Participants will receive 2 capsules per day, one in the morning and one before bedtime.
Weeks 5-6 Participants will receive 2 capsules per day, one in the morning and one before bedtime.
The placebo dosing regimen is designed to be as similar as possible to the nabilone dosing regime, including using identical capsules.
Placebo
The placebo is a capsule identical to the nabilone capsules that will be used in this clinical trial.
Interventions
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Nabilone
Nabilone is a synthetic cannabinoid that has shown benefit for agitation in Alzheimer's disease. Nabilone further has potentially beneficial properties on oxidative stress and inflammation in neurodegenerative diseases, mechanisms that have been linked to the pathophysiology of frontotemporal dementia.
Placebo
The placebo is a capsule identical to the nabilone capsules that will be used in this clinical trial.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Major neurocognitive disorder due to probable behavioural variant FTD (Rascovsky criteria)17 or primary progressive aphasia (Gorno-Tempini criteria)18. All ages and severity levels will be included.
* Meets International Psychogeriatric Association criteria for agitation in cognitive disorders19
* CMAI score of 39 or above
* Stable psychoactive medication for 2 weeks prior to screening (all medications allowed) with no intention to change dose during treatment period
* Available study partner with ≥10 hours per week in-person contact with the patient. This can either be a friend/family member or a staff member at an assisted living facility.
* Capacity to provide written consent in English or French, or consent from official surrogate decision maker in case of incapacity
Exclusion Criteria
* Clinically significant orthostatic hypotension (a decrease in systolic blood pressure of 20 mm Hg or in diastolic blood pressure of 10 mm Hg within three minutes of standing compared to blood pressure in a seated position)
* Symptomatic orthostatic tachycardia (heart rate increase from of at least 30 beats per minute within the first 5 minutes of standing compared to a seated position IF orthostatic hypotension is not a problem)
* Unstable cardiovascular condition in the opinion of the investigator
* Known or suspected history of drug or alcohol dependence or abuse in the past 12 months, including use of any psychomimetic drugs (e.g. ketamine, lysergic acid diethylamide, psilocybin).
* Allergy, or significant adverse reaction to cannabinoids. If the adverse reaction involved psychological symptoms that are indicative of psychosis or severe anxiety the patient will be excluded. Their treating clinician may be consulted for a clinical opinion on the severity of the response to cannabis and whether this justifies exclusion from the trial.
* Major depressive episode within 6 months of screening
* Women who are breast feeding or pregnant
* Severe liver dysfunction, as determined by their treating clinician
* Other psychiatric or neurological condition that could cause significant agitation
* Ongoing use of any cannabinoid-related products. This includes any THC or CBD based products, regardless of administration method (oral, inhalation, topical, etc…)
18 Years
ALL
No
Sponsors
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Alzheimer's Drug Discovery Foundation
OTHER
Simon Ducharme, MD
OTHER
Responsible Party
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Simon Ducharme, MD
Associate Professor, McGill University
Locations
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University of British Columbia, St Paul's Hospital
Vancouver, British Columbia, Canada
Brain and Mind Institute, University of Western Ontario
London, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Baycrest Hospital, University of Toronto
Toronto, Ontario, Canada
Western Hospital - University of Toronto
Toronto, Ontario, Canada
CHU de Québec, Université Laval
Laval, Quebec, Canada
The Douglas Research Centre
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Nabilone-FTD
Identifier Type: -
Identifier Source: org_study_id
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