Nabilone for Agitation in Frontotemporal Dementia

ConditionsFrontotemporal Dementia Frontotemporal Dementia, Behavioral Variant Primary Progressive Aphasia bvFTD PPA FTD

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorSimon Ducharme, MD

About this trial

The primary goal of this study is to test the hypothesis that oral nabilone treatment will reduce agitation compared with placebo in patients with Frontotemporal Dementia (both behavioural variant frontotemporal dementia and primary progressive aphasia). The study population is defined as patients with probable Frontotemporal Dementia that meet the International Psychogeriatric Association criteria for agitation in cognitive disorders.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Men and women over 18 years

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

Disqualifiers

Clinically significant psychotic symptoms (Neuropsychiatric Inventory domain score (severity x frequency) ≥4 on the delusions or hallucinations subscale)

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

Trial design

Design model

Crossover

Treatments tested in this trial

Nabilone
Drug
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
Drug
The placebo is a capsule identical to the nabilone capsules that will be used in this clinical trial.

Treatment groups

45 Participants

are divided into 2 treatment groups

Group A: NabiloneActive comparator 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Cohen Mansfield Agitation Inventory (CMAI)

A scale that is completed by a caregiver with at lest 10 hours of weekly contact with the patient. This scale evaluates a range of symptoms that fall into the category of agitation.

Time frame

The patients CMAI score will be compared between their Baseline Assessment (prior to starting treatment) and the outcome Assessment (after 6 weeks of treatment) to determine whether agitation has changed across the treatment period.

Secondary outcomes

Tumor necrosis factor alpha (TNFα)

Examine the relationship between TNFα and CMAI scores at baseline and following nabilone treatment.

Time frame

Is TNFα associated with CMAI scores at baseline or with change in CMAI scores after 6-weeks of nabilone treatment (i.e. between Baseline and Outcome Assessments)?

4-hydroxynonenal (4-HNE)

Examine the relationship between 4-HNE and CMAI scores at baseline and following nabilone treatment.

Time frame

Is 4-HNE associated with CMAI scores at baseline or with change in CMAI scores after 6-weeks of nabilone treatment (i.e. between Baseline and Outcome Assessments)?

Other outcomes

Adverse drug reaction (ADR) to varying doses of nabilone

Quantify the prevalence of ADR that occur in response to varying doses of nabilone treatment in patients diagnosed with Frontotemporal Dementia.

Time frame

Count the number of adverse drug reactions that occur accross the 6 week nabiolne treatment period to determine how well this medication is tolerated in this patient population.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Simon Ducharme, MD

Lead sponsor

Douglas Mental Health University Institute

Sponsor institution

Alzheimer's Drug Discovery Foundation

Collaborator

Source ClinicalTrials.gov

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