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RECRUITING
NCT05742698
PHASE2

Nabilone for Agitation in Frontotemporal Dementia

Sponsor: Simon Ducharme, MD

View on ClinicalTrials.gov

Summary

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.

Official title: Double Blind Crossover Clinical Trial of Nabilone for Agitation in Frontotemporal Dementia

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2023-03-07

Completion Date

2026-05

Last Updated

2025-04-15

Healthy Volunteers

No

Interventions

DRUG

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.

DRUG

Placebo

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

Locations (7)

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