The purpose of this study is to assess the safety, tolerability and effects on behaviour of Syntocinon given intranasally (by a spray into the nostrils) compared to placebo (an inactive saline substance that contains no medication) in participants with frontotemporal dementia/Pick's disease. This study will take place in approximately 15 centres across Canada and the United States. Approximately 112 patients in total will be enrolled in this study. In the first phase we will examine which of three different dosing schedules of oxytocin may be more effective. In the second phase of the study, patients entering the study will be randomized to the oxytocin dosing schedule that appeared most effective in the first phase.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
112
Intranasal Oxytocin
UCLA
Los Angeles, California, United States
University of California, San Francisco
San Francisco, California, United States
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States
Columbia University Medical Center
New York, New York, United States
University of Washington
Seattle, Washington, United States
University of British Columbia
Vancouver, British Columbia, Canada
Parkwood Institute
London, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
Montreal Neurological Institute and Hospital
Montreal, Quebec, Canada
...and 1 more locations
Change in Neuropsychiatric Inventory (NPI) apathy/indifference domain score
Pilot data from our two prior studies of oxytocin in FTD have driven the selection of the NPI as the primary outcome measure.
Time frame: Up to 20 weeks
Change in emotional facial expression recognition performance
Time frame: Up to 20 weeks
Change in the Revised Self-Monitoring Scale score
Time frame: Up to 20 weeks
Change in modified Clinicians Global Impression of Change (apathy) scores
Time frame: Up to 20 weeks
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