Safety Study of Intranasal Oxytocin in Frontotemporal Dementia
A Phase I Dose Finding Study of Intranasal Oxytocin in Frontotemporal Dementia, Protocol # FTDOXY10EF
Lead SponsorUniversity of Western Ontario
StatusCompleted No Results Posted
Intervention/Treatmentoxytocin sodium chloride ...
Oxytocin is a hormone produced by the brain that appears to have important roles in social cognition and emotion in humans. In a pilot study, the effects of a single dose of oxytocin on measures of emotion recognition and behaviour in patients with Frontotemporal Dementia were investigated. The results from the pilot study suggested that oxytocin may be associated with a modest improvement in neuropsychiatric behaviours seen in patients with Frontotemporal Dementia. To further examine the safety and tolerability of oxytocin in this disorder, the present study will examine the safety and tolerability of three different doses of intranasal oxytocin administered to patients with Frontotemporal Dementia twice daily for 1 week.
Patients will be randomized to receive intranasal oxytocin or placebo in a dose escalation paradigm with three dose cohorts: 24IU, 48IU and 72IU of intranasal oxytocin twice daily for 1 week
Placebo arm wil receive saline nasal mist sprays matched in number to oxytocin dose cohorts
Oxytocin 24 IU administered intranasally twice daily for 1 week
48 IU of intranasal oxytocin administered twice daily for 1 week
72 IU of intranasal oxytocin administered twice daily for 1 week
Inclusion Criteria: Age 30-80 years Meets "Neary criteria" for diagnosis of probable frontotemporal dementia Neuroimaging (CT, MRI or SPECT scan) supports diagnosis of frontotemporal dementia Provides written informed consent and has a caregiver or legally acceptable representative who provides written informed consent. Exclusion Criteria: Has a history of a myocardial infarction within the last two years or congestive heart failure. Current uncontrolled hypertension Current bradycardia (rate < 50 beats per minute/bpm) or tachycardia (rate > 100 bpm) Current hyponatremia Current use of prostaglandin medications Females who are pregnant or breastfeeding Use of any investigational or experimental drug or device within the last 60 days prior to screening or within 5 half-lives of the experimental drug , whichever is longer.