A Phase I Dose Finding Study of Intranasal Oxytocin in Frontotemporal Dementia, Protocol # FTDOXY10EF
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Oxytocin 24IU
Oxytocin 24 IU administered intranasally twice daily for 1 week
Intervention: oxytocin (Drug)
Oxytocin 48 IU
48 IU of intranasal oxytocin administered twice daily for 1 week
Intervention: oxytocin (Drug)
72 IU oxytocin
72 IU of intranasal oxytocin administered twice daily for 1 week
Intervention: oxytocin (Drug)
Saline nasal spray
Intervention: oxytocin (Drug)
Saline nasal spray
Intervention: Saline Nasal Mist (Drug)
Outcomes
Primary Outcomes
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: 2 week
Safety and Tolerability of 24 international units (IU), 48 IU and 72 IU of intranasal oxytocin administered twice daily for 1 week to patients with Frontotemporal Dementia as assessed by the number of participants with adverse events. Adverse events will be assessed by a standardized questionnaire and serum sodium levels will be monitored.
Secondary Outcomes
- Neuropsychiatric Inventory(1 week)
- Frontal Behavioural Inventory(1 week)
- Clinicians Global Impression of Change(1 week)
- Clinical Dementia Rating- Frontotemporal Lobar Degeneration(1 week)
- Interpersonal Reactivity Index(1 week)
- Multi-faceted Empathy Test(1 week)
Investigators
Elizabeth Finger
Cognitive Neurologist
Lawson Health Research Institute