Frontotemporal Dementia
Conditions
Keywords
Frontotemporal Dementia, oxytocin, Pick's disease
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.
Interventions
DRUGoxytocin
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
Sponsors
Consortium of Canadian Centres for Clinical Cognitive Research
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | 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
| Measure | Time frame | Description |
|---|---|---|
| Frontal Behavioural Inventory | 1 week | — |
| Clinicians Global Impression of Change | 1 week | — |
| Neuropsychiatric Inventory | 1 week | Behavioural ratings at baseline and 1 week of oxytocin treatment compared to 1 week of placebo treatment |
| Interpersonal Reactivity Index | 1 week | — |
| Multi-faceted Empathy Test | 1 week | — |
| Clinical Dementia Rating- Frontotemporal Lobar Degeneration | 1 week | — |
Countries
Canada
Outcome results
None listed