Safety Study of Intranasal Oxytocin in Frontotemporal Dementia

Study Overview
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Brief Summary
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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.

Official Title
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A Phase I Dose Finding Study of Intranasal Oxytocin in Frontotemporal Dementia, Protocol # FTDOXY10EF

Conditions
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Frontotemporal Dementia

Intervention / Treatment
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* Drug: oxytocin
* Drug: Saline Nasal Mist


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxytocin 24IU<br>Oxytocin 24 IU administered intranasally twice daily for 1 week | Drug: oxytocin<br>* 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<br>|
| Experimental: Oxytocin 48 IU<br>48 IU of intranasal oxytocin administered twice daily for 1 week | Drug: oxytocin<br>* 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<br>|
| Experimental: 72 IU oxytocin<br>72 IU of intranasal oxytocin administered twice daily for 1 week | Drug: oxytocin<br>* 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<br>|
| Placebo Comparator: Saline nasal spray<br> | Drug: oxytocin<br>* 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<br>Drug: Saline Nasal Mist<br>* Placebo arm wil receive saline nasal mist sprays matched in number to oxytocin dose cohorts<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | 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. | 2 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuropsychiatric Inventory | Behavioural ratings at baseline and 1 week of oxytocin treatment compared to 1 week of placebo treatment | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Frontotemporal Dementia, oxytocin, Pick's disease