Clinical trial NCT01386333: Safety Study of Intranasal Oxytocin in Frontotemporal Dementia
Official title: A Phase I Dose Finding Study of Intranasal Oxytocin in Frontotemporal Dementia, Protocol # FTDOXY10EF
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Frontotemporal Dementia
Keywords: Frontotemporal Dementia
oxytocin
Pick's disease
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Consortium of Canadian Centres for Clinical Cognitive Research
First posted: 2011-07-01
Enrollment: 23
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 2 week
Secondary outcomes:
measure: Neuropsychiatric Inventory
timeFrame: 1 week
measure: Frontal Behavioural Inventory
timeFrame: 1 week
measure: Clinicians Global Impression of Change
timeFrame: 1 week
measure: Clinical Dementia Rating- Frontotemporal Lobar Degeneration
timeFrame: 1 week
measure: Interpersonal Reactivity Index
timeFrame: 1 week
measure: Multi-faceted Empathy Test
timeFrame: 1 week
Other outcomes:
Locations:
city: London
country: Canada
facility: Cognitive Neurology and Alzheimer Research Centre
state: Ontario
Study officials:
affiliation: University of Western Ontario, Lawson Health Research Institute
name: Elizabeth C Finger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Finger EC, MacKinley J, Blair M, Oliver LD, Jesso S, Tartaglia MC, Borrie M, Wells J, Dziobek I, Pasternak S, Mitchell DG, Rankin K, Kertesz A, Boxer A. Oxytocin for frontotemporal dementia: a randomized dose-finding study of safety and tolerability. Neurology. 2015 Jan 13;84(2):174-81. doi: 10.1212/WNL.0000000000001133. Epub 2014 Dec 10.