Safety Study of Intranasal Oxytocin in Frontotemporal Dementia

Frontotemporal Dementia Clinical Trial

— FTDOXY10EF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01386333
• Other study ID #: R-11-232
• Secondary ID: 17783
• Status: Completed
• Phase: Phase 1
• First received: June 29, 2011
• Last updated: November 1, 2013
• Start date: June 2011

Study information

• Verified date: November 2013
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aphasia, Primary Progressive
• Dementia
• Frontotemporal Dementia
• Pick Disease of the Brain

Intervention

Drug:
• oxytocin
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
• Saline Nasal Mist
Placebo arm wil receive saline nasal mist sprays matched in number to oxytocin dose cohorts

Locations

Country	Name	City	State
Canada	Cognitive Neurology and Alzheimer Research Centre	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Consortium of Canadian Centres for Clinical Cognitive Research

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Neuropsychiatric Inventory	Behavioural ratings at baseline and 1 week of oxytocin treatment compared to 1 week of placebo treatment	1 week	No
Secondary	Frontal Behavioural Inventory		1 week	No
Secondary	Clinicians Global Impression of Change		1 week	No
Secondary	Clinical Dementia Rating- Frontotemporal Lobar Degeneration		1 week	No
Secondary	Interpersonal Reactivity Index		1 week	No
Secondary	Multi-faceted Empathy Test		1 week	No