Safety Study of Intranasal Oxytocin in Frontotemporal Dementia

Phase 1

Completed

• Conditions: Frontotemporal Dementia
• Interventions: Drug: oxytocin; Drug: Saline Nasal Mist

• Registration Number: NCT01386333
• Lead Sponsor: Lawson Health Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-29
• Study First Submitted QC: 2011-06-30
• Study First Posted: 2011-07-01
• Primary Completion: 2013-10
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-01
• Last Update Posted: 2013-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxytocin 24IU	oxytocin	Oxytocin 24 IU administered intranasally twice daily for 1 week
Saline nasal spray	Saline Nasal Mist	-
Oxytocin 48 IU	oxytocin	48 IU of intranasal oxytocin administered twice daily for 1 week
72 IU oxytocin	oxytocin	72 IU of intranasal oxytocin administered twice daily for 1 week
Saline nasal spray	oxytocin	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Neuropsychiatric Inventory	1 week	Behavioural ratings at baseline and 1 week of oxytocin treatment compared to 1 week of placebo treatment
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

Trial Locations

Locations (1)

Cognitive Neurology and Alzheimer Research Centre; 🇨🇦 London, Ontario, Canada