Oxytocin and Social Cognition in Frontotemporal Dementia

Not Applicable

Completed

• Conditions: Frontotemporal Dementia; Pick's Disease

• Registration Number: NCT01002300
• Lead Sponsor: Lawson Health Research Institute

Brief Summary

Investigations into the components of cognition damaged in frontotemporal dementia (FTD) demonstrate that patients with FTD show deficits in facial and verbal expression recognition, lack insight into what others think or might do (theory of mind skills), and in decision making tasks requiring processing of positive versus negative feedback. These cognitive functions are thought to be critical for appropriate social behavioural regulation (Blair, 2003). Recent studies in animal models and humans suggest that the neuropeptide oxytocin is an important mediator of social behavior and that oxytocin may facilitate emotion recognition, theory of mind processing, and prosocial behaviors (Donaldson and Young, 2008). Together, these findings suggest that upregulation of oxytocin dependent mechanisms of social and emotional cognition may be a valuable treatment approach in patients with FTD. The aim of this study is to determine how administration of intranasal oxytocin to patients with frontotemporal dementia affects behavior and processing of specific types of social and emotional information.The investigators' hypothesis is that oxytocin administration will improve emotional and social cognitive deficits in patients with FTD, resulting in improved decision making and behaviour.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-10-23
• Study First Submitted QC: 2009-10-26
• Study First Posted: 2009-10-27
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-17
• Last Update Posted: 2014-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Clinical diagnosis of probable Frontotemporal Dementia or Pick's disease
• Caregiver available to participate in all study visits

Exclusion Criteria

• Severe language or memory deficits that preclude completion of the cognitive tasks
• Females who are pregnant or breastfeeding (a pregnancy test will be done on females who have not completed menopause)
• Uncontrolled hypertension
• Bradycardia (rate <50 bpm) or tachycardia (rate > 100 bpm)
• Current use of prostaglandins
• 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: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Performance on Emotion Recognition Tasks	Day of treatment

Secondary Outcome Measures

Name	Time	Method
Behavioural Ratings of Emotional Sensitivity and Repetitive Behaviours	One week following treatment
Side effects	1 week after treatment

Trial Locations

Locations (1)

Cognitive Neurology and Alzheimer's Research Centre, St. Joseph's Hospital; 🇨🇦 London, Ontario, Canada