Investigation of the Effects of Intranasal Oxytocin on Cognition and Emotion Processing in Frontotemporal Dementia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Performance on Emotion Recognition Tasks
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Performance on Emotion Recognition Tasks
Time Frame: Day of treatment
Secondary Outcomes
- Behavioural Ratings of Emotional Sensitivity and Repetitive Behaviours(One week following treatment)
- Side effects(1 week after treatment)
Investigators
Elizabeth Finger
Cognitive Neurologist
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's