Clinical trial NCT01002300: Oxytocin and Social Cognition in Frontotemporal Dementia
Official title: Investigation of the Effects of Intranasal Oxytocin on Cognition and Emotion Processing in Frontotemporal Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frontotemporal Dementia
Pick's Disease
Keywords: Social Cognition
Oxytocin
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: The Alzheimer Society London and Middlesex
First posted: 2009-10-27
Enrollment: 24
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Performance on Emotion Recognition Tasks
timeFrame: Day of treatment
Secondary outcomes:
measure: Behavioural Ratings of Emotional Sensitivity and Repetitive Behaviours
timeFrame: One week following treatment
measure: Side effects
timeFrame: 1 week after treatment
Other outcomes:
Locations:
city: London
country: Canada
facility: Cognitive Neurology and Alzheimer's Research Centre, St. Joseph's Hospital
state: Ontario
Study officials:
affiliation: University of Western Ontario/ St. Joseph's Hospital, Lawson Research Institute
name: Elizabeth C Finger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guastella AJ, Mitchell PB, Dadds MR. Oxytocin increases gaze to the eye region of human faces. Biol Psychiatry. 2008 Jan 1;63(1):3-5. doi: 10.1016/j.biopsych.2007.06.026. Epub 2007 Sep 21.
citation: Donaldson ZR, Young LJ. Oxytocin, vasopressin, and the neurogenetics of sociality. Science. 2008 Nov 7;322(5903):900-4. doi: 10.1126/science.1158668.
citation: Hollander E, Bartz J, Chaplin W, Phillips A, Sumner J, Soorya L, Anagnostou E, Wasserman S. Oxytocin increases retention of social cognition in autism. Biol Psychiatry. 2007 Feb 15;61(4):498-503. doi: 10.1016/j.biopsych.2006.05.030. Epub 2006 Aug 14.