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Oxytocin and Social Cognition in Frontotemporal Dementia

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ClinicalTrials.gov Identifier: NCT01002300
Recruitment Status : Completed
First Posted : October 27, 2009
Last Update Posted : March 18, 2014
Sponsor:
Collaborator:
The Alzheimer Society London and Middlesex
Information provided by (Responsible Party):
Elizabeth Finger, Lawson Health Research Institute

October 23, 2009
October 27, 2009
March 18, 2014
September 2009
November 2010   (Final data collection date for primary outcome measure)
Performance on Emotion Recognition Tasks [ Time Frame: Day of treatment ]
Same as current
Complete list of historical versions of study NCT01002300 on ClinicalTrials.gov Archive Site
  • Behavioural Ratings of Emotional Sensitivity and Repetitive Behaviours [ Time Frame: One week following treatment ]
  • Side effects [ Time Frame: 1 week after treatment ]
Same as current
Not Provided
Not Provided
 
Oxytocin and Social Cognition in Frontotemporal Dementia
Investigation of the Effects of Intranasal Oxytocin on Cognition and Emotion Processing in Frontotemporal Dementia
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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Frontotemporal Dementia
  • Pick's Disease
Drug: intranasal oxytocin
Participants will receive 24 IU of oxytocin or placebo (Salinex saline nasal spray) intranasally 30 minutes prior to completing the experimental tasks. Two weeks later participants will return for a second visit and receive the alternate drug (either intranasal oxytocin or Salinex) prior to completing the experimental tasks.
Other Name: Syntocinon
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
Same as current
November 2010
November 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
30 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01002300
R-08-395
15398
No
Not Provided
Not Provided
Elizabeth Finger, Lawson Health Research Institute
Lawson Health Research Institute
The Alzheimer Society London and Middlesex
Principal Investigator: Elizabeth C Finger, MD University of Western Ontario/ St. Joseph's Hospital, Lawson Research Institute
Lawson Health Research Institute
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP