Oxytocin and Social Cognition in Frontotemporal Dementia

Frontotemporal Dementia Clinical Trial

Official title:

Investigation of the Effects of Intranasal Oxytocin on Cognition and Emotion Processing in Frontotemporal Dementia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01002300
• Other study ID #: R-08-395
• Secondary ID: 15398
• Status: Completed
• Phase: N/A
• First received: October 23, 2009
• Last updated: March 17, 2014
• Start date: September 2009
• Est. completion date: November 2010

Study information

• Verified date: March 2014
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aphasia, Primary Progressive
• Dementia
• Frontotemporal Dementia
• Pick Disease of the Brain
• Pick's Disease

Intervention

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.

Locations

Country	Name	City	State
Canada	Cognitive Neurology and Alzheimer's Research Centre, St. Joseph's Hospital	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Lawson Health Research Institute	The Alzheimer Society London and Middlesex

Country where clinical trial is conducted

Canada, 

References & Publications (3)

Donaldson ZR, Young LJ. Oxytocin, vasopressin, and the neurogenetics of sociality. Science. 2008 Nov 7;322(5903):900-4. doi: 10.1126/science.1158668. Review. — View 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. Epub 2007 Sep 21. — View 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. Epub 2006 Aug 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance on Emotion Recognition Tasks		Day of treatment	No
Secondary	Behavioural Ratings of Emotional Sensitivity and Repetitive Behaviours		One week following treatment	No
Secondary	Side effects		1 week after treatment	Yes