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Completed

NCT Number: NCT01002300

Oxytocin and Social Cognition 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.

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Key information

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cognitive Neurology and Alzheimer's Research Centre, St. Joseph's Hospital

London, Ontario, N6A 3T8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intranasal oxytocin

Drug

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 names: Syntocinon

Primary outcomes

  1. Performance on Emotion Recognition Tasks

    Time frame: Day of treatment

Secondary outcomes

  1. Behavioural Ratings of Emotional Sensitivity and Repetitive Behaviours

    Time frame: One week following treatment

  2. Side effects

    Time frame: 1 week after treatment

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Collaborators

  • The Alzheimer Society London and Middlesex

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 27, 2009
Registry last updated
Mar 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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