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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Frontotemporal Dementia Pick's Disease Drug: intranasal oxytocin Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Investigation of the Effects of Intranasal Oxytocin on Cognition and Emotion Processing in Frontotemporal Dementia
Study Start Date : September 2009
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia
Drug Information available for: Oxytocin

Arms and Interventions
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Intervention Details:
  • 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

Outcome Measures
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Primary Outcome Measures :
  1. Performance on Emotion Recognition Tasks [ Time Frame: Day of treatment ]

Secondary Outcome Measures :
  1. Behavioural Ratings of Emotional Sensitivity and Repetitive Behaviours [ Time Frame: One week following treatment ]
  2. Side effects [ Time Frame: 1 week after treatment ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01002300


Locations
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Canada, Ontario
Cognitive Neurology and Alzheimer's Research Centre, St. Joseph's Hospital
London, Ontario, Canada, N6A 3T8
Sponsors and Collaborators
Lawson Health Research Institute
The Alzheimer Society London and Middlesex
Investigators
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Principal Investigator: Elizabeth C Finger, MD University of Western Ontario/ St. Joseph's Hospital, Lawson Research Institute
More Information
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Publications:

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Responsible Party: Elizabeth Finger, Cognitive Neurologist, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01002300    
Other Study ID Numbers: R-08-395
15398
First Posted: October 27, 2009    Key Record Dates
Last Update Posted: March 18, 2014
Last Verified: March 2014
Keywords provided by Elizabeth Finger, Lawson Health Research Institute:
Social Cognition
Oxytocin
Additional relevant MeSH terms:
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Dementia
Frontotemporal Dementia
Aphasia, Primary Progressive
Pick Disease of the Brain
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Neurodegenerative Diseases
Frontotemporal Lobar Degeneration
TDP-43 Proteinopathies
 Proteostasis Deficiencies
Metabolic Diseases
Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs