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Oxytocin and Social Cognition in Frontotemporal Dementia

This study has been completed.
Sponsor:
Collaborator:
The Alzheimer Society London and Middlesex
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01002300
First received: October 23, 2009
Last updated: June 29, 2011
Last verified: June 2011
History of Changes
  Purpose

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 Intervention
Frontotemporal Dementia
Pick's Disease
 Drug: intranasal oxytocin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Investigation of the Effects of Intranasal Oxytocin on Cognition and Emotion Processing in Frontotemporal Dementia

Resource links provided by NLM:

MedlinePlus related topics: Dementia
Drug Information available for: Oxytocin
U.S. FDA Resources

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Performance on Emotion Recognition Tasks [ Time Frame: Day of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Behavioural Ratings of Emotional Sensitivity and Repetitive Behaviours [ Time Frame: One week following treatment ] [ Designated as safety issue: No ]
  • Side effects [ Time Frame: 1 week after treatment ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: September 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01002300

Locations
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
Principal Investigator: Elizabeth C Finger, MD University of Western Ontario/ St. Joseph's Hospital, Lawson Research Institute
  More Information

Publications:

Responsible Party: Elizabeth Finger, MD Assistant Professor, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01002300     History of Changes
Other Study ID Numbers: R-08-395, 15398
Study First Received: October 23, 2009
Last Updated: June 29, 2011
Health Authority: Canada: Health Canada

Keywords provided by Lawson Health Research Institute:
Social Cognition
Oxytocin

Additional relevant MeSH terms:
Dementia
Aphasia, Primary Progressive
Pick Disease of the Brain
Frontotemporal Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
 Neurologic Manifestations
Signs and Symptoms
Frontotemporal Lobar Degeneration
TDP-43 Proteinopathies
Neurodegenerative Diseases
Proteostasis Deficiencies
Metabolic Diseases
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013