Oxytocin and Social Cognition in Frontotemporal Dementia

NCT01002300 | Completed

• 2 other identifiers: R-08-39515398
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Frontotemporal Dementia; Pick's Disease

Keywords

Social Cognition; Oxytocin

Outcome Measures

Primary Outcomes (1)

• Performance on Emotion Recognition Tasks

  Day of treatment

Secondary Outcomes (2)

• Behavioural Ratings of Emotional Sensitivity and Repetitive Behaviours

  One week following treatment

• Side effects

  1 week after treatment

Interventions

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.

Also known as: Syntocinon

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of probable Frontotemporal Dementia or Pick's disease
• Caregiver available to participate in all study visits

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• The Alzheimer Society London and Middlesex: collaborator

Study Sites (1)

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

London, Ontario, N6A 3T8, Canada

Location

Related Publications (3)

• 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. doi: 10.1016/j.biopsych.2007.06.026. Epub 2007 Sep 21.

  PMID: 17888410 BACKGROUND

• Donaldson ZR, Young LJ. Oxytocin, vasopressin, and the neurogenetics of sociality. Science. 2008 Nov 7;322(5903):900-4. doi: 10.1126/science.1158668.

  PMID: 18988842 BACKGROUND

• 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. doi: 10.1016/j.biopsych.2006.05.030. Epub 2006 Aug 14.

  PMID: 16904652 BACKGROUND

MeSH Terms

Conditions

Frontotemporal Dementia; Pick Disease of the Brain

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Frontotemporal Lobar Degeneration; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; TDP-43 Proteinopathies; Neurodegenerative Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Elizabeth C Finger, MD

  University of Western Ontario/ St. Joseph's Hospital, Lawson Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cognitive Neurologist

Study Record Dates

• First Submitted: October 23, 2009
• First Posted: October 27, 2009
• Study Start: September 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: March 18, 2014

Record last verified: 2014-03

Locations

CA (1)