Oxytocin and Social Cognition in Frontotemporal Dementia

NCT ID: NCT01002300

Last Updated: 2014-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2010-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Syntocinon

Eligibility 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Alzheimer Society London and Middlesex

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth Finger

Cognitive Neurologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elizabeth C Finger, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

London, Ontario, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 17888410 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 18988842 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16904652 (View on PubMed)

Other Identifiers

15398

Identifier Type: -

Identifier Source: secondary_id

R-08-395

Identifier Type: -

Identifier Source: org_study_id