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

Oxytocin and Social Cognition in Frontotemporal Dementia

Sponsors

Lead sponsor: Lawson Health Research Institute

Collaborator: The Alzheimer Society London and Middlesex

Source Lawson Health Research Institute
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.

Overall Status Completed
Start Date September 2009
Completion Date November 2010
Primary Completion Date November 2010
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Performance on Emotion Recognition Tasks Day of treatment
Secondary Outcome
Measure Time Frame
Behavioural Ratings of Emotional Sensitivity and Repetitive Behaviours One week following treatment
Side effects 1 week after treatment
Enrollment 24
Condition
Intervention

Intervention type: Drug

Intervention name: intranasal oxytocin

Description: 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

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

Gender: All

Minimum age: 30 Years

Maximum age: 80 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Elizabeth C Finger, MD Principal Investigator University of Western Ontario/ St. Joseph's Hospital, Lawson Research Institute
Location
facility Cognitive Neurology and Alzheimer's Research Centre, St. Joseph's Hospital
Location Countries

Canada

Verification Date

March 2014

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Lawson Health Research Institute

Investigator full name: Elizabeth Finger

Investigator title: Cognitive Neurologist

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Allocation: Randomized

Intervention model: Crossover Assignment

Primary purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov