Oxytocin and Social Cognition in Frontotemporal Dementia
Primary Purpose
Frontotemporal Dementia, Pick's Disease
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
intranasal oxytocin
Sponsored by
About this trial
This is an interventional treatment trial for Frontotemporal Dementia focused on measuring Social Cognition, Oxytocin
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
Sites / Locations
- Cognitive Neurology and Alzheimer's Research Centre, St. Joseph's Hospital
Outcomes
Primary Outcome Measures
Performance on Emotion Recognition Tasks
Secondary Outcome Measures
Behavioural Ratings of Emotional Sensitivity and Repetitive Behaviours
Side effects
Full Information
NCT ID
NCT01002300
First Posted
October 23, 2009
Last Updated
March 17, 2014
Sponsor
Lawson Health Research Institute
Collaborators
The Alzheimer Society London and Middlesex
1. Study Identification
Unique Protocol Identification Number
NCT01002300
Brief Title
Oxytocin and Social Cognition in Frontotemporal Dementia
Official Title
Investigation of the Effects of Intranasal Oxytocin on Cognition and Emotion Processing in Frontotemporal Dementia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute
Collaborators
The Alzheimer Society London and Middlesex
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frontotemporal Dementia, Pick's Disease
Keywords
Social Cognition, Oxytocin
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
intranasal oxytocin
Other Intervention Name(s)
Syntocinon
Intervention 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.
Primary Outcome Measure Information:
Title
Performance on Emotion Recognition Tasks
Time Frame
Day of treatment
Secondary Outcome Measure Information:
Title
Behavioural Ratings of Emotional Sensitivity and Repetitive Behaviours
Time Frame
One week following treatment
Title
Side effects
Time Frame
1 week after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth C Finger, MD
Organizational Affiliation
University of Western Ontario/ St. Joseph's Hospital, Lawson Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cognitive Neurology and Alzheimer's Research Centre, St. Joseph's Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 3T8
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
17888410
Citation
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.
Results Reference
background
PubMed Identifier
18988842
Citation
Donaldson ZR, Young LJ. Oxytocin, vasopressin, and the neurogenetics of sociality. Science. 2008 Nov 7;322(5903):900-4. doi: 10.1126/science.1158668.
Results Reference
background
PubMed Identifier
16904652
Citation
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.
Results Reference
background
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Oxytocin and Social Cognition in Frontotemporal Dementia
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