Oxytocin and Social Cognition in Frontotemporal Dementia

Study Overview
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Brief Summary
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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.

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

Conditions
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Frontotemporal Dementia, Pick's Disease

Intervention / Treatment
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* Drug: intranasal oxytocin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance on Emotion Recognition Tasks |  | Day of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavioural Ratings of Emotional Sensitivity and Repetitive Behaviours |  | One week following treatment | 
| Side effects |  | 1 week after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Social Cognition, Oxytocin