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Oxytocin and Social Cognition in Frontotemporal Dementia

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01002300
Enrollment
24
Registered
2009-10-27
Start date
2009-09-30
Completion date
2010-11-30
Last updated
2014-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frontotemporal Dementia, Pick's Disease

Keywords

Social Cognition, Oxytocin

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.

Interventions

DRUGintranasal 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.

Sponsors

The Alzheimer Society London and Middlesex
CollaboratorOTHER
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Performance on Emotion Recognition TasksDay of treatment

Secondary

MeasureTime frame
Behavioural Ratings of Emotional Sensitivity and Repetitive BehavioursOne week following treatment
Side effects1 week after treatment

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026