Oxytocin and Social Cognition in Frontotemporal Dementia
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ClinicalTrials.gov Identifier: NCT01002300 |
Recruitment Status :
Completed
First Posted : October 27, 2009
Last Update Posted : March 18, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Frontotemporal Dementia Pick's Disease | Drug: intranasal oxytocin | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Investigation of the Effects of Intranasal Oxytocin on Cognition and Emotion Processing in Frontotemporal Dementia |
Study Start Date : | September 2009 |
Actual Primary Completion Date : | November 2010 |
Actual Study Completion Date : | November 2010 |

- 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.Other Name: Syntocinon
- Performance on Emotion Recognition Tasks [ Time Frame: Day of treatment ]
- Behavioural Ratings of Emotional Sensitivity and Repetitive Behaviours [ Time Frame: One week following treatment ]
- Side effects [ Time Frame: 1 week after treatment ]

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Ages Eligible for Study: | 30 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01002300
Canada, Ontario | |
Cognitive Neurology and Alzheimer's Research Centre, St. Joseph's Hospital | |
London, Ontario, Canada, N6A 3T8 |
Principal Investigator: | Elizabeth C Finger, MD | University of Western Ontario/ St. Joseph's Hospital, Lawson Research Institute |
Responsible Party: | Elizabeth Finger, Cognitive Neurologist, Lawson Health Research Institute |
ClinicalTrials.gov Identifier: | NCT01002300 |
Other Study ID Numbers: |
R-08-395 15398 |
First Posted: | October 27, 2009 Key Record Dates |
Last Update Posted: | March 18, 2014 |
Last Verified: | March 2014 |
Social Cognition Oxytocin |
Dementia Frontotemporal Dementia Aphasia, Primary Progressive Pick Disease of the Brain Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurocognitive Disorders Mental Disorders Neurodegenerative Diseases Frontotemporal Lobar Degeneration TDP-43 Proteinopathies |
Proteostasis Deficiencies Metabolic Diseases Aphasia Speech Disorders Language Disorders Communication Disorders Neurobehavioral Manifestations Neurologic Manifestations Oxytocin Oxytocics Reproductive Control Agents Physiological Effects of Drugs |