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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01937013 |
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Date of registration:
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03/09/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Impact of Emotional Mimicry and Oxytocin on Frontotemporal Dementia
IEMO |
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Scientific title:
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Impact of Emotional Mimicry and Oxytocin on Frontotemporal Dementia |
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Date of first enrolment:
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September 12, 2013 |
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Target sample size:
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52 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01937013 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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Canada
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Contacts
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Name:
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Elizabeth C Finger, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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LawsonHRI, London Health Sciences Centre, Western University, Schulich School of Medicine |
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Name:
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Derek Mitchell, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Western University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Patients:
- Ages 30-85
- meet consensus criteria for probable behavioural variant FTD (bvFTD)
Controls:
- Age and sex matched with patients
- Mini-Mental State Exam (MMSE) scores >27
Exclusion Criteria:
Patients:
- history of stroke
- intracranial haemorrhage or other medical or neurological disorder apart from FTD that
could affect cognition
- diagnosis of bipolar disorder or schizophrenia not better accounted for by the
diagnosis of FTD
- cognitive impairment that precludes comprehension of task instructions
- contraindication to MRI scanning
- severe language or memory deficits that preclude participation in the study visits and
measures
- females who are pregnant or breastfeeding (a pregnancy test will be done on females
who have not completed menopause).
- uncontrolled hypertension
- bradycardia (rate <48 bpm) or tachycardia (rate > 100 bpm)
- current use of prostaglandins
Controls:
- history of stroke
- intracranial haemorrhage or other medical or neurological disorder
- diagnosis of bipolar disorder or schizophrenia
- cognitive impairment that precludes comprehension of task instructions
- contraindication to MRI scanning
- severe language or memory deficits that preclude participation in the study visits and
measures
- females who are pregnant or breastfeeding (a pregnancy test will be done on females
who have not completed menopause).
- uncontrolled hypertension
- bradycardia (rate <48 bpm) or tachycardia (rate > 100 bpm)
- current use of prostaglandins
Age minimum:
30 Years
Age maximum:
85 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Frontotemporal Dementia
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Intervention(s)
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Drug: Intranasal oxytocin
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Drug: Saline Nasal Mist
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Primary Outcome(s)
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Functional magnetic resonance imaging (fMRI) BOLD signal
[Time Frame: 2 weeks]
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Secondary Outcome(s)
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Cognitive and Emotional Task performance
[Time Frame: 2 weeks]
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Secondary ID(s)
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FTDOXY13EF
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166786
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103555
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R-13-270
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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