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Impact of Emotional Mimicry and Oxytocin on Frontotemporal Dementia (IEMO)

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ClinicalTrials.gov Identifier: NCT01937013
Recruitment Status : Completed
First Posted : September 9, 2013
Last Update Posted : August 8, 2018
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Elizabeth Finger, Lawson Health Research Institute

Study Description
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Brief Summary:
This study will evaluate the effects on emotions and neural activity of a one time dose of intranasal oxytocin vs. placebo in patients with FTD and healthy controls.

Condition or disease Intervention/treatment Phase
Frontotemporal Dementia Drug: Intranasal oxytocin Drug: Saline Nasal Mist Phase 2

Detailed Description:
Frontotemporal dementia (FTD) and Pick's disease cause changes in personality, behaviour, and emotional responses. The usual treatments for Frontotemporal dementia focus on reducing agitation and aggressive behaviours. However, these drugs do not help all patients who experience blunting of emotion and loss of empathy. This study will evaluate the effects on emotions and neural activity of a one time dose of intranasal oxytocin vs. placebo in patients with FTD and healthy controls.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Emotional Mimicry and Oxytocin on Frontotemporal Dementia
Actual Study Start Date : September 12, 2013
Actual Primary Completion Date : December 21, 2017
Actual Study Completion Date : December 21, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia
Drug Information available for: Oxytocin

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intranasal Oxytocin
Participants will be randomized to receive 72 IU intranasal oxytocin on either study visit 2 or 3
 Drug: Intranasal oxytocin
Oxytocin can be given intravenously (with a needle) or intranasally (a spray into the nose). The intravenous form of drug is approved by Health Canada for use in pregnancy. The intranasal formulation is not currently approved for use by Health Canada, but is used in Europe to induce labour in pregnant women or aid lactation (breastfeeding). Participants will be randomized to receive 72 IU intranasal oxytocin on either study visit 2 or 3.
Other Name: Syntocinon
Placebo Comparator: Saline Nasal Mist
Participants will be randomized to receive intranasal saline mist (placebo) on opposite visits from the interventional drug visit 2 or 3
 Drug: Saline Nasal Mist
Participants will be randomized to receive placebo on either study visit 2 or 3.
Other Name: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Functional magnetic resonance imaging (fMRI) BOLD signal [ Time Frame: 2 weeks ]
    Measures of BOLD (Blood Oxygen-Level Dependent) signal change during oxytocin compared to placebo during functional MRI scans


Secondary Outcome Measures :
  1. Cognitive and Emotional Task performance [ Time Frame: 2 weeks ]
    Performance on standardized tasks of emotion processing and cognition


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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): NCT01937013


Locations
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Canada, Ontario
Parkwood Hospital
London, Ontario, Canada, N6C 5J1
Sponsors and Collaborators
Lawson Health Research Institute
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Elizabeth C Finger, M.D. LawsonHRI, London Health Sciences Centre, Western University, Schulich School of Medicine
Principal Investigator: Derek Mitchell, PhD Western University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Elizabeth Finger, Principle Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01937013    
Other Study ID Numbers: R-13-270
166786 ( Other Identifier: Health Canada )
103555 ( Other Identifier: Western HSREB )
FTDOXY13EF ( Other Identifier: Internal )
First Posted: September 9, 2013    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Elizabeth Finger, Lawson Health Research Institute:
Frontotemporal Dementia
emotion
oxytocin
fMRI
Additional relevant MeSH terms:
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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