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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Lawson Health Research Institute
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Elizabeth Finger, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01937013
First received: September 3, 2013
Last updated: September 11, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Frontotemporal Dementia
Drug: Intranasal oxytocin
Drug: Saline Nasal Mist
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Emotional Mimicry and Oxytocin on Frontotemporal Dementia

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Functional magnetic resonance imaging (fMRI) BOLD signal [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Measures of BOLD (Blood Oxygen-Level Dependent) signal change during oxytocin compared to placebo during functional MRI scans


Secondary Outcome Measures:
  • Cognitive and Emotional Task performance [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Performance on standardized tasks of emotion processing and cognition


Estimated Enrollment: 72
Study Start Date: September 2013
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   30 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01937013

Contacts
Contact: Kristy KL Coleman, MSc 519-685-4242 ext 42398

Locations
Canada, Ontario
Parkwood Hospital Recruiting
London, Ontario, Canada, N6C 5J1
Contact: Kristy Coleman, BA    519-685-4242 ext 42398      
Sponsors and Collaborators
Lawson Health Research Institute
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Elizabeth A Finger, M.D. LawsonHRI, London Health Sciences Centre, Western University, Schulich School of Medicine
Principal Investigator: Derek Mitchell, PhD Western University
  More Information

No publications provided

Responsible Party: Elizabeth Finger, Principle Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01937013     History of Changes
Other Study ID Numbers: R-13-270, 166786, 103555, FTDOXY13EF
Study First Received: September 3, 2013
Last Updated: September 11, 2014
Health Authority: Canada: Health Canada

Keywords provided by Lawson Health Research Institute:
Frontotemporal Dementia
emotion
oxytocin
fMRI

Additional relevant MeSH terms:
Speech Disorders
Aphasia, Primary Progressive
Dementia
Frontotemporal Dementia
Pick Disease of the Brain
Aphasia
Brain Diseases
Central Nervous System Diseases
Communication Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Frontotemporal Lobar Degeneration
Language Disorders
Mental Disorders
Metabolic Diseases
Nervous System Diseases
Neurobehavioral Manifestations
Neurodegenerative Diseases
Neurologic Manifestations
Proteostasis Deficiencies
Signs and Symptoms
TDP-43 Proteinopathies
Oxytocin
Oxytocics
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014