IEMO: Impact of Emotional Mimicry and Oxytocin on Frontotemporal Dementia

Sponsor

Lawson Health Research Institute (Other)

Overall Status

Completed

CT.gov ID

NCT01937013

Collaborator

Canadian Institutes of Health Research (CIHR) (Other)

Enrollment

Location

Arms

51.3

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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 :

Sep 12, 2013

Actual Primary Completion Date :

Dec 21, 2017

Actual Study Completion Date :

Dec 21, 2017

Arms and Interventions

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 Names: 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 Names: Placebo

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 Names:

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 Names:

Placebo

Outcome Measures

Primary Outcome Measures

Functional magnetic resonance imaging (fMRI) BOLD signal [2 weeks]
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 [2 weeks]
Performance on standardized tasks of emotion processing and cognition

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Parkwood Hospital	London	Ontario	Canada	N6C 5J1

Sponsors and Collaborators

Lawson Health Research Institute
Canadian Institutes of Health Research (CIHR)

Investigators

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