Impact of Emotional Mimicry and Oxytocin on Frontotemporal Dementia

Impact of Emotional Mimicry and Oxytocin on Frontotemporal Dementia

Sponsors

Lead sponsor: Lawson Health Research Institute

Collaborator: Canadian Institutes of Health Research (CIHR)

Source Lawson Health Research Institute
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.

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.

Overall Status Completed
Start Date September 12, 2013
Completion Date December 21, 2017
Primary Completion Date December 21, 2017
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Functional magnetic resonance imaging (fMRI) BOLD signal 2 weeks
Secondary Outcome
Measure Time Frame
Cognitive and Emotional Task performance 2 weeks
Enrollment 52
Condition
Intervention

Intervention type: Drug

Intervention name: Intranasal oxytocin

Description: 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.

Arm group label: Intranasal Oxytocin

Other name: Syntocinon

Intervention type: Drug

Intervention name: Saline Nasal Mist

Description: Participants will be randomized to receive placebo on either study visit 2 or 3.

Arm group label: Saline Nasal Mist

Other name: Placebo

Eligibility

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

Gender: All

Minimum age: 30 Years

Maximum age: 85 Years

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Location
facility Parkwood Hospital
Location Countries

Canada

Verification Date

August 2018

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Lawson Health Research Institute

Investigator full name: Elizabeth Finger

Investigator title: Principle Investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Intranasal Oxytocin

Arm group type: Experimental

Description: Participants will be randomized to receive 72 IU intranasal oxytocin on either study visit 2 or 3

Arm group label: Saline Nasal Mist

Arm group type: Placebo Comparator

Description: Participants will be randomized to receive intranasal saline mist (placebo) on opposite visits from the interventional drug visit 2 or 3

Acronym IEMO
Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention model: Crossover Assignment

Primary purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov