Impact of Emotional Mimicry and Oxytocin on Frontotemporal Dementia

Frontotemporal Dementia Clinical Trial

— IEMO  

Official title:

Impact of Emotional Mimicry and Oxytocin on Frontotemporal Dementia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01937013
• Other study ID #: R-13-270
• Secondary ID: 166786103555FTDO
• Status: Completed
• Phase: Phase 2
• Start date: September 12, 2013
• Est. completion date: December 21, 2017

Study information

• Verified date: August 2018
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 21, 2017
• Est. primary completion date: December 21, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Aphasia, Primary Progressive
• Dementia
• Frontotemporal Dementia
• Pick Disease of the Brain

Intervention

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.
• Saline Nasal Mist
Participants will be randomized to receive placebo on either study visit 2 or 3.

Locations

Country	Name	City	State
Canada	Parkwood Hospital	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional magnetic resonance imaging (fMRI) BOLD signal	Measures of BOLD (Blood Oxygen-Level Dependent) signal change during oxytocin compared to placebo during functional MRI scans	2 weeks
Secondary	Cognitive and Emotional Task performance	Performance on standardized tasks of emotion processing and cognition	2 weeks