Impact of Emotional Mimicry and Oxytocin on Frontotemporal Dementia

Phase 2

Completed

• Conditions: Frontotemporal Dementia
• Interventions: Drug: Intranasal oxytocin; Drug: Saline Nasal Mist

• Registration Number: NCT01937013
• Lead Sponsor: 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.

Study Timeline

• Study First Submitted: 2013-09-03
• Study First Submitted QC: 2013-09-03
• Study First Posted: 2013-09-09
• Study Start: 2013-09-12
• Primary Completion: 2017-12-21
• Study Completion: 2017-12-21
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-07
• Last Update Posted: 2018-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intranasal Oxytocin	Intranasal oxytocin	Participants will be randomized to receive 72 IU intranasal oxytocin on either study visit 2 or 3
Saline Nasal Mist	Saline Nasal Mist	Participants will be randomized to receive intranasal saline mist (placebo) on opposite visits from the interventional drug visit 2 or 3

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Cognitive and Emotional Task performance	2 weeks	Performance on standardized tasks of emotion processing and cognition

Trial Locations

Locations (1)

Parkwood Hospital; 🇨🇦 London, Ontario, Canada