Impact of Emotional Mimicry and Oxytocin on Frontotemporal Dementia

Study Overview
=================
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.

Official Title
-----------------
Impact of Emotional Mimicry and Oxytocin on Frontotemporal Dementia

Conditions
-----------------
Frontotemporal Dementia

Intervention / Treatment
-----------------
* Drug: Intranasal oxytocin
* Drug: Saline Nasal Mist


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intranasal Oxytocin<br>Participants will be randomized to receive 72 IU intranasal oxytocin on either study visit 2 or 3 | Drug: Intranasal oxytocin<br>* 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.<br>* Other names: Syntocinon;|
| Placebo Comparator: Saline Nasal Mist<br>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<br>* Participants will be randomized to receive placebo on either study visit 2 or 3.<br>* Other names: Placebo;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive and Emotional Task performance | Performance on standardized tasks of emotion processing and cognition | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Frontotemporal Dementia, emotion, oxytocin, fMRI