Clinical trial NCT01937013: Impact of Emotional Mimicry and Oxytocin on Frontotemporal Dementia
Official title: Impact of Emotional Mimicry and Oxytocin on Frontotemporal Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Frontotemporal Dementia
Keywords: Frontotemporal Dementia
emotion
oxytocin
fMRI
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2013-09-09
Enrollment: 52
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Functional magnetic resonance imaging (fMRI) BOLD signal
timeFrame: 2 weeks
Secondary outcomes:
measure: Cognitive and Emotional Task performance
timeFrame: 2 weeks
Other outcomes:
Locations:
city: London
country: Canada
facility: Parkwood Hospital
state: Ontario
Study officials:
affiliation: LawsonHRI, London Health Sciences Centre, Western University, Schulich School of Medicine
name: Elizabeth C Finger, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Western University
name: Derek Mitchell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oliver LD, Stewart C, Coleman K, Kryklywy JH, Bartha R, Mitchell DGV, Finger EC. Neural effects of oxytocin and mimicry in frontotemporal dementia: A randomized crossover study. Neurology. 2020 Nov 10;95(19):e2635-e2647. doi: 10.1212/WNL.0000000000010933. Epub 2020 Sep 22.