Impact of Emotional Mimicry and Oxytocin on Frontotemporal Dementia (IEMO)

Lawson Health Research Institute

Status and phase: Completed; Phase 2

Conditions: Frontotemporal Dementia

Treatments: Drug: Saline Nasal Mist; Drug: Intranasal oxytocin

Study type: Interventional

Funder types: Other

Identifiers

NCT01937013

103555 (Other Identifier)

FTDOXY13EF (Other Identifier)

R-13-270

166786 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 30 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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52 participants in 2 patient groups, including a placebo group

Intranasal Oxytocin

Experimental group

Description:

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

Treatment:

Drug: Intranasal oxytocin

Saline Nasal Mist

Placebo Comparator group

Description:

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

Treatment:

Drug: Saline Nasal Mist