Impact of Emotional Mimicry and Oxytocin on Frontotemporal Dementia

NCT ID: NCT01937013

Last Updated: 2018-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-12
• Study Completion Date: 2017-12-21

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.

Conditions

Frontotemporal Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Intranasal Oxytocin

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

Group Type: EXPERIMENTAL

Intranasal oxytocin

Intervention Type: DRUG

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 intranasal saline mist (placebo) on opposite visits from the interventional drug visit 2 or 3

Group Type: PLACEBO_COMPARATOR

Saline Nasal Mist

Intervention Type: DRUG

Participants will be randomized to receive placebo on either study visit 2 or 3.

Interventions

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.

Intervention Type: DRUG

Saline Nasal Mist

Participants will be randomized to receive placebo on either study visit 2 or 3.

Intervention Type: DRUG

Other Intervention Names

Syntocinon; Placebo

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth Finger

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elizabeth C Finger, M.D.

Role: PRINCIPAL_INVESTIGATOR

LawsonHRI, London Health Sciences Centre, Western University, Schulich School of Medicine

Derek Mitchell, PhD

Role: PRINCIPAL_INVESTIGATOR

Western University

Locations

Parkwood Hospital

London, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 32963103 (View on PubMed)

Other Identifiers

166786

Identifier Type: OTHER

Identifier Source: secondary_id

103555

Identifier Type: OTHER

Identifier Source: secondary_id

FTDOXY13EF

Identifier Type: OTHER

Identifier Source: secondary_id

R-13-270

Identifier Type: -

Identifier Source: org_study_id