Safety Study of Intranasal Oxytocin in Frontotemporal Dementia (FTDOXY10EF)

This study has been completed.
Sponsor:
Collaborator:
The Consortium of Canadian Centres for Clinical Cognitive Research (C5R)
Information provided by (Responsible Party):
Elizabeth Finger, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01386333
First received: June 29, 2011
Last updated: November 1, 2013
Last verified: November 2013
  Purpose

Oxytocin is a hormone produced by the brain that appears to have important roles in social cognition and emotion in humans. In a pilot study, the effects of a single dose of oxytocin on measures of emotion recognition and behaviour in patients with Frontotemporal Dementia were investigated. The results from the pilot study suggested that oxytocin may be associated with a modest improvement in neuropsychiatric behaviours seen in patients with Frontotemporal Dementia. To further examine the safety and tolerability of oxytocin in this disorder, the present study will examine the safety and tolerability of three different doses of intranasal oxytocin administered to patients with Frontotemporal Dementia twice daily for 1 week.


Condition Intervention Phase
Frontotemporal Dementia
Drug: oxytocin
Drug: Saline Nasal Mist
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase I Dose Finding Study of Intranasal Oxytocin in Frontotemporal Dementia, Protocol # FTDOXY10EF

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 2 week ] [ Designated as safety issue: Yes ]
    Safety and Tolerability of 24 international units (IU), 48 IU and 72 IU of intranasal oxytocin administered twice daily for 1 week to patients with Frontotemporal Dementia as assessed by the number of participants with adverse events. Adverse events will be assessed by a standardized questionnaire and serum sodium levels will be monitored.


Secondary Outcome Measures:
  • Neuropsychiatric Inventory [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Behavioural ratings at baseline and 1 week of oxytocin treatment compared to 1 week of placebo treatment

  • Frontal Behavioural Inventory [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Clinicians Global Impression of Change [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Clinical Dementia Rating- Frontotemporal Lobar Degeneration [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Interpersonal Reactivity Index [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Multi-faceted Empathy Test [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: June 2011
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oxytocin 24IU
Oxytocin 24 IU administered intranasally twice daily for 1 week
Drug: oxytocin
Patients will be randomized to receive intranasal oxytocin or placebo in a dose escalation paradigm with three dose cohorts: 24IU, 48IU and 72IU of intranasal oxytocin twice daily for 1 week
Experimental: Oxytocin 48 IU
48 IU of intranasal oxytocin administered twice daily for 1 week
Drug: oxytocin
Patients will be randomized to receive intranasal oxytocin or placebo in a dose escalation paradigm with three dose cohorts: 24IU, 48IU and 72IU of intranasal oxytocin twice daily for 1 week
Experimental: 72 IU oxytocin
72 IU of intranasal oxytocin administered twice daily for 1 week
Drug: oxytocin
Patients will be randomized to receive intranasal oxytocin or placebo in a dose escalation paradigm with three dose cohorts: 24IU, 48IU and 72IU of intranasal oxytocin twice daily for 1 week
Placebo Comparator: Saline nasal spray Drug: oxytocin
Patients will be randomized to receive intranasal oxytocin or placebo in a dose escalation paradigm with three dose cohorts: 24IU, 48IU and 72IU of intranasal oxytocin twice daily for 1 week
Drug: Saline Nasal Mist
Placebo arm wil receive saline nasal mist sprays matched in number to oxytocin dose cohorts

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 30-80 years
  • Meets "Neary criteria" for diagnosis of probable frontotemporal dementia
  • Neuroimaging (CT, MRI or SPECT scan) supports diagnosis of frontotemporal dementia
  • Provides written informed consent and has a caregiver or legally acceptable representative who provides written informed consent.

Exclusion Criteria:

  • Has a history of a myocardial infarction within the last two years or congestive heart failure.
  • Current uncontrolled hypertension
  • Current bradycardia (rate < 50 beats per minute/bpm) or tachycardia (rate > 100 bpm)
  • Current hyponatremia
  • Current use of prostaglandin medications
  • Females who are pregnant or breastfeeding
  • Use of any investigational or experimental drug or device within the last 60 days prior to screening or within 5 half-lives of the experimental drug , whichever is longer.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01386333

Locations
Canada, Ontario
Cognitive Neurology and Alzheimer Research Centre
London, Ontario, Canada, N6A 4V2
Sponsors and Collaborators
Lawson Health Research Institute
The Consortium of Canadian Centres for Clinical Cognitive Research (C5R)
Investigators
Principal Investigator: Elizabeth C Finger, MD University of Western Ontario, Lawson Health Research Institute
  More Information

No publications provided

Responsible Party: Elizabeth Finger, Cognitive Neurologist, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01386333     History of Changes
Other Study ID Numbers: R-11-232, 17783
Study First Received: June 29, 2011
Last Updated: November 1, 2013
Health Authority: Canada: Health Canada

Keywords provided by Lawson Health Research Institute:
Frontotemporal Dementia
oxytocin
Pick's disease

Additional relevant MeSH terms:
Dementia
Frontotemporal Dementia
Aphasia, Primary Progressive
Pick Disease of the Brain
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Frontotemporal Lobar Degeneration
TDP-43 Proteinopathies
Neurodegenerative Diseases
Proteostasis Deficiencies
Metabolic Diseases
Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on April 20, 2014