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Safety Study of Intranasal Oxytocin in Frontotemporal Dementia (FTDOXY10EF)

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ClinicalTrials.gov Identifier: NCT01386333
Recruitment Status : Completed
First Posted : July 1, 2011
Last Update Posted : November 3, 2013
Sponsor:
Collaborator:
Consortium of Canadian Centres for Clinical Cognitive Research
Information provided by (Responsible Party):
Elizabeth Finger, Lawson Health Research Institute

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Frontotemporal Dementia Drug: oxytocin Drug: Saline Nasal Mist Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase I Dose Finding Study of Intranasal Oxytocin in Frontotemporal Dementia, Protocol # FTDOXY10EF
Study Start Date : June 2011
Actual Primary Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia
Drug Information available for: Oxytocin

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 2 week ]
    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 :
  1. Neuropsychiatric Inventory [ Time Frame: 1 week ]
    Behavioural ratings at baseline and 1 week of oxytocin treatment compared to 1 week of placebo treatment

  2. Frontal Behavioural Inventory [ Time Frame: 1 week ]
  3. Clinicians Global Impression of Change [ Time Frame: 1 week ]
  4. Clinical Dementia Rating- Frontotemporal Lobar Degeneration [ Time Frame: 1 week ]
  5. Interpersonal Reactivity Index [ Time Frame: 1 week ]
  6. Multi-faceted Empathy Test [ Time Frame: 1 week ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01386333


Locations
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Canada, Ontario
Cognitive Neurology and Alzheimer Research Centre
London, Ontario, Canada, N6A 4V2
Sponsors and Collaborators
Lawson Health Research Institute
Consortium of Canadian Centres for Clinical Cognitive Research
Investigators
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Principal Investigator: Elizabeth C Finger, MD University of Western Ontario, Lawson Health Research Institute
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Elizabeth Finger, Cognitive Neurologist, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01386333    
Other Study ID Numbers: R-11-232
17783 ( Other Identifier: REB )
First Posted: July 1, 2011    Key Record Dates
Last Update Posted: November 3, 2013
Last Verified: November 2013
Keywords provided by Elizabeth Finger, Lawson Health Research Institute:
Frontotemporal Dementia
oxytocin
Pick's disease
Additional relevant MeSH terms:
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Dementia
Frontotemporal Dementia
Aphasia, Primary Progressive
Pick Disease of the Brain
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Neurodegenerative Diseases
Frontotemporal Lobar Degeneration
TDP-43 Proteinopathies
 Proteostasis Deficiencies
Metabolic Diseases
Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs