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NCT Number: NCT01386333

Safety Study of Intranasal Oxytocin in Frontotemporal Dementia

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.

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Key information

Conditions

Frontotemporal Dementia Brain Diseases Central Nervous System Diseases Dementia Frontotemporal Lobar Degeneration Mental Disorders Metabolic Diseases Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Nutritional and Metabolic Diseases Pick Disease of the Brain Proteostasis Deficiencies TDP-43 Proteinopathies

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cognitive Neurology and Alzheimer Research Centre

London, Ontario, N6A 4V2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oxytocin

Drug

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

Saline Nasal Mist

Drug

Placebo arm wil receive saline nasal mist sprays matched in number to oxytocin dose cohorts

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Consortium of Canadian Centres for Clinical Cognitive Research

Registry information

Official study title

A Phase I Dose Finding Study of Intranasal Oxytocin in Frontotemporal Dementia, Protocol # FTDOXY10EF

Acronym: FTDOXY10EF

Important dates

Study start
2011
Primary completion
2013
First posted
Jul 1, 2011
Registry last updated
Nov 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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