Safety Study of Intranasal Oxytocin in Frontotemporal Dementia (FTDOXY10EF)

November 1, 2013 updated by: Elizabeth Finger, Lawson Health Research Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 4V2
        • Cognitive Neurology and Alzheimer Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuropsychiatric Inventory
Time Frame: 1 week
Behavioural ratings at baseline and 1 week of oxytocin treatment compared to 1 week of placebo treatment
1 week
Frontal Behavioural Inventory
Time Frame: 1 week
1 week
Clinicians Global Impression of Change
Time Frame: 1 week
1 week
Clinical Dementia Rating- Frontotemporal Lobar Degeneration
Time Frame: 1 week
1 week
Interpersonal Reactivity Index
Time Frame: 1 week
1 week
Multi-faceted Empathy Test
Time Frame: 1 week
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Collaborators

Consortium of Canadian Centres for Clinical Cognitive Research

Investigators

  • Principal Investigator: Elizabeth C Finger, MD, University of Western Ontario, Lawson Health Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

June 29, 2011

First Submitted That Met QC Criteria

June 30, 2011

First Posted (Estimate)

July 1, 2011

Study Record Updates

Last Update Posted (Estimate)

November 3, 2013

Last Update Submitted That Met QC Criteria

November 1, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-11-232
  • 17783 (REB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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