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Safety Study of Intranasal Oxytocin in Frontotemporal Dementia (FTDOXY10EF)

Primary Purpose

Frontotemporal Dementia

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
oxytocin
Saline Nasal Mist
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frontotemporal Dementia focused on measuring Frontotemporal Dementia, oxytocin, Pick's disease

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cognitive Neurology and Alzheimer Research Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Oxytocin 24IU

Oxytocin 48 IU

72 IU oxytocin

Saline nasal spray

Arm Description

Oxytocin 24 IU administered intranasally twice daily for 1 week

48 IU of intranasal oxytocin administered twice daily for 1 week

72 IU of intranasal oxytocin administered twice daily for 1 week

Outcomes

Primary Outcome Measures

Number of Participants with Adverse Events as a Measure of Safety and Tolerability
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
Behavioural ratings at baseline and 1 week of oxytocin treatment compared to 1 week of placebo treatment
Frontal Behavioural Inventory
Clinicians Global Impression of Change
Clinical Dementia Rating- Frontotemporal Lobar Degeneration
Interpersonal Reactivity Index
Multi-faceted Empathy Test

Full Information

First Posted
June 29, 2011
Last Updated
November 1, 2013
Sponsor
Lawson Health Research Institute
Collaborators
Consortium of Canadian Centres for Clinical Cognitive Research
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1. Study Identification

Unique Protocol Identification Number
NCT01386333
Brief Title
Safety Study of Intranasal Oxytocin in Frontotemporal Dementia
Acronym
FTDOXY10EF
Official Title
A Phase I Dose Finding Study of Intranasal Oxytocin in Frontotemporal Dementia, Protocol # FTDOXY10EF
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute
Collaborators
Consortium of Canadian Centres for Clinical Cognitive Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frontotemporal Dementia
Keywords
Frontotemporal Dementia, oxytocin, Pick's disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxytocin 24IU
Arm Type
Experimental
Arm Description
Oxytocin 24 IU administered intranasally twice daily for 1 week
Arm Title
Oxytocin 48 IU
Arm Type
Experimental
Arm Description
48 IU of intranasal oxytocin administered twice daily for 1 week
Arm Title
72 IU oxytocin
Arm Type
Experimental
Arm Description
72 IU of intranasal oxytocin administered twice daily for 1 week
Arm Title
Saline nasal spray
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
oxytocin
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Saline Nasal Mist
Intervention Description
Placebo arm wil receive saline nasal mist sprays matched in number to oxytocin dose cohorts
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Description
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.
Time Frame
2 week
Secondary Outcome Measure Information:
Title
Neuropsychiatric Inventory
Description
Behavioural ratings at baseline and 1 week of oxytocin treatment compared to 1 week of placebo treatment
Time Frame
1 week
Title
Frontal Behavioural Inventory
Time Frame
1 week
Title
Clinicians Global Impression of Change
Time Frame
1 week
Title
Clinical Dementia Rating- Frontotemporal Lobar Degeneration
Time Frame
1 week
Title
Interpersonal Reactivity Index
Time Frame
1 week
Title
Multi-faceted Empathy Test
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth C Finger, MD
Organizational Affiliation
University of Western Ontario, Lawson Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cognitive Neurology and Alzheimer Research Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
25503617
Citation
Finger EC, MacKinley J, Blair M, Oliver LD, Jesso S, Tartaglia MC, Borrie M, Wells J, Dziobek I, Pasternak S, Mitchell DG, Rankin K, Kertesz A, Boxer A. Oxytocin for frontotemporal dementia: a randomized dose-finding study of safety and tolerability. Neurology. 2015 Jan 13;84(2):174-81. doi: 10.1212/WNL.0000000000001133. Epub 2014 Dec 10.
Results Reference
derived

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Safety Study of Intranasal Oxytocin in Frontotemporal Dementia

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