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Safety Study of Intranasal Oxytocin in Frontotemporal Dementia

NCT ID: NCT01386333

Last Updated: 2013-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Frontotemporal Dementia

Keywords

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Frontotemporal Dementia oxytocin Pick's disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Oxytocin 24IU

Oxytocin 24 IU administered intranasally twice daily for 1 week

Group Type EXPERIMENTAL

oxytocin

Intervention Type 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

Oxytocin 48 IU

48 IU of intranasal oxytocin administered twice daily for 1 week

Group Type EXPERIMENTAL

oxytocin

Intervention Type 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

72 IU oxytocin

72 IU of intranasal oxytocin administered twice daily for 1 week

Group Type EXPERIMENTAL

oxytocin

Intervention Type 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 spray

Group Type PLACEBO_COMPARATOR

oxytocin

Intervention Type 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

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Saline Nasal Mist

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Consortium of Canadian Centres for Clinical Cognitive Research

OTHER

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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Elizabeth Finger

Cognitive Neurologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elizabeth C Finger, MD

Role: PRINCIPAL_INVESTIGATOR

University of Western Ontario, Lawson Health Research Institute

Locations

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Cognitive Neurology and Alzheimer Research Centre

London, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 25503617 (View on PubMed)

Other Identifiers

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17783

Identifier Type: OTHER

Identifier Source: secondary_id

R-11-232

Identifier Type: -

Identifier Source: org_study_id