Safety Study of Intranasal Oxytocin in Frontotemporal Dementia (FTDOXY10EF)
This study is currently recruiting participants.
Verified June 2011 by Lawson Health Research Institute
Sponsor:
Lawson Health Research Institute
Collaborator:
The Consortium of Canadian Centres for Clinical Cognitive Research (C5R)
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01386333
First received: June 29, 2011
Last updated: June 30, 2011
Last verified: June 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Frontotemporal Dementia |
Drug: oxytocin Drug: Saline Nasal Mist |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase I Dose Finding Study of Intranasal Oxytocin in Frontotemporal Dementia, Protocol # FTDOXY10EF |
Resource links provided by NLM:
Genetics Home Reference related topics:
CHMP2B-related frontotemporal dementia
frontotemporal dementia with parkinsonism-17
GRN-related frontotemporal dementia
inclusion body myopathy with early-onset Paget disease and frontotemporal dementia
MedlinePlus related topics:
Dementia
Drug Information available for:
Oxytocin
U.S. FDA Resources
Further study details as provided by Lawson Health Research Institute:
Primary Outcome Measures:
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 2 week ] [ Designated as safety issue: Yes ]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 asssessed by a standardized questionaire and serum sodium levels will be monitored.
Secondary Outcome Measures:
- Neuropsychiatric Inventory [ Time Frame: 1 week ] [ Designated as safety issue: No ]Behavioural ratings at baseline and 1 week of oxytocin treatment compared to 1 week of placebo treatment
- Frontal Behavioural Inventory [ Time Frame: 1 week ] [ Designated as safety issue: No ]
- Clinicians Global Impression of Change [ Time Frame: 1 week ] [ Designated as safety issue: No ]
- Clinical Dementia Rating- Frontotemporal Lobar Degeneration [ Time Frame: 1 week ] [ Designated as safety issue: No ]
- Interpersonal Reactivity Index [ Time Frame: 1 week ] [ Designated as safety issue: No ]
- Multi-faceted Empathy Test [ Time Frame: 1 week ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 24 |
| Study Start Date: | June 2011 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 30 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age 30-80 years
- Meets Neary criteria for diagnosis of probably 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01386333
Contacts
| Contact: Sarah Jesso, BA | 519-646-6000 ext 64852 | |
| Contact: Darlyne Morlog, RNA | 519-646-6000 ext 64605 |
Locations
| Canada, Ontario | |
| Cognitive Neurology and Alzheimer Research Centre | Recruiting |
| London, Ontario, Canada, N6A 4V2 | |
| Contact: Sarah Jesso 519-646-6000 ext 64852 | |
| Principal Investigator: Elizabeth Finger, MD | |
| Sub-Investigator: Andrew Kertesz, MD | |
Sponsors and Collaborators
Lawson Health Research Institute
The Consortium of Canadian Centres for Clinical Cognitive Research (C5R)
Investigators
| Principal Investigator: | Elizabeth C Finger, MD | University of Western Ontario, Lawson Health Research Institute |
More Information
No publications provided
| Responsible Party: | PI: Elizabeth Finger, MD, Lawson Health Research Institute |
| ClinicalTrials.gov Identifier: | NCT01386333 History of Changes |
| Other Study ID Numbers: | R-11-232, 17783 |
| Study First Received: | June 29, 2011 |
| Last Updated: | June 30, 2011 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Lawson Health Research Institute:
|
Frontotemporal Dementia oxytocin Pick's disease |
Additional relevant MeSH terms:
|
Dementia Frontotemporal Dementia Aphasia, Primary Progressive Pick Disease of the Brain Brain Diseases Central Nervous System Diseases Nervous System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Frontotemporal Lobar Degeneration TDP-43 Proteinopathies Neurodegenerative Diseases Proteostasis Deficiencies Metabolic Diseases |
Aphasia Speech Disorders Language Disorders Communication Disorders Neurobehavioral Manifestations Neurologic Manifestations Signs and Symptoms Oxytocin Oxytocics Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013