Trial | NCT01386333  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    23
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 Started
Jun 30
2011
Primary Completion
Oct 31
2013
Last Update
Nov 03
2013
Estimate

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

Oxytocin 24IU Experimental

Oxytocin 24 IU administered intranasally twice daily for 1 week

Oxytocin 48 IU Experimental

48 IU of intranasal oxytocin administered twice daily for 1 week

72 IU oxytocin Experimental

72 IU of intranasal oxytocin administered twice daily for 1 week

Saline nasal spray Placebo Comparator

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.
No Results Posted