Safety Study of Intranasal Oxytocin in Frontotemporal Dementia (FTDOXY10EF)

Lawson Health Research Institute

Status and phase: Completed; Phase 1

Conditions: Frontotemporal Dementia

Treatments: Drug: oxytocin; Drug: Saline Nasal Mist

Study type: Interventional

Funder types: Other

Identifiers

NCT01386333

17783 (Other Identifier)

R-11-232

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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23 participants in 4 patient groups, including a placebo group

Oxytocin 24IU

Experimental group

Description:

Oxytocin 24 IU administered intranasally twice daily for 1 week

Treatment:

Drug: oxytocin

Oxytocin 48 IU

Experimental group

Description:

48 IU of intranasal oxytocin administered twice daily for 1 week

Treatment:

Drug: oxytocin

72 IU oxytocin

Experimental group

Description:

72 IU of intranasal oxytocin administered twice daily for 1 week

Treatment:

Drug: oxytocin

Saline nasal spray

Placebo Comparator group

Treatment:

Drug: oxytocin

Drug: Saline Nasal Mist