Safety Study of Intranasal Oxytocin in Frontotemporal Dementia (FTDOXY10EF)
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ClinicalTrials.gov Identifier: NCT01386333 |
Recruitment Status :
Completed
First Posted : July 1, 2011
Last Update Posted : November 3, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Frontotemporal Dementia | Drug: oxytocin Drug: Saline Nasal Mist | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 23 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase I Dose Finding Study of Intranasal Oxytocin in Frontotemporal Dementia, Protocol # FTDOXY10EF |
Study Start Date : | June 2011 |
Actual Primary Completion Date : | October 2013 |

Arm | Intervention/treatment |
---|---|
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 |
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 2 week ]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.
- Neuropsychiatric Inventory [ Time Frame: 1 week ]Behavioural ratings at baseline and 1 week of oxytocin treatment compared to 1 week of placebo treatment
- Frontal Behavioural Inventory [ Time Frame: 1 week ]
- Clinicians Global Impression of Change [ Time Frame: 1 week ]
- Clinical Dementia Rating- Frontotemporal Lobar Degeneration [ Time Frame: 1 week ]
- Interpersonal Reactivity Index [ Time Frame: 1 week ]
- Multi-faceted Empathy Test [ Time Frame: 1 week ]

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Ages Eligible for Study: | 30 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01386333
Canada, Ontario | |
Cognitive Neurology and Alzheimer Research Centre | |
London, Ontario, Canada, N6A 4V2 |
Principal Investigator: | Elizabeth C Finger, MD | University of Western Ontario, Lawson Health Research Institute |
Responsible Party: | Elizabeth Finger, Cognitive Neurologist, Lawson Health Research Institute |
ClinicalTrials.gov Identifier: | NCT01386333 |
Other Study ID Numbers: |
R-11-232 17783 ( Other Identifier: REB ) |
First Posted: | July 1, 2011 Key Record Dates |
Last Update Posted: | November 3, 2013 |
Last Verified: | November 2013 |
Frontotemporal Dementia oxytocin Pick's disease |
Dementia Frontotemporal Dementia Aphasia, Primary Progressive Pick Disease of the Brain Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurocognitive Disorders Mental Disorders Neurodegenerative Diseases Frontotemporal Lobar Degeneration TDP-43 Proteinopathies |
Proteostasis Deficiencies Metabolic Diseases Aphasia Speech Disorders Language Disorders Communication Disorders Neurobehavioral Manifestations Neurologic Manifestations Oxytocin Oxytocics Reproductive Control Agents Physiological Effects of Drugs |