Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 17783 | Other Identifier | REB |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Consortium of Canadian Centres for Clinical Cognitive Research | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oxytocin | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | 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. | 2 week |
| Measure | Description | Time Frame |
|---|---|---|
| Neuropsychiatric Inventory | Behavioural ratings at baseline and 1 week of oxytocin treatment compared to 1 week of placebo treatment | 1 week |
| Frontal Behavioural Inventory | 1 week |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Elizabeth C Finger, MD | University of Western Ontario, Lawson Health Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cognitive Neurology and Alzheimer Research Centre | London | Ontario | N6A 4V2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25503617 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D057180 | Frontotemporal Dementia |
| D020774 | Pick Disease of the Brain |
| ID | Term |
|---|---|
| D057174 | Frontotemporal Lobar Degeneration |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Saline Nasal Mist | Drug | Placebo arm wil receive saline nasal mist sprays matched in number to oxytocin dose cohorts |
|
| Clinicians Global Impression of Change | 1 week |
| Clinical Dementia Rating- Frontotemporal Lobar Degeneration | 1 week |
| Interpersonal Reactivity Index | 1 week |
| Multi-faceted Empathy Test | 1 week |
| D009422 | Nervous System Diseases |
| D057177 | TDP-43 Proteinopathies |
| D019636 | Neurodegenerative Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |