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| ID | Type | Description | Link |
|---|---|---|---|
| 166786 | Other Identifier | Health Canada | |
| 103555 | Other Identifier | Western HSREB | |
| FTDOXY13EF | Other Identifier | Internal |
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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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This study will evaluate the effects on emotions and neural activity of a one time dose of intranasal oxytocin vs. placebo in patients with FTD and healthy controls.
Frontotemporal dementia (FTD) and Pick's disease cause changes in personality, behaviour, and emotional responses. The usual treatments for Frontotemporal dementia focus on reducing agitation and aggressive behaviours. However, these drugs do not help all patients who experience blunting of emotion and loss of empathy. This study will evaluate the effects on emotions and neural activity of a one time dose of intranasal oxytocin vs. placebo in patients with FTD and healthy controls.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intranasal Oxytocin | Experimental | Participants will be randomized to receive 72 IU intranasal oxytocin on either study visit 2 or 3 |
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| Saline Nasal Mist | Placebo Comparator | Participants will be randomized to receive intranasal saline mist (placebo) on opposite visits from the interventional drug visit 2 or 3 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intranasal oxytocin | Drug | Oxytocin can be given intravenously (with a needle) or intranasally (a spray into the nose). The intravenous form of drug is approved by Health Canada for use in pregnancy. The intranasal formulation is not currently approved for use by Health Canada, but is used in Europe to induce labour in pregnant women or aid lactation (breastfeeding). Participants will be randomized to receive 72 IU intranasal oxytocin on either study visit 2 or 3. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional magnetic resonance imaging (fMRI) BOLD signal | Measures of BOLD (Blood Oxygen-Level Dependent) signal change during oxytocin compared to placebo during functional MRI scans | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive and Emotional Task performance | Performance on standardized tasks of emotion processing and cognition | 2 weeks |
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Inclusion Criteria:
Patients:
Controls:
Exclusion Criteria:
Patients:
Controls:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth C Finger, M.D. | LawsonHRI, London Health Sciences Centre, Western University, Schulich School of Medicine | Principal Investigator |
| Derek Mitchell, PhD | Western University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parkwood Hospital | London | Ontario | N6C 5J1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32963103 | Derived | Oliver LD, Stewart C, Coleman K, Kryklywy JH, Bartha R, Mitchell DGV, Finger EC. Neural effects of oxytocin and mimicry in frontotemporal dementia: A randomized crossover study. Neurology. 2020 Nov 10;95(19):e2635-e2647. doi: 10.1212/WNL.0000000000010933. Epub 2020 Sep 22. |
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| ID | Term |
|---|---|
| D057180 | Frontotemporal Dementia |
| ID | Term |
|---|---|
| D057174 | Frontotemporal Lobar Degeneration |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| Saline Nasal Mist | Drug | Participants will be randomized to receive placebo on either study visit 2 or 3. |
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| 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 |