Frontotemporal Dementia
Conditions
Keywords
Frontotemporal Dementia, emotion, oxytocin, fMRI
Brief summary
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.
Detailed description
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.
Interventions
DRUGIntranasal oxytocin
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.
Participants will be randomized to receive placebo on either study visit 2 or 3.
Sponsors
Canadian Institutes of Health Research (CIHR)
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
Patients: * Ages 30-85 * meet consensus criteria for probable behavioural variant FTD (bvFTD) Controls: * Age and sex matched with patients * Mini-Mental State Exam (MMSE) scores \>27
Exclusion criteria
Patients: * history of stroke * intracranial haemorrhage or other medical or neurological disorder apart from FTD that could affect cognition * diagnosis of bipolar disorder or schizophrenia not better accounted for by the diagnosis of FTD * cognitive impairment that precludes comprehension of task instructions * contraindication to MRI scanning * severe language or memory deficits that preclude participation in the study visits and measures * females who are pregnant or breastfeeding (a pregnancy test will be done on females who have not completed menopause). * uncontrolled hypertension * bradycardia (rate \<48 bpm) or tachycardia (rate \> 100 bpm) * current use of prostaglandins Controls: * history of stroke * intracranial haemorrhage or other medical or neurological disorder * diagnosis of bipolar disorder or schizophrenia * cognitive impairment that precludes comprehension of task instructions * contraindication to MRI scanning * severe language or memory deficits that preclude participation in the study visits and measures * females who are pregnant or breastfeeding (a pregnancy test will be done on females who have not completed menopause). * uncontrolled hypertension * bradycardia (rate \<48 bpm) or tachycardia (rate \> 100 bpm) * current use of prostaglandins
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional magnetic resonance imaging (fMRI) BOLD signal | 2 weeks | Measures of BOLD (Blood Oxygen-Level Dependent) signal change during oxytocin compared to placebo during functional MRI scans |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive and Emotional Task performance | 2 weeks | Performance on standardized tasks of emotion processing and cognition |
Countries
Canada
Outcome results
None listed