The effects of intranasal oxytocin on emotion processing and carer burden in individuals diagnosed with frontotemporal dementia
Effects of intranasal oxytocin on emotion processing in frontotemporal dementia
The University of Sydney
1 participants
Feb 4, 2020
Interventional
Conditions
Summary
This trial aims to determine the effects of short-term intranasal oxytocin intervention on emotional processing in individuals diagnosed with Frontotemporal Dementia . We further wish to evaluate whether administration of oxytocin has an effect on carer-burden using standardised questionnaires to capture changes in patient-carer relationships. Who is it for? Patients between the ages of 40 to 75 years, who have been diagnosed with behavioural variant frontotemporal dementia, semantic dementia or progressive non-fluent aphasia, and have a carer who will be able to live with them for the duration of the study are eligible to participate. Study details Patients who have previously been recruited by the Frontier Research Clinic for the 'Clinical Assessment for Ageing and Neurodegeneration Research' study will be contacted to participate in this four-week clinical trial using oxytocin nasal spray. Patients will undergo clinical and neuropsychological assessments at their initial visit, followed by assessments of emotion, cognition, carer-burden and blood sampling at further visits. Patients will be randomised to receive either placebo or oxytocin for one-week, then be off any intervention for one week followed by the counter-intervention for a one-week period. Experimental tasks and clinical assessments will be performed at the Brain and Mind Centre on appropriate visit days and study compliance will be monitored using a drug diary and help from the caregiver.
Eligibility
Inclusion Criteria3
- Be within 40 to 75 years of age
- Have a diagnosis of behavioural variant frontotemporal dementia, semantic dementia, or progressive non-fluent aphasia
- Have a carer who will be able to live with the participant during the study
Exclusion Criteria10
- Severely compromised cardiac, hepatic or renal function
- Severe nasal obstruction/blockage
- Sensitivity to preservatives (in particular benzyl alcohol 0.9%), which are present in the nasal spray formulation
- Upcoming surgery, due to concerns of interactions with other medications
- Prior history of psychiatric disorders (e.g. major depression, schizophrenia, bipolar disorder)
- Prescribed an anticholinesterase medication for less than three months or are experiencing side effects secondary to this class of medication.
- Have prior history of neurological disorder other than dementia (e.g., head injury, stroke or transient ischemic attack, epilepsy)
- Have a diagnosis of another neurodegenerative disease (e.g., Dementia with Lewy Bodies, Alzheimer’s Disease, Parkinson’ Disease)
- Have an intellectual disability
- Have a current history of substance abuse
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Interventions
Twice-daily administration of 24IU Oxytocin Nasal Spray (generic). Molecular Formula: C43H66N12O12S2 Molecular Weight: 1007.2 CAS Registry: 50-56-6 Dosage: 24IU administered twice a day (total dosage = 48IU) Duration: 1 week Mode: Intranasal Formulation: A bulk oxytocin solution of 24 IU/50µL will be prepared by mixing oxytocin USP drug substance with a diluent. The diluent will consist of glycerol (2%), sorbitol (2%) benzyl alcohol (0.9%) and water for irrigation. Treatment Regime (3-4 weeks total duration) The cross-over study design will implement two arms with alternating intervention regimes which participants will be randomly assigned to. Arm 1: 24 IU Oxytocin administered for 1 week, followed by a 1 week washout period and then placebo administered for 1 week Arm 2: Placebo administered for 1 week, followed by a 1 week washout period and then 24 IU Oxytocin administered for 1 week Intervention period: one week Washout period: one week Research Visits Visit 0: Informed consent session, medical assessment, ECG and blood pathology to confirm eligibility prior to enrolment. Baseline primary and secondary outcome measures may be assessed at this visit. Visit 1 (time point 0 and 1 - Day 1): Single-dose administration of first intervention followed by assessment of relevant primary and secondary outcome measures. Intranasal bottle and instructions provided for first intervention period. Visit 2 (time point 2 - Day 7): Post intervention period follow-up. Monitoring and assessment of primary and secondary outcomes measures. Collection of intranasal bottle from first intervention period. Visit 3 (time point 3 and 4 - Day 14): Post washout period, primary and secondary outcome measures assessed for baseline prior to single-dose administration of second intervention. Single-dose administration of alternate intervention followed by assessment of relevant primary and secondary outcome measures. Intranasal bottle and instructions repeated for second intervention period. Visit 4 (time point 5 - Day 21): Post intervention period follow-up. Monitoring and assessment of primary and secondary outcomes measures. Collection of intranasal bottle from second intervention period. Note: Follow-up calls will be made between 3-5 days into the intervention periods. Final follow-up phone calls will be made 3-5 days after the final visit. Interventional adherence and participant compliance will be monitored using a side effect monitoring diary that the participant and/or carer will maintain throughout the intervention period. Research staff will further monitor compliance during clinic visits using monitoring logs.
Locations(1)
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ACTRN12618001807246