None listed
Conditions
Brief summary
People with dementia often experience difficulty in recognising the emotions of other people, such as fear, anger and sadness. This can impact upon relationships and social interactions thus causing distress for the individual living with dementia as well as for family members and friends. This study investigates whether a naturally occurring hormone in the body, oxytocin, can help people with Alzheimer's disease and/or Vascular dementia recognise the emotions of other people better. It is hypothesised that patients who receive the oxytocin nasal spray will demonstrate improved accuracy of emotion recognition, following a single dose and repeated administration over one week. Furthermore, it is also hypothesised carers of patients who receive the oxytocin nasal spray will report improved interactions and reduced caregiver burden.
Interventions
In this 1 week, double-blind, randomised, placebo controlled crossover trial, all participants will be randomised to either an intranasal administered oxytocin (72 IU; One 36 IU doses of oxytocin/placebo per nostril twice daily) or placebo nasal spray (one dose per nostril twice daily) for one week. This is followed by a one week washout period and a further one week crossover period with the alternative medication.
Intervention adherence will primarily be monitored using a chart completed by t
In this 1 week, double-blind, randomised, placebo controlled crossover trial, all participants will be randomised to either an intranasal administered oxytocin (72 IU; One 36 IU doses of oxytocin/placebo per nostril twice daily) or placebo nasal spray (one dose per nostril twice daily) for one week. This is followed by a one week washout period and a further one week crossover period with the alternative medication. Intervention adherence will primarily be monitored using a chart completed by the carer of the participant living with dementia, after each administration. Additionally, participants will be required to return empty medication packets at the end of each intervention week whereby the investigators will measure nasal-spray bottle weight to elucidate drug adherence
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
60 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
To be eligible participants must: 1. 60 to 90 years of age 2. Have a diagnosis of mild AD, Vascular Dementia or mixed AD / Vascular Dementia (MMSE >= 20) 3. Have a carer who will be able to live with the participant during the study
Exclusion criteria
Participants will be excluded if they: 1. Have prior history of psychiatric disorders (e.g. major depression, schizophrenia, bipolar disorder) 2. Have a score of =< 40 on the Benton Facial Recognition Test 3. Have a score on the 18-item Hamilton Depression Rating Scale greater than 16 4. Have been prescribed an anticholinesterase medication for less than three months or are experiencing side effects secondary to this class of medication. 5. Have been prescribed an antidepressant medication for less than one month or if they are experiencing side effects related to this medication or if the particular antidepressant is contraindicated with an INOT intervention 6. Currently prescribed any of the following classes of medications: non-anticholinesterase medications for dementia, antipsychotics, benzodiazepines, sedatives, and hypnotics 7. Have prior history of neurological disorder (e.g., head injury, stroke or transient ischemic attack, epilepsy) 8. Have a diagnosis of another neurodegenerative disease (e.g., Dementia with Lewy Bodies, Frontotemporal Dementia, Parkinson’ Disease Dementia) 9. Have an intellectual disability 10. Have a current history of substance abuse 11. Has a history of a myocardial infarction within the last two years or congestive heart failure 12. Current uncontrolled hypertension 13. Current bradycardia (rate < 50 beats per minute/bpm) or tachycardia (rate > 100 bpm) 14. Has a diagnosis of long QT syndrome 15. Current use of prostaglandins and their analogues 16. Current use of any anaesthetic (inhalation or caudal) 17. Known allergies to oxytocin or to preservatives in the nasal spray 18. Participants with severe nasal obstruction/blockage 19. Participants with severely compromised hepatic function 20. Participants with severely compromised renal function
Outcome results
None listed