Does intranasal oxytocin enhance emotions in dementia?

Phase 4

• Conditions: Alzheimer's disease; Vascular dementia; Neurological - Alzheimer's disease; Neurological - Dementias

• Registration Number: ACTRN12617001531303
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-03
• Study Completion: 2019-08-19
• Last Update Posted: 28 February 2022

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The ability to infer mental states with the Reading the Mind in the Eyes Test. [Pre single dose administration; between 45 and 90 minutes post single dose administration; and at 1 week for each treatment period.];Participant’s perspective-taking as assessed by the carer version of the Interpersonal Reactivity Index. [Pre single dose administration and at 1 week for each treatment period.];Participant’s empathic concern as assessed by the carer version of the Interpersonal Reactivity Index. [Pre single dose administration and at 1 week for each treatment period.]