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Clinical Trials/ACTRN12617001531303
ACTRN12617001531303
Terminated
Phase 4

Pilot study: Intranasal oxytocin administration as a potential symptomatic intervention treatment to improve emotion recognition in patients with dementia

niversity of Sydney0 sites4 target enrollmentNovember 3, 2017

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Alzheimer's disease
Sponsor
niversity of Sydney
Enrollment
4
Status
Terminated
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 3, 2017
End Date
August 19, 2019
Last Updated
4 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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