Alzheimer disease dementia dementia
Conditions
Interventions
Sponsors
TERADA Seishi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Over 50 years old, under 80 years old 2. In case that we obtain written informed consent from both the subjects and their guardian, or in case that we confirm their assent from the subjects and obtain written informed consent from their guardian 3. Diagnosed as dementia based on the ICD-10 and DSM-5 criteria 4. Diagnosed as Alzheimer's dementia based on the NIA-AA criteria 5. The Clinical Dementia Rating (CDR) is 0.5 or 1.0. 6. Those who lives with a family member and the family member can confirm and record whether the subjects use the intranasal oxytocin as defined during the study period
Exclusion criteria
Exclusion criteria: 1. Unstable psychiatric symptoms (NPI "agitation/aggression" severity of 2 or more) 2. Socially inappropriate sexual behavior 3. History of changing the psychotropic medication within a month 4. Currently under treatment with two or more psychotropic medications 5. History of oxytocin use within 6 months 6. History of hypersensitivity to oxytocin or latex 7. History of loss of consciousness 8. History of alcohol related disorder or substance abuse 9. History of myocardial infarction within 6 months 10. Uncontrolled hypertension 11. Bradycardia ( 0.45sec) 13. Hyponatremia (<136 mEq/L) 14. Pregnant or lactating women 15. Currently under treatment for or have a history of gynecological disease 16. Currently under treatment for endocrine disease 17. Currently under treatment for cardiovascular disease 18. Currently under treatment with steroids 19. Currently under treatment with prostaglandin 20. Currently under treatment with cyclophosphamide 21. History of participation in other clinical trials within 6 months 22. History of malignancy within 5 years 23. MRI cannot be administered 24. Judged by researcher that participation in research is not in the best interest of the research subject, or the participation of the subject interfere or confuse plan-specific assessments 25. Investigators who are directly involved in this research or other clinical studies, or employees of conducting medical institutions, or families of such employees or investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Harmful reduction | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. dropout rate 2. NPI (Neuropsychiatric Inventory) 3. AES (Apathy Evaluation Scale) 4. VI (Vitality index) 5. ToM (Theory of Mind) 6. ACE-III (Addenbrooke's Cognitive Examination III) 7. ZBI (Zarit Burden Interview) 8. QOL-D (Quality of life questionnaire for dementia) 9. WHO-QOL (WHO Quality of Life) 10. blood levels of oxytocin 11. Vital Signs | — |
Contacts
Public ContactShintaro TAKENOSHITA
Okayama University Hospital
Outcome results
None listed