Examination of safety of oxytocin for patients with Alzheimer's disease dementia.

JRCT ID: jRCTs061200039

Registered date:25/12/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Alzheimer disease dementia
• Date of first enrollment: 25/12/2020
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Oxytocin nasal spray, 24 IU once, twice daily for 8 days

Outcome(s)

• Primary Outcome: Harmful reduction

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 50age old
• Age maximum: <= 80age old
• Gender: Both

Include 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

Exclude 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 (< 50bpm)
12. Prolonged QT interval (> 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

Related Information

• Primary Sponsor: TERADA Seishi