A study of effects on cognitive function and neuropsychiatric symptoms in patients with mild to moderate Alzheimer's disease

Department for Development of Thai Traditional and Alternative Medicine, Ministry of Public Health0 sites180 target enrollmentMay 9, 2017

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Cognitive function and neuropsychiatric symptoms in patients with mild to moderate Alzheimer&#039
Sponsor: Department for Development of Thai Traditional and Alternative Medicine, Ministry of Public Health
Enrollment: 180
Status: Recruiting
Last Updated: last year

No summary available.

Registry

who.int

Start Date

May 9, 2017

End Date

October 28, 2021

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

Department for Development of Thai Traditional and Alternative Medicine, Ministry of Public Health

•1\) Age \>50 years with the following diagnostic criteria for AD
•\- Diagnostic and Statistical Manual of Mental Disorders\-IV Text Revision (DSM\-IV\-TR)
•\- National Institute of Neurological and Communicative Disorders and Stroke\-Alzheimer's Disease and Related Disorder Associations Criteria (NINCDS\-ADRDA) for probable AD
•\- TMSE score 12\-25
•\- Modified Hachinski Ischemic Score \< 4
•2\. voluntarily participate in the project with the approval of their legal representative
•3\.received the neuroimaging before the recruitment within one year with compatible findings
•4\.if the subjects received acetylcholinesterase inhibitor (donepezil, rivastigmine, galantamine) or NMDA receptor inhibitor (memantine), the dose had to be stable within four months, and there was no plan to adjust the quantity during the study period
•5\. before the subjects suffered AD, they had to be literate and able to communicate with other people
•6\.There had to be reliable caregivers who provided care at least five days per week and at least 3 hours per day. The caregivers had to know the subjects' symptoms regarding ADLS, cognition, and BPSD. The caregivers had to be able to bring the subjects to the study center.

•1\.By clinical and neuroimaging data, there must be no other brain abnormality apart from AD
•2\.Unstable medical illness, which the researchers consider to affect the study protocol or the assessment of the mangosteen side effect.
•a)Disability which could result in the incomplete study follow up such as blindness, deafness, communication problems not from AD
•b)History of cancer within five years, which is considered to be a high chance of recurrence
•c)Systolic blood pressure \<90 mmHg or \>180 mmHg, or heart rate \< 50/min
•d) Malignant arrhythmia
•e) Unstable cardiac conditions such as unstable angina, decompensated heart failure, arrhythmia
•f)History of head injury or stroke with residual neurological deficit
•g)Epilepsy patient who is still on antiepileptic drugs
•3\.other brain diseases result in dementia, such as Parkinson disease dementia, frontotemporal dementia, vascular dementia, Lewy bodies dementia and NPH