A study of effects on cognitive function and neuropsychiatric symptoms in patients with mild to moderate Alzheimer's disease
- Conditions
- Cognitive function and neuropsychiatric symptoms in patients with mild to moderate Alzheimer's diseasePericarp mangosteen extract, Alzheimer'
- Registration Number
- TCTR20170509001
- Lead Sponsor
- Department for Development of Thai Traditional and Alternative Medicine, Ministry of Public Health
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 180
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.
Phase II
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
4.The subjects are currently afflicted with a psychiatric disease which could interfere with the evaluation of the study result. If the neuropsychiatric problems are from dementia, the subjects can be recruited.
5.Known case of human immunodeficiency virus (HIV) infection. If the HIV status is unknown, the HIV test is not necessary.
6.No reliable informant
7.Screening laboratory results are abnormal in the following criteria
- Absolute Neutrophils Count (ANC) < 2x109 /L
- Platelet <100 x109 /L
- AST/ALT>2.5 x upper limit
- Bilirubin >1.5x upper limit
- Blood urea nitrogen >1.5x upper limit or creatinine clearance <30 mL/min (CKD-Epi formula)
8.Use of the following drugs within 30 days before recruitment
a)narcotics use more than two times/week
b)Low potency antipsychotics (e.g., chlorpromazine, thioridazine)
c)Drugs with high anticholinergic activity such as tricyclic antidepressants
d)Antiparkinson drugs (eg selegiline, levodopa, amantadine)
e)Short-acting insulin
f)Lithium
g)Clozapine
h)Bupropion
If the subjects have used sedatives/anxiolytics or atypical/high potency antipsychotic drugs before recruitment, the dose must not be adjusted within 30 days before the study entry.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy of pericarp mangosteen extract 24 weeks neuropsychological assessment ,safety of pericarp mangosteen extract 24 weeks laboratory test, clinical data
- Secondary Outcome Measures
Name Time Method tolerability 24 WEEKS adherence, side effect