Alzheimer's
Conditions
Keywords
Ginkgo biloba dispersible tablets, Alzheimer's
Brief summary
This project explores Ginkgo biloba ester dispersible tablets influence on cognitive function in patients with mild-to-moderate elderly, to observe the effects of different intervention time on cognitive function, for alzheimer's patients in drug rehabilitation treatment provides an effective solution.
Detailed description
The assessment of cognitive scales included Minimum Mental State Examination(MMSE), Alzheimer's Disease Assessment Scale-cognition(ADAS-cog), Neuropsychiatric inventory(NPI), quality of Life of Life in Alzheimer's disease(Qol-ADL), activities of Daily living(ADL), Geriatric Depression scale(GDS).Biochemical test included cholesterol, triglycerides, and low density lipoprotein.
Interventions
DRUGGinkgo biloba dispersible tablets
Arm C：Ginkgo biloba dispersible tablets，0.15g at a time， three times a day.
DRUGDonepezil
Arm A：Aricept 5mg/day
DRUGGinkgo biloba dispersible tablets and Donepezil
Arm B：Ginkgo biloba dispersible tablets，0.15g at a time， three times a day.Aricept 5mg/day.
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. All patients were diagnosed with dementia caused by AD in 2011, the latest diagnostic criteria for Alzheimer's disease (NIA-AA), according to the patient's clinical and cranial imaging findings 2. Improved Hachinski ischemic scale score \<4 3. All patients underwent head CT and / or MRI examinations and laboratory tests to rule out other causes of dementia 4. MMSE(High school≤24,Primary school≤20;illiteracy≤17) 5. CDR 1-2 6. The subjects and nurses signed informed consent, and the nursing staff were able to take responsibility for the supervision of the participants 7. The subjects were stable 8. Cooperate, willing to complete all parts of the research, and have the ability to complete the study alone or with the help of the nursing staff 9. To cooperate with the study, do not live alone, such as living alone should keep in touch with the nurse every day.
Exclusion criteria
1. Heart lung kidney disease, may interfere to evaluate the efficacy and safety of patients at risk or special disease,for example:Congestive heart failure et al. 2. According to NINDS-AIREN standard (Roman GC et al 1993) is currently diagnosed as possible vascular dementia 3. Improved Hachinski ischemic scale score（MHIS）≥4 4. Diagnosis of severe depression, schizophrenia, and other major neurodegenerative disorders, according to the DSM-IV axis 5. Neurological or other medical disorders that affect the function of the central nervous system,like Moderate anemia,Vitamin B12 or folic acid deficiency, et al. Not with the cognitive function examination (including blindness, deafness, severe language disorders).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| renal function | change from baseline at 12weeks | blood urea nitrogen |
| Scales to assess | change from baseline MMSE at 12weeks | MMSE（Mini-mental State Examinatlon） |
| Electroencephalography P300 | change from baseline at 12weeks | participants distinguish two voice and count them at the same time.we record their electroencephalography |
| liver function (blood) | change from baseline at 12weeks | liver function（aspartate transaminase，Alanine aminotransferase，low density lipoprotein，Serum total cholesterol，Triglyceride） |
| 1.5T MRI changes | changes before and after 12weeks | Magnetic Resonance Imaging |
| Alzheimer disease assessment scale (ADAS-cog) | change from baseline ADAS-cog at 12 weeks | ADAS-cog |
| activities of daily living scale (ADL) | change from baseline ADL at 12 weeks | ADL |
| Change in neuropsychiatrc interventory (NPI) | change from baseline NPI at 12weeks | NPI |
| Change in geriatric depression scale (GDS) | change from baseline GDS at 12 weeks | GDS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ECG | change from baseline at 12weeks | Electrocardiograph |
Countries
China
Contacts
Primary ContactTing Wu
Outcome results
None listed