Alzheimer‘s Disease
Conditions
Interventions
Group A:GV-971
Group B:Vehicle
Group C:GV-971+Donepezil
Group D:Vehicle+Donepezil
Sponsors
The First Affiliated Hospital of University of Science and Technology of China
Eligibility
Sex/Gender
All
Age
50 Years to 79 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 50 and 79 years old; 2. Both male and female; 3. Years of education >= 5 years; 4. The clinical dementia scale score is 0.5, and the memory module is at least 0.5; 5. MMSE score =12; 6. 18F-AV45-PET was positive or cerebrospinal fluid Abeta and tau detection showed AD-like changes; 7. No related drugs for AD symptoms have been used in the past 3 months; 8. Have reliable caregivers, meet the subjects at least five days a week, at least three hours a day, accompany the patients throughout the study, and be familiar with the subjects' health and personal care; 9. Patients and caregivers signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Those with cognitive impairment that may be caused by other reasons (vascular, infectious, metabolic, immune); 2) Those with fluctuating mental illness; 3. Those with abnormal cardiovascular and cardiac function; 4. Those with obvious respiratory system dysfunction; 5. Patients with abnormal renal function and liver function; 6. Those who clearly have coagulation disorders and tumor-related diseases; 7. Alcohol or drug abusers in the past 1 year; 8. Combination of drugs: other cognitive-improving drugs, such as other anticholinesterase inhibitors, memantine, Chinese patent medicines, etc., were taken during the treatment period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Dementia Rating Scale Overall Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Simple Mental State Examination Scale;Alzheimer's Disease Rating Scale - Cognitive Subscale;Alzheimer's Disease Activities of Daily Living Inventory; | — |
Countries
China
Contacts
Public ContactShen Yong
The First Affiliated Hospital of University of Science and Technology of China
Outcome results
None listed