A Study to Evaluate the Efficacy and Safety of Brain Polypeptide Solution in Mild Alzheimer's Disease

This is an interventional treatment trial for Alzheimer Disease focused on measuring Alzheimer Disease, Brain polypeptide Read More

Inclusion Criteria:

1. Age range from 50 to 85 (including 50 and 85 years old), regardless of ethnic group or gender;
2. The subjects should be able to complete the cognitive ability measurement and other tests specified in the protocol;
3. meeting the criteria for likely Alzheimer's Disease （AD） dementia (2007) by National Institute of Neurological Disorders and Strokes - Alzheimer's Disease and Related Diseases Association（NINCDS-ADRDA）;
4. patients with mild dementia: the total score of Mini-Mental State Examination (MMSE) : illiteracy ≤17 points, primary school ≤20 points, secondary school ≤22 points, university ≤23 points; Clinical Dementia Rating scale （CDR） = 1 point;
5. the total score of the Hachinski Ischemic Score （HIS ）was < 4.
6. Hamilton depression scale (17 items) total score ≤7 points;
7. Brain MRI shows a high likelihood of AD;
8. before enrollment, patients should take a stable dose of dementia drugs (such as donepezil 10mg) ≥8 weeks;
9. the expected survival time is > 1 year;
10. subjects should have a stable and reliable caregiver, or at least have frequent contact with the caregiver (at least 3 days per week and at least 2 hours per day), who will help patients participate in the whole study; Caregivers must accompany the subjects to the visit and assist in completing the relevant scale.

Exclusion Criteria:

1. refuse to sign the inform consent form;
2. other causes of dementia: known vascular, central nervous system infection ,Parkinson's disease, traumatic brain dementia, other physical and chemical factors; serious body disease , intracranial space-occupying lesions, endocrine system disease, such as thyroid disease, and a lack of vitamin B12, folic acid, or any other known causes of dementia.
3. central nervous system diseases (including stroke, optic neuromyelitis, Parkinson's disease, epilepsy, etc.);
4. obvious positive signs of nervous system examination;
5. psychotic patients, including schizophrenia or other disorders with bipolar disorder, major depression or delirium;
6. uncontrolled hypertension or hypotension during screening: systolic blood pressure ≥180（millimetres of mercury ）mmHg or < 90mmhg, or diastolic blood pressure ≥120mmHg or < 60mmhg;
7. unstable or severe diseases of the heart, lung, liver, kidney and hematopoietic system according to the judgment of the researchers;
8. patients with incurable visual and auditory disorders that cannot complete neuropsychological tests and scales;
9. female subjects who are positive in pregnancy test or breast-feeding and who cannot take effective contraceptive measures or have a birth plan;
10. severe allergy, non-allergic drug reaction or multi-drug allergy history;
11. participated in other clinical trials within 3 months before screening visit;
12. taking any health care products related to brain and brain improvement currently and failing to keep the promise to stop using the above products;
13. other conditions are unsuitable for participating in this study according to the judgement of researchers.