Alzheimer's disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. aged 50 to 90 years; 2. Male/Female; 3. MMSE score more than 10 points and 24 points less than; 4. Possible AD is diagnosis according to the NINCDS-ADRDA standard; 5. There have been imaging scans of the head (CT or MRI) to support the diagnosis of AD, and these imagings were performed within the past six months or before admission; 6. if not otherwise specified, patients with underlying disease before the baseline must remain clinically stable; 7. Clinical laboratory result must be within the normal range, or if abnormal, no clinical significance must be confirmed by clinical investigator; 8. It is allowed to combine with other medication, but not the forbid medication describe in research plan, and if not otherwise specified, the subjects had to accept a stable dose of combined medication for at least 1 months or 5 half-life of drugs (prevail for a longer term) before baseline; 9. Informed consent shall be signed by the patient himself or his legal guardian prior to the screening. 10. subjects must have relatives / caregivers.
Exclusion criteria
Exclusion criteria: 1. History of past illness including those may affect cognitive function, but can be differentiated from AD diseases, such as schizophrenia, depression and Parkinson's disease, multi infarct dementia, cerebral vascular disease caused dementia, Huntington's disease, Pick disease, cortex - striatum - spinal cord degeneration (CJD), Lewy body disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, epilepsy, subdural hematoma or multiple sclerosis, and the following illness or in any of the following conditions: the subjects suffered from human immunodeficiency virus disease, neurosyphilis, or structural abnormalities in the brain known or persistent neurological defects the head after severe trauma; 2. Suffer from active or uncontrolled epilepsy, asthma, central nervous system infections, other neurodegenerative diseases, and other advanced severe progressive instability diseases; 3. Subjects suffered from dementia and were accompanied by other organic diseases, or AD accompanied by delirium (according to the DSM-IV standard); 4. Serious disability can not meet the needs of clinical research (such as blindness, severe deafness, communication, serious language disorders, not communication); 5. Improved Hachinski ischemia index scale (MHIS) score > 4; 6. Allergic to white protein preparations; 7. Less than 40 kg in weight; 8. Pregnant or lactating women (pregnant defined as the period including pregnant to the termination of pregnancy, laboratory tests show positive urine HCG); 9. Women of reproductive age plan pregnant during the study period; 10. Patients with abnormal liver function. Elevated transaminase is considered clinically significant; 11. Patients with severe renal impairment; 12. Severe biliary obstruction.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ADAS-Cog; | — |
Secondary
| Measure | Time frame |
|---|---|
| MMSE;ADCS-ADL;NPI;CDR-SB; | — |
Countries
China
Contacts
Guangzhou Huiai Hosptial (The Affiliated Brain Hospital of Guangzhou Medical University)