Efficacy and Safety of 1612 Capsules in aMnestic Mild Cognitive Impairment

Inclusion Criteria: Patients should be enrolled if they met the following criteria[14]:

1. cognitive complaints from the patients or their families;
2. objective evidence for memory impairment, delayed story recall test(DSR)<12.6(age50-64less than15.5,65-74less than 12.5,older 75 less than10);
3. normal general cognitive function, with Mini-Mental State Examination (MMSE) score ofbetween 24 and 30 (including 30);
4. preservation of activities of daily living, with Alzheimer's Disease CooperativeStudy/Activities of Daily Living scale adapted for MCI patients (ADCS/MCI/ADL24) scorebetween 38 and 52;
5. cognitive disorders as evidenced by clinical evaluation, with clinical dementia ratingscale=0.5,memory domain = 0.5;
6. absence of dementia, not sufficiently impaired cognitively and functionally to meetDSM-IV criteria,
7. enough vision and hearing to accomplishment neuropsychological test;
8. capability to read words and write simple sentence;
9. capability and willingness to give informed consent and to comply with the studyprocedures.

Exclusion Criteria: The patients would be ineligible if they had the following conditions:

1. non amnestic Mild cognitive impairment;
2. meeting the diagnostic criteria for dementia;
3. cognitive impairment resulting from conditions such as acute cerebral trauma, cerebraldamage due to a lack of oxygen, epilepsy vitamin deficiency, infections such asmeningitis or AIDS, significant endocrine or metabolic disease, mental retardation, ora brain tumor ,or drug abuse or alcohol abuse
4. having significant psychiatric disease, depression, the Hamilton depression scale >12;CT or MRI scan showed central nervous system infections Infarction or focal lesionswithin 12 months，the Hachinski Ischemic Scale (HIS)>4;
5. combined following disease: diabetes; poor controlled hypertension or severearrhythmias; or suffered from heart infarction within 3 months; severe asthma or COPD;severe indigestion; gastrointestinal tract obstruction; gastroduodenal ulcer;
6. used cholinesterase inhibitors or memantine within 1 month;
7. history of hypersensitivity to the treatment drugs;
8. concomitant drugs with the potential to interfere with cognition;
9. administration of other investigational drugs; severe impairment of the functions ofthe kidney or liver;
10. vegetarians or contraindications for animal innards.