Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-24 @ 7:38 PM
NCT ID:
NCT02982603
Eligibility Criteria:
Inclusion Criteria:
1. cognitive complaints from the patients or their families;
2. objective evidence for memory impairment, delayed story recall test(DSR)\<12.6(age50-64 less than15.5,65-74less than 12.5,older 75 less than10);
3. normal general cognitive function, with Mini-Mental State Examination (MMSE) score of between 24 and 30 (including 30);
4. preservation of activities of daily living, with Alzheimer's Disease Cooperative Study/Activities of Daily Living scale adapted for MCI patients (ADCS/MCI/ADL24) score between 38 and 52;
5. cognitive disorders as evidenced by clinical evaluation, with clinical dementia rating scale=0.5,memory domain = 0.5;
6. absence of dementia, not sufficiently impaired cognitively and functionally to meet DSM-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 study procedures.
Exclusion Criteria:
1. non amnestic Mild cognitive impairment;
2. meeting the diagnostic criteria for dementia;
3. cognitive impairment resulting from conditions such as acute cerebral trauma, cerebral damage due to a lack of oxygen, epilepsy vitamin deficiency, infections such as meningitis or AIDS, significant endocrine or metabolic disease, mental retardation, or a 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 lesions within 12 months，the Hachinski Ischemic Scale (HIS)\>4;
5. combined following disease: diabetes; poor controlled hypertension or severe arrhythmias; 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 of the kidney or liver;
10. vegetarians or contraindications for animal innards.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
85 Years
Study:
NCT02982603
Study Brief:
Protocol Section:
NCT02982603