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 @ 11:24 PM
Ignite Modification Date:
2025-12-24 @ 11:24 PM
NCT ID:
NCT04063956
Eligibility Criteria:
Inclusion Criteria:
1. Literate Han Chinese, 50-85 years of age with a caregiver that accompanies the subject consistently at least 4 days a week;
2. Complaint and/or informant report of a cognitive impairment lasting for at least 3 months;
3. Clinical diagnosis of MCI according to the MCI core clinical criteria of the National Institute on Aging-Alzheimer's Association (NIA-AA) guidelines;
4. A prominent manifestation of memory deficit with or without other cognitive domain impairments;
5. Mini-Mental State Examination (MMSE) score ≥24, and Clinical dementia rating (CDR) = 0.5, and
6. Normal or slightly impaired activities of daily living as defined by a total score of ≤ 1.5 on the three functional CDR domains (home and hobbies, community affairs, and personal care).
Exclusion Criteria:
1. Severe aphasia, physical disabilities, or any other disease that may preclude completion of neuropsychological testing;
2. A medical history of stroke with focal neurological features including hemiparesis, sensory loss, visual field deficits, and evidence of responsible lesions on MRI;
3. Significant white matter lesions (Fazekas score = 3-6);
4. Disorders other than aMCI that may affect cognition;
5. Depression or other psychiatric disorders;
6. Clinically significant gastrointestinal, renal, hepatic, respiratory, infectious, endocrine, or cardiovascular diseases, cancer, alcoholism, drug addiction;
7. Use of medications that may affect cognitive functioning, including tranquilizers, anti-anxiolytics, hypnotics, nootropics, and cholinomimetic agents;
8. Inability to undergo a brain MRI; and
9. Other conditions that in the investigator's opinion might not be suitable for the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
85 Years
Study:
NCT04063956
Study Brief:
Protocol Section:
NCT04063956