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:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-25 @ 2:40 AM
NCT ID:
NCT07208734
Eligibility Criteria:
Inclusion Criteria:
1. Inpatients or outpatients aged 50-90 years;
2. Patients diagnosed with amnestic mild cognitive impairment (aMCI) due to AD or mild dementia due to AD, based on the 2018 NIA-AA clinical diagnostic criteria established by the National Institute on Aging and the Alzheimer's Association;
3. Neuropsychological assessment showing MMSE scores between 18 and 26, and a CDR score of 0.5 or 1;
4. Able to communicate fluently in Chinese (non-illiterate);
5. For those currently receiving cholinesterase inhibitor therapy (e.g., donepezil or rivastigmine), the treatment dose must be stable, defined as a fixed dosage administered continuously for at least six weeks, with no adjustment of the medication regimen during the study period;
6. Provision of written informed consent.
Exclusion Criteria:
1. Documented history of cerebrovascular stroke, with clear neurological deficits at onset and corresponding responsible lesions on neuroimaging;
2. Moderate to severe white matter lesions (Fazekas score 3-6);
3. Presence of any cause of consciousness disorder;
4. Severe aphasia or motor disability that prevents completion of neuropsychological assessments;
5. Current psychiatric disorders;
6. History of alcohol dependence, drug addiction, traumatic brain injury, epilepsy, encephalitis, normal-pressure hydrocephalus, or other neurological disorders that may cause cognitive impairment;
7. Systemic diseases that may contribute to mild cognitive impairment (e.g., hepatic or renal insufficiency, endocrine disorders, vitamin deficiencies);
8. Considered unsuitable for participation by the investigators.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
90 Years
Study:
NCT07208734
Study Brief:
Protocol Section:
NCT07208734