Mild and moderate Alzheimer's disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. No gender limit, subjects aged 60 to 85 years (inclusive) at the time of screening; 2. Willing and able to provide informed consent, provided by or legally authorized representative; 3. Have the listening, speaking, reading, writing and language skills required to participate in all tests; 4. Have a study partner/caregiver who can supervise and assist subjects with cognitive training games on a daily basis, and have in-depth knowledge of subjects' cognitive, functional and emotional states and personal care. The study partner must be willing to accompany the subject on all study visits, ensure that all medications and cognitive training are effectively administered, and report adverse events; 5. Meet the diagnostic criteria for dementia.
Exclusion criteria
Exclusion criteria: 1. Diagnosis of non-AD central nervous system diseases associated with dementia (e.g., Parkinson's disease, Huntington's disease, frontotemporal dementia, dementia with multiple cerebral infarction, dementia with Lewy bodies, normal cranial pressure hydrocephalus); 2. History of folic acid, thyroid, and/or vitamin B12 abnormalities that could not be corrected prior to baseline visit; 3. For major structural encephalopathy diagnosed by MRI in the past (such as ischemic infarction, subdural hematoma, hemorrhage, hydrocephalus, brain tumor, multiple subcortical ischemic lesions or single lesions in key areas (such as thalamus)), if MRI examination is not possible (about 10% of subjects at most), computed tomography (CT) scan can replace the MRI examination standard; 4. Psychiatric disorders identified according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-?) criteria that are unstable within 12 months or would interfere with study evaluation, including schizophrenia or other psychiatric disorders, bipolar disorder, major depression, or delirium; 5. A history of severe arrhythmia, myocardial infarction, transient ischemic attack or cerebrovascular accident, and decompensated congestive heart failure within the past 6 months; 6. The investigator determined that during the 6 months prior to screening, the subject had a major medical condition or unstable medical condition that would interfere with the subject's compliance with study procedures and study restrictions, or with the interpretation of safety data, including any physical disability that might interfere with the completion of study procedures or evaluations (e.g., blindness, hearing loss, non-AD related speech disorders, sensory or motor dysfunction).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Senile Dementia Rating Scale-Cognitive Subscale;Mini-mental State Examination;Montreal Cognitive Assessment Scale;Clinical Dementia Rating Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Functional Activity Questionnaire Score;Rey Auditory Word Learning;Logical Memory;Boston Naming Test;Voice/Semantic Word Fluency Test;Digit Span Test;Trail Making Test A and B;Hamilton Anxiety Scale (HAMA);Hamilton Depression Scale Score;Pittsburgh Sleep Quality Index; | — |
Countries
China
Contacts
Shanghai Yangzhi Rehabilitation Hospital (Shanghai Sunshine Rehabilitation Center)