mild cognitive impairment
Conditions
Interventions
Intervention group:Participants in the intervention group will wear a noninvasive frontal EEG acquisition device while using a digital therapeutics–based cognitive training program. The digital therap
Control group:Participants in the control group will continue their current treatment regimen for 12 weeks. After the 12-week period, they may freely choose whether to use the digital therapeutic inte
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
50 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Male or female participants aged > 50 years at the screening visit; 2. Diagnosis of amnestic mild cognitive impairment (aMCI) as defined by the 2018 Chinese guidelines, confirmed by two experienced neurologists based on clinical evaluation and neuropsychological testing, including: Memory complaints or clinical symptoms reported by the participant or an informant; CDR = 0.5; Objective decline in one or more cognitive domains on cognitive testing; Mild impairment in complex instrumental activities of daily living (IADL), with preserved independence in basic activities of daily living (ADL); Not meeting diagnostic criteria for dementia; 3. MoCA (Beijing version) score between 10 and 25 (inclusive); 4. Stable doses for >= 4 weeks prior to enrollment of medications that may affect cognition/mood/arousal, with no changes planned during the study period; 5. Access to an internet-connected computer or tablet and ability to use it independently.
Exclusion criteria
Exclusion criteria: 1. Any prior diagnosis of dementia, or severe central nervous system diseases that may cause cognitive impairment (e.g., stroke, intracranial tumor, intracranial infection, Parkinson’s disease, etc.); 2. Severe and unstable psychiatric disorders (e.g., major depressive disorder with high suicide risk, psychotic disorders, acute phase of bipolar disorder), or a recent episode of substance use disorder; 3. Severe dysfunction of major organs (heart, lung, liver, kidney, etc.), including but not limited to: severe cardiovascular disease (e.g., hospitalization for myocardial infarction or cardiac surgery within the past 3 months, congestive heart failure, history of myocardial infarction, severe unstable arrhythmia, hypertrophic cardiomyopathy, severe aortic stenosis, aneurysm, etc.), severe pulmonary disease (e.g., severe pneumonia, respiratory failure), hepatic insufficiency (ALT/AST > 3× the upper limit of normal), renal insufficiency (creatinine or blood urea nitrogen > 1.5× the upper limit of normal), malignant tumors, or any other condition deemed by the investigator to make the participant unsuitable for this clinical trial; 4. Initiation or adjustment of CBT-I or other active treatment within the past 4 weeks, or planned receipt of CBT-I during the study period; 5. Initiation of cognitive-enhancing medications within 4 weeks prior to enrollment without reaching a stable regimen, or planned medication changes during the study; 6. Allergy to adhesive electrodes, or active skin lesions on the auricle or scalp; 7. History of intracranial or in-body metallic implants or devices (excluding dental metal implants), such as pacemakers/defibrillators, drug pumps, neurostimulators, cochlear implants, etc.; 8. Participation in another clinical trial within 3 months prior to enrollment or current participation in another clinical trial; 9. Any other condition that, in the investigator’s judgment, makes the participant unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Montreal Cognitive Assessment,MoCA; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Dementia Rating, CDR;Generalized Anxiety Disorder Scale -7 items;Patient Health Questionnaire-9;Magnetic Resonance Imaging;biomarker; | — |
Countries
China
Contacts
Public ContactLei Chen
West China Hospital, Sichuan University
Outcome results
None listed