Alzheimer‘s disease
Conditions
Interventions
Observation Group:None
Sponsors
Xuanwu Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
50 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Clinical Setting: Patients visiting the memory clinic, referred by the cognitive center, or already enrolled in the existing high-level innovation center ward cohort for neurological diseases. 2. Demographics: Aged between 50 and 90 years at the time of registration, regardless of gender. 3. Cognitive Status: Diagnosed with Subjective Cognitive Decline (SCD) or Mild Cognitive Impairment (MCI), with a Clinical Dementia Rating–Global Score (CDR-GS) of 1.5 SD below normative means), while functional independence is essentially preserved. 4. Biomarker Data: Availability of diagnostic biomarker records (e.g., blood or cerebrospinal fluid [CSF] biomarker results, or imaging data) within one year prior to the recruitment date. 5. Education: Literate, or having received formal education for 4 to 6 years or more. 6. Technical Capability: Possess the cognitive capacity to operate devices and follow automated voice prompts, and be able to complete the tablet-based speech assessment independently without supervision. 7. Language: Fluent in Mandarin Chinese, capable of understanding informed consent materials and completing oral assessments. 8. Consent: Willing to participate in this clinical trial, capable of providing independent informed consent, and able to sign a fully dated informed consent form.
Exclusion criteria
Exclusion criteria: 1. Hearing Impairment: Significant hearing impairment that interferes with speech tasks or interactive AI assessments; 2. Systemic Health: Presence of severe, unstable systemic diseases or organ failure that precludes participation in the study; 3. Substance Abuse: Current severe alcohol or substance abuse; 4. Etiology of Impairment: Cognitive impairment clearly attributable to non-AD conditions, including severe anemia, acute infection, severe sleep deprivation, psychotic disorders, or moderate-to-severe depression; 5. Device Usage: Significant deficits preventing the independent use of tablet devices, or inability to follow automated digital prompts even after preliminary instruction; 6. Consent & Data: Refusal to participate in the examination or to share data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Correlation between speech metrics and neuropsychological test results and related biomarkers; | — |
Secondary
| Measure | Time frame |
|---|---|
| SB-C score performance across different diagnostic groups (SCD, MCI);Sensitivity, specificity, and overall diagnostic performance (AUC) of SB-C score in identifying high-risk Alzheimer's disease phenotypes (SCD, MCI);Psychometric validity (reliability and consistency) of unsupervised, self-administered tablet-based speech cognitive tasks;Participant acceptability and trust in the digital assessment tool; | — |
Countries
China
Contacts
Public ContactTang Yi
Xuanwu Hospital Capital Medical University
Outcome results
None listed