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Life sciences · Observational Study
ClinicalTrials.gov · October 15, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT07876570). This is a study registration, not published results. Lead sponsor: Xuanwu Hospital, Beijing. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 600 participants (ESTIMATED). Conditions: Mild Cognitive Impairment (MCI). Interventions: OTHER: Observational Multimodal Assessment. Primary outcome measures: Progression From Mild Cognitive Impairment to Dementia , Baseline to 12 months. Brief summary: This prospective, longitudinal observational cohort study will examine clinical, cognitive, blood-based, and neuroimaging features across the cognitive continuum. It will also assess whether these measures can distinguish disease stages and predict progression from mild cognitive impairment (MCI) to dementia. The study will enroll 600 participants. These will include 200 individuals without cognitive impairment, 200 with MCI, and 200 with dementia. The MCI group will comprise participants with Alzheimer disease-related MCI and non-Alzheimer disease-related MCI. The dementia group will be further characterized by clinical subtype (Alzheimer disease-related versus non-Alzheimer disease-related). At baseline, participants will undergo clinical evaluation, neuropsychological assessment, blood collection, and multimodal magnetic resonance imaging. Neuropsychological assessment, blood collection, and magnetic resonance imaging will be repeated at 12 months. No treatment will be assigned. The analyses will compare biomarker profiles across the study groups and examine relationships among blood biomarkers, neuroimaging findings, and cognitive performance. Clinical, cognitive, genetic, blood-based, and neuroimaging measures will then be integrated to develop diagnostic and risk-prediction models.