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A Prospective Cohort Study of Multimodal Biomarkers and Progression From Mild Cognitive Impairment to Dementia

StatusRecruiting
PhaseNot specified
Started
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Record History

  1. Minor Study First Submitted
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.
Trial Details
NCT Number NCT07876570
Lead Sponsor Xuanwu Hospital, Beijing
Collaborators: Harbin Medical University, Chinese Academy of Sciences, Beijing Pason Pharmaceuticals Inc
Conditions
(from sponsor)
Mild Cognitive Impairment (MCI)
Related terms Alzheimer Disease, Cognitive Dysfunction, Dementia, Disease Progression
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov