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RECRUITING
NCT07876570

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

Sponsor: Xuanwu Hospital, Beijing

View on ClinicalTrials.gov

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.

Official title: A Prospective Multimodal Cohort Study of Cognitive Impairment and Progression From Mild Cognitive Impairment to Dementia

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

OBSERVATIONAL

Enrollment

600

Start Date

2026-01-01

Completion Date

2028-12-31

Last Updated

2026-10-15

Healthy Volunteers

Yes

Interventions

OTHER

Observational Multimodal Assessment

No therapeutic intervention will be assigned. Participants will undergo protocol-specified clinical and neuropsychological assessments, blood collection and biomarker testing, and multimodal magnetic resonance imaging at baseline. These assessments will be repeated at the 12-month follow-up using the same standardized procedures.

Locations (1)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, China