An observational study in Mild Cognitive Impairment (MCI), sponsored by Xuanwu Hospital, Beijing. Recruiting at 1 site in China. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Xuanwu Hospital, Beijing · Observational
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.
This prospective, longitudinal observational cohort study will characterize multidimensional biomarker profiles across the cognitive continuum. Its principal aim is to develop integrated approaches for disease classification and prediction of progression from mild cognitive impairment (MCI) to dementia.
The study will enroll 600 participants in three cohorts: approximately 200 cognitively unimpaired participants, 200 participants with mild cognitive impairment, and 200 participants with dementia. The mild cognitive impairment and dementia cohorts may include Alzheimer disease-related and non-Alzheimer disease-related clinical subtypes, without fixed enrollment quotas for these subtypes. No therapeutic intervention will be assigned.
Baseline evaluations will include demographic and clinical characterization, comprehensive neuropsychological testing, and blood collection. Participants will also undergo multimodal neuroimaging.
Blood-based analyses will assess established and exploratory biomarkers. Established measures will include amyloid beta 42 and phosphorylated tau 217. These biomarkers will be evaluated using chemiluminescent enzyme immunoassay, electrochemiluminescence immunoassay, immunoprecipitation-mass spectrometry, and single-molecule array platforms. Exploratory analyses will examine protein biomarkers, microRNA expression profiles, and lipid-metabolomic markers. Apolipoprotein E genotype will also be determined.
Blood collection, neuropsychological testing, and neuroimaging will be repeated at 12 months. Cross-sectional analyses will compare biomarker profiles across the study groups. Longitudinal analyses will characterize changes in cognition, circulating biomarkers, and neuroimaging measures.
Associations among blood biomarkers, neuroimaging measures, and clinical phenotypes will be examined using prespecified statistical methods. Multivariable statistical and machine-learning approaches will then be used to identify informative combinations of clinical, cognitive, genetic, blood-based, and neuroimaging features. These features will be incorporated into diagnostic and risk-prediction models for MCI, dementia, and progression from MCI to dementia.
3,930 studies on the registry are indexed under Cognitive Dysfunction; 1,114 are open to participants now.
This study's planned enrollment of 600 is above the median of 150 across 989 observational studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →Xuanwu Hospital, Beijing is the lead sponsor of 357 studies on the registry; 226 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population will comprise approximately 600 participants recruited from the memory clinic, neurology outpatient clinics, inpatient wards, and surrounding communities associated with Xuanwu Hospital, Capital Medical University. The planned sample will include approximately 200 cognitively unimpaired participants, 200 participants with mild cognitive impairment, and 200 participants with dementia. Participants with mild cognitive impairment and dementia may include Alzheimer disease-related and non-Alzheimer disease-related clinical subtypes. Diagnostic classification will be established by a trained clinical team in accordance with the approved study protocol.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
General criteria:
Dementia cohort:
Mild cognitive impairment cohort:
Cognitively unimpaired cohort:
Exclusion Criteria:
This cohort will include approximately 200 participants aged 50 years or older who are cognitively unimpaired at baseline. Participants will be recruited primarily from the surrounding community and will undergo clinical evaluation, neuropsychological assessment, blood collection, and multimodal magnetic resonance imaging at baseline and at the 12-month follow-up.
Other: Observational Multimodal Assessment
This cohort will include approximately 200 participants with mild cognitive impairment diagnosed by a consensus panel of three senior neurologists. The cohort may include participants with Alzheimer disease-related and non-Alzheimer disease-related mild cognitive impairment. Participants will undergo clinical evaluation, neuropsychological assessment, blood collection, and multimodal magnetic resonance imaging at baseline and at the 12-month follow-up.
Other: Observational Multimodal Assessment
This cohort will include approximately 200 participants with dementia diagnosed by a consensus panel of three senior neurologists. The cohort may include Alzheimer disease dementia and non-Alzheimer disease dementias. Participants will undergo clinical evaluation, neuropsychological assessment, blood collection, and multimodal magnetic resonance imaging at baseline and at the 12-month follow-up.
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.
Progression From Mild Cognitive Impairment to Dementia
The number and proportion of participants with mild cognitive impairment at baseline who are diagnosed with dementia during or at the 12-month follow-up will be determined. Progression will be adjudicated by a consensus panel of three senior neurologists on the basis of clinical symptoms, neuropsychological assessment, functional status, and a Clinical Dementia Rating score of 1 or higher, in accordance with the approved study protocol.
Time frame: Baseline to 12 months
Change in Cognitive Performance
Changes from baseline to the 12-month follow-up in neuropsychological measures of immediate memory, delayed recall, language, and executive function will be assessed using the protocol-specified neuropsychological assessments.
Time frame: Baseline and 12 months
Plan to share: No — Individual participant data will not be made publicly available because the study dataset contains sensitive clinical, neuroimaging, biomarker, and genetic information and is subject to the approved informed consent, ethics requirements, and applicable Chinese regulations governing human genetic resources and data security. Aggregate study findings may be disseminated through peer-reviewed publications and scientific presentations.
No publications or documents are linked to this record.
Started Jan 2026 (actual). Primary completion is estimated for Dec 2028, 35 months after the start.
Of 515 non-industry observational studies under Cognitive Dysfunction, half reached primary completion within 51 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 124. This study's planned 35 months is below that.
Counting every sponsor, half of 551 studies reached it within 48 months; a quarter within 21 and three quarters within 118.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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