Mild Cognitive Impairment (MCI)NCT07876570
A Prospective Cohort Study of Multimodal Biomarkers and Progression From Mild Cognitive Impairment to Dementia
An observational study of Mild Cognitive Impairment (MCI), run by Xuanwu Hospital, Beijing at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment (MCI)
- What is being tested?
- Observational Multimodal Assessment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 31 Dec 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- General criteria:
- Age 50 years or older.
- Male or female.
- Able and willing to comply with the study assessments and follow-up procedures.
- Able to provide written informed consent, or written informed consent is provided by a legally authorized representative when applicable.
- Dementia cohort:
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- Diagnosis of dementia established by consensus among three senior neurologists with experience in cognitive disorders.
- Clinical Dementia Rating score of 1 or higher.
- Availability of a Chinese-speaking caregiver who can provide information about the participant's clinical condition and who lives with or has contact with the participant for at least 4 days per week.
- Mild cognitive impairment cohort:
- Diagnosis of mild cognitive impairment established by consensus among three senior neurologists with experience in cognitive disorders.
- Clinical Dementia Rating score of 0.5.
- Availability of a Chinese-speaking caregiver who can provide information about the participant's clinical condition and who lives with or has contact with the participant for at least 4 days per week.
- Cognitively unimpaired cohort:
- No history of a major neurological or psychiatric disorder.
- Clinical Dementia Rating score of 0.
Who cannot join
- An acute neurological disorder, including acute stroke, or another medical or neurological condition that would prevent valid assessment of cognitive status.
- A severe psychiatric disorder that would interfere with cognitive assessment or study participation.
- Terminal malignant disease or another severe medical condition that would prevent completion of the study procedures.
- Severe visual or hearing impairment that would interfere with neuropsychological assessment.
- Inability or unwillingness to complete the planned 12-month follow-up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
Qi Qin, MD, PhD, 17610103567, qinqibao@126.com
Qi Qin, MD, PhD
About this study
Official title: A Prospective Multimodal Cohort Study of Cognitive Impairment and Progression From Mild Cognitive Impairment to Dementia
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).
Read more
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.
Read the detailed description
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.
- Conditions
- Mild Cognitive Impairment (MCI)
- Being tested
- Observational Multimodal Assessment
- Keywords
- Mild Cognitive Impairment, Cognitive Impairment, Dementia, Alzheimer Disease, Blood Biomarkers, Disease Progression, Risk Prediction, Artificial Intelligence, Neuropsychological Assessment
- Medical subject headings
- Cognitive Dysfunction, Dementia, Alzheimer Disease, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational Multimodal AssessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitively Unimpaired Cohort | 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. Receives: Other: Observational Multimodal Assessment | |
| Mild Cognitive Impairment Cohort | 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. Receives: Other: Observational Multimodal Assessment | |
| Dementia Cohort | 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. Receives: Other: Observational Multimodal Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 12 months
Secondary outcomes (1)
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.
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start1 Jan 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- Harbin Medical University, Chinese Academy of Sciences, Beijing Pason Pharmaceuticals Inc
- Responsible party
- Sponsor
- Investigators
- Qin Qi, MD, PhD, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07876570
- Sponsor's protocol ID
- 2025471
- Other IDs
- 2025YFE0206600
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.