NCT07876570Recruiting
A Prospective Cohort Study of Multimodal Biomarkers and Progression From Mild Cognitive Impairment to Dementia
A Prospective Multimodal Cohort Study of Cognitive Impairment and Progression From Mild Cognitive Impairment to Dementia
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 600 (estimated)
- First submitted
- 8 Oct 2026
- Start date
- Jan 2026
- Primary completion date
- Dec 2028
- Lead sponsor
- Xuanwu Hospital, Beijing
- Diseases
- Alzheimer disease
- NCT number
- NCT07876570
What you commit to
- Study type: Observational
- Planned participants: 600
- From Jan 2026 to the primary completion date, Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Inability or unwillingness to complete the planned 12-month follow-up.
Who the study is looking for
- 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:
- 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.
Age in the registry: 50 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xuanwu Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.