See if multimodal biomarkers can map changes from mild cognitive impairment to dementia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, longitudinal study will collect clinical data, neuropsychological tests, blood biomarkers, and multimodal MRI to characterize biomarker profiles across the cognitive spectrum. It aims to develop integrated methods to classify disease stage and forecast progression from MCI to dementia. No treatment will be given; participants are followed for at least 12 months with repeat assessments. Blood analyses will include established markers like Aβ42 and p-tau217 plus exploratory markers and genotype. The study includes cognitively unimpaired individuals, MCI patients ( Alzheimer-related and non-Alzheimer-related), and individuals with dementia, with subtyping explored during analysis.

Why it matters

Who can join: the full rules

Inclusion Criteria:

General criteria:

1. Age 50 years or older.
2. Male or female.
3. Able and willing to comply with the study assessments and follow-up procedures.
4. Able to provide written informed consent, or written informed consent is provided by a legally authorized representative when applicable.

Dementia cohort:

1. Diagnosis of dementia established by consensus among three senior neurologists with experience in cognitive disorders.
2. Clinical Dementia Rating score of 1 or higher.
3. 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:

1. Diagnosis of mild cognitive impairment established by consensus among three senior neurologists with experience in cognitive disorders.
2. Clinical Dementia Rating score of 0.5.
3. 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:

1. No history of a major neurological or psychiatric disorder.
2. Clinical Dementia Rating score of 0.

Exclusion Criteria:

1. An acute neurological disorder, including acute stroke, or another medical or neurological condition that would prevent valid assessment of cognitive status.
2. A severe psychiatric disorder that would interfere with cognitive assessment or study participation.
3. Terminal malignant disease or another severe medical condition that would prevent completion of the study procedures.
4. Severe visual or hearing impairment that would interfere with neuropsychological assessment.
5. Inability or unwillingness to complete the planned 12-month follow-up.

Where it's running

• Xuanwu Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Qin Qi, MD, PhD — Xuanwu Hospital, Beijing
• Study coordinator: Qi Qin, MD, PhD
• Email: qinqibao@126.com
• Phone: 8617610103567

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.