Predicting biomarkers that signal when mild cognitive impairment will progress to dementia.

Studies on Biomarkers for Mild Cognitive Impairment Conversion to Dementia

This project will try to find blood, imaging, and brain electrical markers in people aged 50–85 with mild cognitive impairment to see who will progress to dementia over five years.

Quick facts

• Study type: Observational
• Enrollment: 900 (estimated)
• Ages: 50 Years to 85 Years
• Sex: All
• Sponsor: Xuanwu Hospital, Beijing (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT05697588 on ClinicalTrials.gov

What this trial studies

This is a 5-year prospective cohort enrolling 900 people with mild cognitive impairment and collecting extensive baseline and annual data. Baseline measures include demographics, clinical and neuropsychological testing (MMSE, MoCA, CDR), multi-modal neuroimaging (structural and functional MRI, DTI, FDG-PET, amyloid‑ and tau‑PET), neuroelectrophysiology (resting EEG, evoked potentials, polysomnography), and biofluids (blood, cerebrospinal fluid, urine, saliva) analyzed with methods like ELISA and SIMOA. Participants will be followed yearly and classified as MCI progression (MCI-P) or MCI stabilization (MCI-S) based on neuropsychological outcomes. Differences across clinical, imaging, electrophysiologic, and multi-omics fluid markers will be compared to identify combinations that predict conversion to dementia.

Who should consider this trial

Good fit: Adults aged 50–85 with mild cognitive impairment (MMSE 15–28, CDR ≤1) who can give informed consent and complete testing are the intended participants.

Not a fit: People whose cognitive problems are explained by other neurological or systemic diseases, who have contraindications to MRI, or who cannot complete testing or consent are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this work could identify people at high risk earlier so clinicians can target interventions to delay or prevent dementia.

How similar studies have performed: Previous smaller studies using single biomarkers (for example imaging or fluid markers) have shown promise, but multi-modal prediction models like this have not yet been widely validated in clinical practice.

Eligibility criteria

Inclusion Criteria:

* Male or female patients aged ≥50 and ≤85 years;

  * Meet the diagnostic criteria for dementia or MCI; ③ Neuropsychological score: MMSE 15-28 points, CDR≤1 point; ④ The patients and their families were informed and signed the informed consent.

Exclusion Criteria:

* There are other neurological diseases that can cause brain dysfunction (such as depression, brain tumors, Parkinson's disease disease, metabolic encephalopathy, encephalitis, multiple sclerosis, epilepsy, traumatic brain injury, normal intracranial pressure hydrocephalus, etc.);

  * There are other systemic diseases that can cause cognitive impairment (such as hepatic insufficiency, renal insufficiency, Thyroid dysfunction, severe anemia, folic acid or vitamin B12 deficiency, syphilis, HIV infection, alcohol and drug abuse, etc.);

    * Suffering from a disease that cannot cooperate with the completion of cognitive examination; ④ There are contraindications to nuclear magnetic resonance;

      * There is mental and neurodevelopmental delay; ⑥ refuse to draw blood; ⑦ Refuse to sign the informed consent.

Where this trial is running

Beijing, Beijing Municipality

• Xuan Wu Hospital of Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Cuibai Wei — Xuan Wu Hospital of Capital Medical University
• Study coordinator: Cuibai Wei

Conditions Biomarkers; MCI Conversion to Dementia