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Evaluation of Therapeutic Efficacy in Alzheimer's Disease: Analysis via Single-Molecule Immunoassay Biomarkers

Research on the exploration of early fluid biomarkers for neurodegenerative diseases based on multi-omics technology

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500107899
Enrollment
Unknown
Registered
2025-08-20
Start date
2024-06-03
Completion date
Unknown
Last updated
2025-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Interventions

Group of chronic neurodegenerative diseases:NA
Group of Acute Neurodegenerative Diseases:NA

Sponsors

Zhengzhou Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 90 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for neurodegenerative diseases: 1. Age 50 to 90 years old, no gender restrictions; 2. Patients with neurodegenerative diseases that meet clinical diagnostic criteria; 3. Subsequent MRI results are required to assist in differential diagnosis; 4. Participants must fully understand the inclusion requirements and sign the informed consent. Inclusion criteria for healthy controls: 1. Age 50 to 90 years old, no gender restrictions; 2. Normal healthy individuals undergoing physical examinations; 3. Normal blood routine, blood biochemistry, urine routine, and infection indicators; 4. Participants must fully understand the inclusion requirements and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Participants under 50 years old or over 90 years old are excluded. 2. Participants who have undergone surgery, trauma or pregnancy within the past six months are excluded. 3. Participants with a history of stereotactic surgery on the head (including neuroablative procedures or deep brain stimulation) are excluded. 4. Participants with obvious mental disorders or severe cardiovascular comorbidities are excluded. 5. Participants whose peripheral blood samples show signs of coagulation or have been stored for too long after collection are excluded.

Design outcomes

Primary

MeasureTime frame
Amyloid-beta 42;Amyloid-beta 40;Phosphorylated tau at threonine 181;Total tau protein;Neurofilament Light Chain;Glial Fibrillary Acidic Protein;

Secondary

MeasureTime frame
mini-mental state examination,,MMSE;activities of daily life ,ADL;neuropsychiatric inventory, NPI;Clinical Dementia Rating Scale - Total Score,CDR-SB;Clinical Doctor Interview Supplementary Scale for Impression of Disease Changes,CIBIC-plus;

Countries

China

Contacts

Public ContactShoukui Hu

Zhengzhou Central Hospital

shoukuihu@163.com+86 138 1105 9772

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026