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Large-Scale Proteomic Profiling for Identification and Validation of Novel Plasma Biomarkers in Alzheimer's Disease

Large-Scale Proteomic Profiling for Identification and Validation of Novel Plasma Biomarkers in Alzheimer's Disease

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600119963
Enrollment
Unknown
Registered
2026-03-06
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-03-09

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

Conditions

Alzheimer's Disease

Interventions

Healthy Volunteers (Control Group):None
Alzheimer's Disease (AD Group):None

Sponsors

Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Alzheimer's disease (AD group): 1) Age = 60 years; 2) Meets the diagnostic criteria for AD (A+B): A: Specific clinical phenotype: Present with early and significant episodic memory impairment, including the following features: a. The patient or the informant reports memory decline that has persisted for more than 6 months and has progressively worsened; b. Objective evidence of hippocampal type amnestic syndrome, based on AD-specific detection methods, showing a significant decline in episodic memory ability; B: Evidence of AD pathological changes in the body (satisfying any one of the following): a. Decrease in Aß1–42 levels in cerebrospinal fluid and increase in T-tau or P-tau protein levels; b. Increased tracer retention in amyloid PET imaging; c. Presence of autosomal dominant mutations in AD (often carrying mutations in PSEN1, PSEN2, or APP); 3) Clinical Dementia Scale (CDR) = 0.5 points; 4) Agrees to participate and can cooperate with the study, and signs the informed consent form. 2.Mild Cognitive Impairment (MCI Group): 1)Age >= 60 years; 2) Impaired cognitive function, with MMSE score between 24 and 26; 3)Subjective cognitive complaints reported by the individual or an informant; 4)Generally normal activities of daily living, capable of performing daily tasks independently (e.g., ADLs); 5)Mild cognitive impairment confirmed by neuropsychological assessment; 6)Willing to participate, able to comply with the study, and provide written informed consent. 3.Healthy Volunteers (Control Group): 1) Age >= 60 years; 2) Normal cognitive function, with MMSE score >= 27; 3) No subjective complaints or objective symptoms of cognitive impairment; 4) No history of neurological diseases (e.g., stroke, traumatic brain injury, Parkinson's disease); 5) No history of psychiatric disorders (e.g., depression, anxiety), confirmed by professional assessment; 6) No severe systemic diseases (e.g., heart disease, liver disease, kidney disease) that may affect cognitive function; 7) Willing to participate, able to comply with the study, and provide written informed consent.

Exclusion criteria

Exclusion criteria: 1.Alzheimer's disease (AD group): 1) Dementia or cognitive dysfunction caused by other diseases; 2) Complicated with delirium; 3) History of drug abuse; 4) Previous severe traumatic brain injury; 5) Complicated with depression, schizophrenia, Parkinson's disease; 6) Severe hearing loss, aphasia, etc. which affect the scale scores; 7) Complicated with serious diseases such as malignant tumors. 2.Mild Cognitive Impairment (MCI group): 1) Meets the clinical diagnostic criteria for dementia (such as Alzheimer's disease, vascular dementia, etc.); 2) Uses drugs that affect cognitive function (such as antidepressants, antipsychotics, etc.); 3) Has other major physical diseases: such as severe immune disorders, malignant tumors, etc. 3.Healthy volunteers (control group): 1) Have brain organic lesions; 2) Have other major physical diseases: such as severe immune disorders, malignant tumors, etc.

Design outcomes

Primary

MeasureTime frame
Plasma protein markers (differentially expressed proteins: screened by proteomics);

Countries

China

Contacts

Public Contactkai zheng

Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology

diazna2002@sina.com+86 139 7120 1639

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026