Exploratory Clinical Study and Validation of Blood Biomarkers for Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Quantification of Blood Biomarkers in Alzheimer's Disease and Healthy Subjects
研究概览
简要总结
This is a 24-month, monocentric, exploratory and observational clinical study aimed at developing and validating a blood-based diagnostic test for Alzheimer's disease (AD). The test is based on two complementary biomarkers: conformational changes in Protein Kinase C (PKC) and aggregation of β-amyloid peptide on red blood cell membranes. The study will also establish a biobank of serum, plasma, urine, and RNA samples for future biomarker research.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For All Participants (HV and AD groups):
- •Age between 50 and 85 years
- •Ability to understand and sign informed consent
- •Availability for the full duration of the study (24 months)
- •Fasting capability for morning sample collection (between 8:30-12:00)
- •Willingness to provide blood and urine samples for biomarker analysis and biobank storage
- •Additional Criteria for Healthy Volunteers (HV):
- •No history or current diagnosis of neurodegenerative disease
- •Normal cognitive function confirmed by neuropsychological testing (e.g., MMSE score within normal range)
- •No significant abnormalities on brain imaging (CT or MRI if performed)
- •No use of medications affecting cognitive function
- •Additional Criteria for Alzheimer's Disease Patients (AD):
- •Clinical diagnosis of probable Alzheimer's disease based on standardized criteria
- •Cognitive impairment confirmed by neuropsychological testing (e.g., MMSE score below threshold)
- •Supporting evidence from brain imaging (CT or MRI) and/or cerebrospinal fluid biomarkers (if available)
- •Stable medical condition allowing participation in study procedures
排除标准
- •For All Participants:
- •History of major psychiatric disorders (e.g., schizophrenia, bipolar disorder)
- •Significant neurological conditions other than Alzheimer's disease (e.g., Parkinson's disease, stroke)
- •Active malignancy or history of cancer within the past 5 years (except localized skin cancer)
- •Severe renal, hepatic, or cardiovascular disease
- •Current participation in another interventional clinical trial
- •Known blood disorders or conditions affecting red blood cell morphology or function
- •Recent blood transfusion (within 3 months)
- •Substance abuse or alcohol dependence
- •Inability to comply with study procedures
- •Additional Exclusion for Healthy Volunteers:
- •Any cognitive complaints or subjective memory loss
- •First-degree family history of Alzheimer's disease (optional, depending on stratification strategy)
- •Use of psychoactive medications
- •Additional Exclusion for Alzheimer's Disease Patients:
- •Diagnosis of mixed or atypical dementia
- •Rapidly progressive cognitive decline suggestive of other pathology
- •Contraindications to lumbar puncture (if CSF sampling is planned)
结局指标
主要结局
Quantification of Blood Biomarkers in Alzheimer's Disease and Healthy Subjects
时间窗: At baseline (Visit 0)
Measurement and comparison of two blood-based biomarkers-(1) conformational change in Protein Kinase C (PKC) and (2) aggregation of β-amyloid peptide (Aβ1-42) on red blood cell membranes-between patients diagnosed with Alzheimer's disease and age- and sex-matched healthy volunteers. The goal is to assess the diagnostic performance of each biomarker individually.
次要结局
- Analytical Performance of Biomarkers Across Demographic and Clinical Variables(Within 1 month after sample collection)
- Establishment of a Biobank for Future Biomarker Research(Throughout the 24-month study period)