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临床试验/ITMCTR1900002341
ITMCTR1900002341尚未招募1 期

Clinical study for diagnostic markers in cerebrospinal fluid of Alzheimer's disease

The Third Affiliated Hospital of Zhejiang Chinese Medical University0 个研究点开始时间: 待定最近更新:
适应症

试验速览

阶段
1 期
状态
尚未招募
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Diagnostic test

入排标准

性别
All

入选标准

  • 1. Aged>=60 years old;
  • 2. Meet the diagnostic criteria of clinical typical AD;
  • 3. Specific clinical phenotype, early and significant episodic memory impairment (isolated or other cognitive, behavioral changes associated with implicated dementia syndrome or mild cognitive impairment), including the following characteristics:
  • (1) The patient or the insider complains that the memory ability has gradually declined over 6 months;
  • (2) The objective evidence of the hippocampus type amnesia syndrome, based on the AD-specific detection method--through the clue recall test, found that the episodic memory ability decreased significantly, according to the simple intelligent mental state checklist MMSE diagnostic criteria: illiterate group = 17 points, primary school group = 20 points, middle school or above group = 24 points (heavy disease in moderate stage dementia stage hippocampus amnesia syndrome may be difficult to identify, in vivo AD pathological evidence is sufficient to exist in the characteristics of dementia syndrome: cerebrospinal fluid Aß42 reduction, bilateral frontal apical area glucose radioactivity Counting drops significantly).

排除标准

  • 1. Severe hemodynamic instability and unstable vital signs;
  • 2. Malignant arrhythmia, severe failure of organ function such as heart, lung, liver and kidney, suffering from tumor;
  • 3. Cognitive impairment cannot be matched with lumbar puncture;
  • 4. Participated in other clinical studies within 2 months prior to the start of the study;
  • 5. The patient or his licensor is unwilling to sign a written informed consent or is unwilling to follow the research protocol;
  • 6. Other types of dementia:
  • (1) sudden onset;
  • (2) Early symptoms: gait disorder, epilepsy, behavioral changes.
  • Clinical features:
  • (1) focal neurological features;
  • (2) early extrapyramidal signs;
  • (3) early hallucinations;
  • (4) cognitive fluctuations.
  • Additional tests: such as blood tests, head MR diagnosed with other diseases (or associated disorders) that cause cognitive disorders or dementia, including other serious diseases that are sufficient for memory and related symptoms: (1) non-AD dementia;
  • (2) major depression;
  • (3) Cerebrovascular disease;
  • (4) Poisoning, inflammation, metabolic disorders (including diabetes, etc.), which require a specific examination e. Consistent with infection or vascular injury, medial temporal lobe MRI-FLAIR or T2 signal changes.

研究者

发起方
The Third Affiliated Hospital of Zhejiang Chinese Medical University

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