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

Phase 1

• Conditions: Alzheimer's disease

• Registration Number: ITMCTR1900002341
• Lead Sponsor: The Third Affiliated Hospital of Zhejiang Chinese Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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).

Exclusion Criteria

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:
History:
(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.

Study & Design

• Study Type: Diagnostic test
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SEN, SPE, ACC, AUC of ROC;Succinylation marker;