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Application study of urine AD7c-NTP in the early diagnosis of elderly patients with Alzheimer's disease

Application study of urine AD7c-NTP in the early diagnosis of elderly patients with Alzheimer's disease

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100047657
Enrollment
Unknown
Registered
2021-06-21
Start date
2021-06-21
Completion date
Unknown
Last updated
2022-02-28

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

Conditions

elderly patients with Alzheimer's disease

Interventions

Gold Standard:neuropsychological scale
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Sponsors

Drum Tower Hospital of Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
60 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Elderly aged 60-85; 2. Well cooperated to complete the neuropsychological scale test, urine test, blood test; 3. Sign informed consent; 4. The subjects will be divided into NC group, SCD group and MCI group for the first time according to the score of neuropsychological scale. (1) Diagnostic criteria of SCD: 1) Compared with the previous normal state, self-perceived persistent cognitive decline which is not related to acute events; 2) All the standard cognitive tests adjusted for age, sex and education level were normal; 3) In addition, SCD that may be preclinical for AD also has the following characteristics : subjective memory but not other cognitive domains decline; within 5 years of onset; age of onset >=60 years old; SCD-related concerns (or concerns); feeling worse than the same age group; the diagnosis is more likely to be confirmed by people with knowledge, ApoE e4 genotype and other biomarkers of AD; (2) MCI diagnostic criteria: 1) The chief complaint of subjective memory decline has been confirmed by their family members or escorts; 2) There was MCI evidence after objective Examination. 3) Clinical Dementia Rating (CDR) of one or more neighborhoods >=0.5 points; Total CDR 24 points.

Exclusion criteria

Exclusion criteria: 1. Clinical stroke or history of stroke: Head MRI showed lesions with a diameter of > 2cm (if there was imaging evidence of subcortical, periventricular and deep cerebral infarction, except those with five symptoms and corresponding history); 2. The Hachinski Ischemia Index Scale> 4; 3. Cognitive impairment caused by intracranial space-occupying lesions, central nervous system infection, craniocerebral injury, epilepsy, multiple sclerosis, toxic metabolic disease, Parkinson's disease, intracranial tumor, hypothyroidism, etc; 4. Depression or anxiety, schizophrenia; Have a history of alcohol or drug dependence; Taking cognitive-improving medications; 5. Complicated with serious heart, liver and kidney dysfunction and urinary system diseases.

Design outcomes

Primary

MeasureTime frame
SEN, SPE, ACC, AUC of ROC;SEN, SPE, ACC, AUC of ROC;

Countries

China

Contacts

Public ContactLi Shanshan

Nanjing Drum Tower Hospital

shshli133@163.com+86 15161471468

Outcome results

None listed

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