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Risk screening and early diagnosis in patients with Alzheimer's disease

Risk screening and early diagnosis in patients with Alzheimer's disease

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100044626
Enrollment
Unknown
Registered
2021-03-24
Start date
2021-04-01
Completion date
Unknown
Last updated
2021-10-26

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

Conditions

Alzheimer's disease

Interventions

Gold Standard:(1) Clinical diagnosis of AD was made according to the diagnostic criteria of AD proposed by NIA-AA (2011 edition)
(2) The diagnosis of AD can be made according to the 2011 edition of NIA-AA or 2014 edition of IWG-2 diagnostic criteria when molecular imaging examination and cerebrospinal fluid detection
Index test:neurofilament&#32
protein(NfL),&#32

Sponsors

The First Affiliated Hospital, Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 100 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for AD group: 1. Aged >= 60 years old, = 60 years old, <= 100 years old; 2. Can speak mandarin (or dialect to effectively communicate with doctors); 3. I or my family members sign the informed consent; 4. Can cooperate to complete the selected scale; 5. Health as defined by the absence of clinically relevant abnormalities: based on a detailed history, physical examination (including blood pressure, heart rate measurements, and clinical laboratory tests); 6. Complete PET and indicate negative amyloid protein.

Exclusion criteria

Exclusion criteria: Exclusion criteria for AD group: 1. Hearing impairment, visual impairment, poor coordination; 2. A lifetime history of schizophrenia, schizoaffective disorder or bipolar disorder; 3. Subjects currently taking antidepressants; 4. Past electroconvulsive therapy; 5. A history of alcohol abuse or dependence after two years of screening; 6. Long-term history of heavy alcohol consumption (alcohol degree greater than 42 degrees, more than 3 2 / day, drinking more than 12 months); 7. A history of uncontrolled malignant tumors within one year (including tumors of the nervous system and tumors outside the nervous system); 8. Any serious systemic disease or unstable condition that makes it difficult to comply with the protocol, including: A history of serious pulmonary disease (COPD, pulmonary encephalopathy); A history of serious cardiovascular disease (heart failure, severe hypertension); 9. Participants who are not suitable for MRI include, but are not limited to, use of a pacemaker, metal plates near the eye or near the spinal cord, and cochlear implantation. (Dental filling materials have no risk of MRI use); 10. Subjects with the following clinically significant symptoms or history: history of severe nervous system infection of any cause, history of multiple sclerosis, history of immune encephalitis, history of Hashimoto's encephalopathy, etc.; Epileptic seizures that are not currently under stable control due to a variety of previous causes; A history of hereditary diseases that may affect cognitive function (e.g. Huntington's disease, Down's syndrome, Cadasil syndrome, adrenoencephalodystrophy, mitochondrial encephalopathy, etc.); Infections and immune-related diseases affecting the central nervous system (systemic lupus erythematosus, undertreated HIV infection or a history of CNS spiralling infection, etc.); Metabolic diseases and endocrine disorders that affect the central nervous system (thyroid dysfunction, folic acid or vitamin B12 deficiency requiring new treatment or modification of current treatment); Epileptic seizures that are not currently under stable control due to a variety of previous causes; 11. A history of clinically significant and unstable gastrointestinal diseases, including ulcers, severe or occult gastrointestinal bleeding, in the past two years; 12. Exclusion criteria related to systemic diseases affecting nervous system function and abnormal liver and kidney function (abdominal dialysis or hemodialysis during the screening period; AST or ALT >= 3 x upper limit of normal value (ULN) or total bilirubin >= 2 x ULN in screening stage; 13. Uncontrolled diabetes; 14. The history of unstable malignancy (including tumors of the nervous system and tumors outside the nervous system) was reviewed within one year; 15. Non-compliance or inability to perform PET tests, or negative for PET amyloid protein; 16. Drugs excluded from the study included: 1) use of narcotic drugs, methyldopa, and clonidine during the 4 weeks prior to screening; 2) Use of anti-Parkinson's drugs (such as sinemide, amantadine, bromocriptine, pergolide and celecirin) within 2 months prior to screening; 3) In the 4 weeks before screening, short-term anti-anxiety drugs or sedative hypnotics should be used more than twice a week (Note: sedative drugs should not be used within 72 hours after screening); 4) Systemic corticosteroid use within 3 months prior to screening; 5) Use of anticonvulsants (such as phenytoin, phe

Design outcomes

Primary

MeasureTime frame
neurofilament light chain protein;Exosome;Consistency;

Countries

China

Contacts

Public ContactPei Zhong

The First Affiliated Hospital, Sun Yat-Sen University

peizhong@mail.sysu.edu.cn+86 13725391010

Outcome results

None listed

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