amyotrophic lateral sclerosis
Conditions
Interventions
Sponsors
Hangzhou First People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Participants must meet all of the following criteria; 1.Age >=18; 2.Stable medication dosage permitted within 4 weeks prior to screening; 3.GDS score = 18 years, with BMI within a reasonable range; 5.Subject or legal guardian signs written informed consent and is able to cooperate with all sample collections and examinations; Inclusion Criteria for Healthy Control Group; 1.Age, sex, and BMI should be matched as closely as possible to the ALS group; 2.Good health status, with no history of major acute or chronic diseases; 3.No history, symptoms, or signs of neurological disease; 4.No family history of ALS or other neurological diseases; 5.Sign the informed consent form; 6.MMSE score 24–30; 7.CDR = 0, with a memory item score of 0; Inclusion Criteria for AD Group; 1.Meet the diagnostic criteria of the National Institute on Aging and Alzheimer's Association (NIA-AA); 2.Subject or legal guardian signs written informed consent, agreeing to complete clinical assessments, imaging examinations, biosample collection, and study follow-up; 3.Inclusion Criteria for PD Group; 4.Meet the diagnostic criteria of the International Movement Disorder Society (MDS) for Parkinson's disease; 5.Subject or legal guardian signs written informed consent, agreeing to complete clinical assessments, imaging examinations, biosample collection, and study follow-up;
Exclusion criteria
Exclusion criteria: 1.Exclusion Criteria for ALS Group; 2.Exclude cervical spondylotic myelopathy, multifocal motor neuropathy, syringomyelia, Kennedy disease, progressive spinal muscular atrophy, primary lateral sclerosis, and other similar conditions; 3.Concurrent severe diseases of vital organs (heart, liver, kidney, etc.), malignant tumors, autoimmune diseases, active infections, or severe psychiatric disorders; 4.Use of medications that may affect omics testing within the past 1 month, especially antibiotics, immunosuppressants, hormones, or receipt of stem cell/gene therapy, participation in other interventional studies, etc. 5.For microbiome analysis subjects, exclude those who have used antibiotics or regularly consumed probiotic products within the past 1 month; 6.History of major trauma, surgery, or severe illness within the past 3 months; 7.History of complex gastrointestinal surgery, PEG, severe gastrointestinal diseases, or special travel history that may affect sample stability; 8.Other conditions that the investigator deems unsuitable for enrollment; 9.Exclusion Criteria for Healthy Control Group; 10.History of infection, medication use, or vaccination within the past 1 month, especially antibiotics, immunosuppressants, or hormones; 11.Clinically significant abnormalities in laboratory tests; 12.Severe heart, liver, or kidney diseases, malignant tumors, autoimmune diseases, active infections, psychiatric disorders, etc. 13.Long-term smoking, alcohol abuse, or history of drug abuse, etc. 14.Pregnancy or lactation; 15.High-risk travel history within the past 6 months; 16.History of complex gastrointestinal surgery or PEG, etc; 17.Exclusion Principles for AD/PD Groups; 18.Exclude other reversible causes of cognitive impairment, severe systemic diseases, inability to comply with follow-up, and those affected by prohibited recent medication use as listed in the protocol. 19.For the PD group, special attention should be given to excluding dementia with Lewy bodies, Alzheimer's disease, vascular dementia, and interference from anticholinergic drugs, anti-Parkinson medications, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Electroencephalogram outcome;Biomarker outcome;Imaging outcome;Clinical outcome;Clinical outcome; | — |
Secondary
| Measure | Time frame |
|---|---|
| Biomarker outcome;Cognitive outcome;Lifestyle outcome;Clinical outcome;Cognitive outcome; | — |
Countries
China
Contacts
Public ContactHao Zhang
Hangzhou First People's Hospital
Outcome results
None listed