Alzheimer's disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 5.1 Basic Enrollment Criteria. [1] Ability to sign written informed consent; subject and/or, in the case of reduced decision-making capacity, a legal representative in compliance with state law who can read, understand, and provide written informed consent. [2] Peripatetic age = 55 years at baseline enrollment. [3] Willingness and ability to complete all requirements of the study (e.g., peripheral organ function assessment, EEG, lumbar puncture, MRI and PET imaging, etc.) [4] able to complete the assessment alone or with the assistance of an accompanying person [5] The subject has good vision and hearing and is able to perform neuropsychological testing (glasses and hearing aids may be worn) [6] BMI 3 months [3] Normal overall cognitive function, MMSE score 24-30 [4] Clinical measures confirm mild cognitive impairment. aMCI scores for episodic memory impairment such as delayed story recall (DSR) are at least 1.5 SD lower than the average for age-matched populations, with other cognitive domains remaining relatively intact. Non-amnesic mono-regional MCI (snmMCI) had impairments in executive functioning such as clock drawing test (CDT) scores that were more than 1.0 SD below the age-matched population average. Multi-regional (mdMCI) had impairments in at least 2 cognitive areas that were each 1.0 SD below the age-matched population mean, and their severity did not meet dementia criteria. [5] Clinical Dementia Rating Scale (CDR) = 0.5 points, with a score of at least 0.5 points on the memory item of the amnestic CDR scale. [6] The ability to perform normal activities of daily living remains intact. [7] Exclusion of other causes of dementia or any physical and mental disorders that can cause brain dysfunction.
Exclusion criteria
Exclusion criteria: [1] Those who refuse information collection such as questionnaires or refuse to provide biological samples such as blood, urine, saliva, dental plaque, etc. for conducting [2] have had or are currently having a stroke with clinical symptoms within the past 12 months, or have had an acute event within the past 6 months that the investigator judges to be a transient ischemic attack [3] previous or current intracranial masses that may impair cognition (e.g., glioma, meningioma) [4] Previous or existing systemic autoimmune disease that may cause progressive neurological disease leading to cognitive deficits (e.g., multiple sclerosis, lupus erythematosus, antiphospholipid antibody syndrome, and Beh?et's disease); concomitant other dementia-causing conditions (e.g., vitamin B12 deficiency, hypothyroidism, neurosyphilis, acquired immunodeficiency syndrome, Parkinson's disease dementia, vascular dementia, frontal temporal lobe dementia, multiple sclerosis, depression, and traumatic brain injury). [5] Have a psychiatric disorder such as schizophrenia, affective disorder, etc. [6] Those with claustrophobia. [7] Patients with severe heart, brain, liver, and kidney hematopoietic disorders or other serious primary diseases [8] Severe malnutrition, drug or alcohol abuse. [9] Patients with lumbosacral deformities of the spine that may become contraindicated for lumbar puncture, etc. [10] Patients with human immunodeficiency virus infection. [11] Those who cannot tolerate MRI or have contraindications to MRI, including but not limited to: pacemaker implants that are incompatible with MRI; aneurysm clips, artificial heart valves, ear implants, or foreign metal implants in the eye, skin, or body that prohibit MRI scanning; or other clinical history or findings that, in the judgment of the investigator, may lead to potential harm on MRI. [12] Use of antibiotics, probiotics, prebiotics or synbiotics within 6 months prior to stool collection. [13] Treatment for periodontitis or oral surgery within 3 months prior to screening. [14] untreated caries, periapical lesions or oral abscesses. [15] frequent oral ulcers, oral mucosal diseases such as lichen planus and Candida infection, periodontal diseases such as gingivitis, periodontitis, chronic dry mouth, and oral odor. [16] use of mouthwash or oral treatment within 1 week prior to oral sampling; acute oral diseases such as acute pulpitis, acute periodontal abscess, acute pericoronitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnosis of cognitive impairment;Overall cognitive change; | — |
Secondary
| Measure | Time frame |
|---|---|
| Neuropsychological subdomain changes;Changes in body fluid biomarkers;Atrophic changes in brain regions in structural magnetic resonance; | — |
Countries
China
Contacts
Foshan Nanhai District People's Hospital (The Sixth Hospital Affiliated to South China University of Technology)