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Construction of a community cohort for healthy aging and dementia in northern China and early prediction of AD

Construction of a community cohort for healthy aging and dementia in northern China and early prediction of AD

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300070598
Enrollment
Unknown
Registered
2023-04-18
Start date
2023-05-01
Completion date
Unknown
Last updated
2023-06-04

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

Conditions

Alzheimer's disease

Interventions

Sponsors

Foshan Nanhai District People's Hospital (The Sixth Hospital Affiliated to South China University of Technology)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
55 Years to 90 Years

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

MeasureTime frame
Diagnosis of cognitive impairment;Overall cognitive change;

Secondary

MeasureTime frame
Neuropsychological subdomain changes;Changes in body fluid biomarkers;Atrophic changes in brain regions in structural magnetic resonance;

Countries

China

Contacts

Public ContactCangzheng Jin

Foshan Nanhai District People's Hospital (The Sixth Hospital Affiliated to South China University of Technology)

378639506@qq.com+86 13798691369

Outcome results

None listed

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