💬In plain words
What the trial is, and whether it could suit you
The goal of this observational study is to learn about the pathophysiological characterization and evolutionary patterns of Alzheimer's disease (AD) in older adults in Fujian Province, China. The primary purposes are as follows:
1. establishment and follow-up of cohorts in the general population and populations with cognitive impairment;
2. investigation of risk factors and evolutionary patterns of AD pathological characteristics;
3. construction and validation of AD digital phenotypes based on multi-dimensional digital-intelligence screening;
4. exploration of AD-related risk genes and their mechanisms of action;
5. development of novel technologies for plasma biomarkers and PET imaging for the accurate diagnosis of AD.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
1. Age between 55 and 90 years, both sexes eligible;
2. Educational level of primary school or above, or with a sound working history, excluding individuals with intellectual disability;
3. Able to speak Mandarin fluently and capable of completing the full battery of neuropsychological assessments;
4. Geriatric Depression Scale (GDS) score ≤ 6;
5. Adequate visual and auditory function to complete all neuropsychological tests successfully;
6. Willing and able to provide peripheral blood samples and to undergo brain PET and MRI neuroimaging examinations;
7. If taking relevant medications, the dosage must have been stable for at least 4 weeks. Specific medication requirements: stable doses of antidepressants are permitted, provided that the participant has no significant anticholinergic adverse effects and no history of major depressive episode within the past year; estrogen replacement therapy is allowed; Ginkgo biloba preparations may be taken, but routine use is not recommended; use of any psychoactive drugs is prohibited within 4 weeks prior to screening.
Exclusion Criteria:
1. Coexisting severe neurological disorders, including Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, intracranial tumors, progressive supranuclear palsy, epilepsy, subdural hematoma, multiple sclerosis, etc.; history of severe traumatic brain injury with persistent neurological deficits, or history of definite structural brain abnormalities;
2. Brain MRI findings indicating intracranial infection, cerebral infarction, focal organic lesions, or multiple lacunar infarcts in key memory-related brain regions;
3. Contraindications to MRI, such as implanted cardiac pacemakers, or the presence of metallic foreign bodies or fragments within the body;
4. Diagnosis of major depressive disorder or bipolar disorder according to DSM-5 criteria within the past 1 year; presence of psychotic symptoms, agitation, or aggressive behavior within the past 3 months that would preclude compliance with the study protocol;
5. Past history of schizophrenia, or current pharmacotherapy for obsessive-compulsive disorder or attention deficit disorder;
6. History of alcohol or substance abuse or dependence meeting DSM-5 criteria within the past 2 years;
7. Concomitant severe systemic diseases or unstable general medical conditions that would preclude participation in the longitudinal follow-up of this study;
8. Clinically significant abnormalities in serum vitamin B12 or thyroid function indicators, with direct exclusion for those presenting with decreased vitamin B12 levels;
9. Current use of psychoactive drugs, including antidepressants, neuroleptics, long-acting anxiolytics, or sedative-hypnotics; long-term use of anticoagulants such as warfarin, dabigatran, rivaroxaban, or apixaban (except for lumbar puncture procedures);
10. Concurrent participation in other neuropsychiatric clinical studies.
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