Aging Brain Health Initiative in Fujian

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project establishes retrospective and prospective cohorts of older adults, including those with cognitive impairment, to study the progression and pathophysiology of Alzheimer's disease. It gathers comprehensive baseline and annual follow-up data using digital cognitive tools, blood and CSF biomarkers, APOE genotyping, EEG, MRI, and PET imaging for Aβ and tau. The study aims to develop digital phenotypes and validate biomarkers and imaging techniques to improve early diagnosis. Participants undergo cognitive assessments, genetic screening, blood draws, and, where feasible, CSF collection and multimodal imaging. About 3,000 volunteers across multiple Fujian sites will be followed over time to track disease evolution.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fuqing City Gaoshan Town Health Center
  Fushun, Fujian, China Recruiting
• Antai Street Community Health Service Center
  Fuzhou, Fujian, China Recruiting
• Fujian Medical University Union Hospital
  Fuzhou, Fujian, China Recruiting
• Huada Street Community Health Service Center
  Fuzhou, Fujian, China Recruiting

Study contacts

• Principal investigator: Jiawei Xin — Fujian Medical University Union Hospital
• Study coordinator: Jiawei Xin, MD
• Email: xinjw@fjmu.edu.cn
• Phone: 86-591-86218026

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.