Fuzhou Aging Brain Health Initiative

NCT07891429 | Recruiting DMC

• 1 other identifier: 2026KY695-02
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 4

Brief Summary

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. 1.establishment and follow-up of cohorts in the general population and populations with cognitive impairment;
2. 2.investigation of risk factors and evolutionary patterns of AD pathological characteristics;
3. 3.construction and validation of AD digital phenotypes based on multi-dimensional digital-intelligence screening;
4. 4.exploration of AD-related risk genes and their mechanisms of action;
5. 5.development of novel technologies for plasma biomarkers and PET imaging for the accurate diagnosis of AD.

Conditions

Dementia; Alzheimer Dementia (AD); Mild Cognitive Impairment (MCI); Subjective Cognitive Decline (SCD)

Outcome Measures

Primary Outcomes (10)

• Longitudinal cognitive function _ Clinical Dementia Rating

  Clinical Dementia Rating (CDR). The CDR is used to assess cognitive and functional performance. Scores range from 0 to 3, where 0 indicates no dementia, 0.5 indicates questionable dementia, and higher scores (1, 2, 3) indicate mild, moderate, and severe dementia, respectively. Higher scores indicate a worse outcome.

  through study completion, an average of 1 year

• Longitudinal changes of cognitive function _ Montreal Cognitive Assessment Basic

  Montreal Cognitive Assessment Basic (MoCA-Basic). The MoCA-Basic is a cognitive screening tool with a total score ranging from 0 to 30. Higher scores indicate better cognitive function, while lower scores indicate a worse outcome.

  through study completion, an average of 1 year

• Longitudinal changes of cognitive function _ Mini-mental State Examination, the Chinese version

  Mini-mental State Examination (MMSE, Chinese version). The MMSE is a 30-point questionnaire used to assess cognitive impairment. Scores range from 0 to 30. Higher scores indicate better cognitive function, while lower scores indicate a worse outcome (more severe cognitive impairment).

  through study completion, an average of 1 year

• Longitudinal changes of cognitive function _ Alzheimer's Disease Assessment Scale - Cognitive Subscale

  Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog). The ADAS-Cog is a 70-point scale used to assess cognitive function in Alzheimer's disease. Scores range from 0 to 70. Higher scores indicate a worse outcome (more severe cognitive impairment).

  through study completion, an average of 1 year

• Longitudinal functional and behavioral function _ Neuropsychiatric Inventory

  Neuropsychiatric Inventory (NPI). The NPI is a 144-point scale used to assess neuropsychiatric symptoms in patients with dementia. Scores range from 0 to 144. Higher scores indicate a worse outcome (more severe neuropsychiatric symptoms).

  through study completion, an average of 1 year

• Longitudinal functional and behavioral function _ Geriatric Depression Scale

  Geriatric Depression Scale (GDS-15). The GDS-15 is a 15-item scale used to assess depression in older adults. Scores range from 0 to 15. Higher scores indicate a worse outcome (more severe depressive symptoms).

  through study completion, an average of 1 year

• Longitudinal functional and behavioral function _ Function Activities Questionnaire

  Function Activities Questionnaire (FAQ). The FAQ is a 30-point scale used to assess functional activities in older adults. Scores range from 0 to 30. Higher scores indicate a worse outcome (greater functional impairment/dependency).

  through study completion, an average of 1 year

• Longitudinal functional and behavioral function _Activity of Daily Living Scale

  Activity of Daily Living Scale (ADL). The ADL scale is a 20-item instrument used to assess functional independence in daily living activities, including both basic ADL and instrumental ADL (IADL). Scores range from 20 to 80. Lower scores indicate a better outcome (greater independence), while higher scores indicate a worse outcome (greater dependency).

  through study completion, an average of 1 year

• Longitudinal functional and behavioral function _Pittsburgh Sleep Quality Index

  Pittsburgh Sleep Quality Index (PSQI). The PSQI is a 21-point scale used to assess sleep quality and disturbances over a 1-month interval. Scores range from 0 to 21. Higher scores indicate a worse outcome (poorer sleep quality).

  through study completion, an average of 1 year

• Longitudinal functional and behavioral function _ REM Sleep Behavior Disorder Screening Questionnaire

  REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ). The RBDSQ is a 13-point self-rating questionnaire used to screen for REM sleep behavior disorder. Scores range from 0 to 13, with higher scores indicating a worse outcome (greater likelihood of RBD).

  through study completion, an average of 1 year

Secondary Outcomes (7)

• Longitudinal changes of plasma biomarkers

  through study completion, an average of 1 year

• Longitudinal changes of cerebrospinal fluid biomarkers

  through study completion, an average of 1 year

• Longitudinal changes in neuroimaging _ Magnetic Resonance Imaging

  through study completion, an average of 1 year

• Longitudinal changes in neuroimaging _ Amyloid PET images

  through study completion, an average of 1 year

• Longitudinal changes in neuroimaging _ Tau PET images

  through study completion, an average of 1 year

Other Outcomes (6)

• Correlation of the Evolutionary Patterns of AD Pathological Features

  through study completion, an average of 1 year

• Correlation of AD Risk Genes and Their Mechanisms of Action

  through study completion, an average of 1 year

• Distribution and Carrier Status of AD Genetic Susceptibility Genes and Risk Loci

  Baseline

Study Arms (1)

Alzheimer's disease

Participants meeting NIA-AA 2024 criteria for probable AD dementia. Included for multi-modal data validation and characterization of late-stage disease features.

Diagnostic Test: Fluids biomarker and neuroimaging of AD diagnosis

Interventions

Fluids biomarker and neuroimaging of AD diagnosis DIAGNOSTIC_TEST

Early diagnosis of Alzheimer's disease using fluids biomarker and neuroimaging.

Alzheimer's disease

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. Cognitively Unimpaired (CU): Adults aged 55-90 years with subjective cognitive complaints or without clear cognitive decline, but with risk factors for AD (APOE ε4, family history, subjective memory complaints). Participants undergo digital-intelligent cognitive screening, blood biomarker, and imaging assessments for early detection and risk evaluation. 2. Mild Cognitive Impairment (MCI): Participants meeting MCI diagnostic criteria, with mild memory or other cognitive domain impairment and largely preserved daily function. Enrolled for risk prediction of disease progression and early intervention studies. 3. AD Dementia: Participants meeting NIA-AA 2024 criteria for probable AD dementia. Included for multi-modal data validation and characterization of late-stage disease features.

You may qualify if:

• Age between 55 and 90 years, both sexes eligible;
• Educational level of primary school or above, or with a sound working history, excluding individuals with intellectual disability;
• Able to speak Mandarin fluently and capable of completing the full battery of neuropsychological assessments;
• Geriatric Depression Scale (GDS) score ≤ 6;
• Adequate visual and auditory function to complete all neuropsychological tests successfully;
• Willing and able to provide peripheral blood samples and to undergo brain PET and MRI neuroimaging examinations;
• 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.

You may not qualify if:

• 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;
• Brain MRI findings indicating intracranial infection, cerebral infarction, focal organic lesions, or multiple lacunar infarcts in key memory-related brain regions;
• Contraindications to MRI, such as implanted cardiac pacemakers, or the presence of metallic foreign bodies or fragments within the body;
• 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;
• Past history of schizophrenia, or current pharmacotherapy for obsessive-compulsive disorder or attention deficit disorder;
• History of alcohol or substance abuse or dependence meeting DSM-5 criteria within the past 2 years;
• Concomitant severe systemic diseases or unstable general medical conditions that would preclude participation in the longitudinal follow-up of this study;
• 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);
• Concurrent participation in other neuropsychiatric clinical studies.

Sponsors & Collaborators

• Fujian Medical University Union Hospital: lead

Study Sites (4)

Fuqing City Gaoshan Town Health Center

Fushun, Fujian, 350300, China

RECRUITING

Antai Street Community Health Service Center

Fuzhou, Fujian, 350001, China

RECRUITING

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

Huada Street Community Health Service Center

Fuzhou, Fujian, 350001, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood；Cerebrospinal fluid (CSF)

MeSH Terms

Conditions

Dementia; Alzheimer Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases; Cognition Disorders

Study Officials

• Jiawei Xin

  Fujian Medical University Union Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiawei Xin, MD

CONTACT

86-591-86218026; xinjw@fjmu.edu.cn

Jiawei Xin

CONTACT

86-591-86218026; xinjw@fjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 10, 2026
• First Posted: October 23, 2026
• Study Start: January 1, 2024
• Primary Completion (Estimated): August 31, 2036
• Study Completion (Estimated): August 31, 2036
• Last Updated: October 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)