DementiaFAITHNCT07891429
Fuzhou Aging Brain Health Initiative
An observational study of Dementia and Alzheimer Dementia (AD), run by Fujian Medical University Union Hospital at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Dementia, Alzheimer Dementia (AD), Mild Cognitive Impairment (MCI)
- What is being tested?
- Fluids biomarker and neuroimaging of AD diagnosis
- How many people
- 3,000 participants
- Where
- 4 sitesChina
- Study dates
- 1 Jan 2024to 31 Aug 2036
- How long will I take part?
- 10 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 10Show fewer
- Concomitant severe systemic diseases or unstable general medical conditions that would preclude participation in the longitudinal follow-up of this study;
- Clinically significant abnormalities in serum vitamin B12 or thyroid function indicators, with direct exclusion for those presenting with decreased vitamin B12 levels;
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Fuqing City Gaoshan Town Health Center
Fushun, Fujian, 350300
Yusi Zhang, 86-591-86218026, neurozys@163.com
- Recruiting
Antai Street Community Health Service Center
Fuzhou, Fujian, 350001
Xilin Wu, 86-591-86218026, xilin_163@163.com
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Jiawei Xin, MD, 86-591-86218026, xinjw@fjmu.edu.cn
- Recruiting
Huada Street Community Health Service Center
Fuzhou, Fujian, 350001
Wenting Fang, 86-591-86218026, drwenting@163.com
About this study
Official title: Fuzhou Aging Brain Health Initiative--Health Aging and Alzheimer's Disease Cohort and Early Diagnosis and Treatment Research
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:
- establishment and follow-up of cohorts in the general population and populations with cognitive impairment;
- investigation of risk factors and evolutionary patterns of AD pathological characteristics;
- construction and validation of AD digital phenotypes based on multi-dimensional digital-intelligence screening;
- exploration of AD-related risk genes and their mechanisms of action;
- development of novel technologies for plasma biomarkers and PET imaging for the accurate diagnosis of AD.
Read the detailed description
Alzheimer's disease (AD) represents a major public health challenge in China's aging society, and early screening and intervention are key to reducing the incidence of AD dementia. This project, in collaboration with multiple community health service centers in Fujian Province, China, aims to establish a retrospective and prospective, multi-center AD cohort. We plan to enroll approximately 3,000 elderly volunteers and collect comprehensive baseline and longitudinal follow-up data, including multi-dimensional digital-intelligence screening, plasma/cerebrospinal fluid biomarkers (Aβ42/Aβ40, p-Tau217, NfL, GFAP, sTREM2, etc.), APOE genotyping, electroencephalographic features, multi-modal MRI, and Aβ/tau PET imaging.
All participants will undergo cognitive assessment, genetic screening, and blood sample collection. Some participants will also undergo cerebrospinal fluid (CSF) collection, electroencephalography (EEG), digital cognitive testing, MRI scans, Aβ PET scans, and tau PET scans. Annual follow-up will be conducted for all participants.
- Conditions
- Dementia, Alzheimer Dementia (AD), Mild Cognitive Impairment (MCI), Subjective Cognitive Decline (SCD)
- Being tested
- Fluids biomarker and neuroimaging of AD diagnosis
- Medical subject headings
- Dementia, Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluids biomarker and neuroimaging of AD diagnosisDiagnostic test
Early diagnosis of Alzheimer's disease using fluids biomarker and neuroimaging.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Fluids biomarker and neuroimaging of AD diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: through study completion, an average of 1 year
Secondary outcomes (7)
Longitudinal changes of plasma biomarkers
Longitudinal changes of disease status as categorized by plasma biomarkers of Alzheimer's diseases over time.
Measured: through study completion, an average of 1 year
Longitudinal changes of cerebrospinal fluid biomarkers
Longitudinal changes of disease status as categorized by cerebrospinal fluid (CSF) biomarkers of Alzheimer's diseases over time.
Measured: through study completion, an average of 1 year
Longitudinal changes in neuroimaging _ Magnetic Resonance Imaging
Longitudinal change in brain structure using magnetic resonance imaging (MRI)
Measured: through study completion, an average of 1 year
Longitudinal changes in neuroimaging _ Amyloid PET images
Longitudinal changes in amyloid deposition
Measured: through study completion, an average of 1 year
Longitudinal changes in neuroimaging _ Tau PET images
Longitudinal changes in tau deposition
Measured: through study completion, an average of 1 year
Longitudinal changes in Electroencephalogram Features
Longitudinal Changes in AD-Related Electroencephalogram (EEG) Features
Measured: through study completion, an average of 1 year
Longitudinal changes in digital cognitive phenotype
Based on multimodal data including eye tracking (fixation duration, saccadic velocity, pupillary response), behavioral responses (reaction time, accuracy, task completion patterns), and spatial navigation (path efficiency, spatial memory error), construct a digital cognitive phenotype of AD and investigate the longitudinal changes in the digital cognitive phenotype.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start1 Jan 2024
- Primary completion31 Aug 2036 (estimated)
- Study completion31 Aug 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiawei Xin, Fujian Medical University Union Hospital
- Investigators
- Jiawei Xin, Principal investigator, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07891429
- Sponsor's protocol ID
- 2026KY695-02
- Acronym
- FAITH
- Status last verified
- Sep 2026
- First submitted
- 10 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No