Clinical Trials in China / NCT07891429
Recruiting
Observational
Fuzhou Aging Brain Health Initiative
NCT07891429 · tracked via the Priya Life Science China tracker
Condition(s) studied
DementiaAlzheimer Dementia (AD)Mild Cognitive Impairment (MCI)Subjective Cognitive Decline (SCD)
Investigational drug(s) / intervention(s)
Fluids biomarker and neuroimaging of AD diagnosis
Fluids biomarker and neuroimaging of AD diagnosis: Early diagnosis of Alzheimer's disease using fluids biomarker and neuroimaging.
Study 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. 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.
Eligibility
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.
Primary outcome measure(s)
- Longitudinal cognitive function _ Clinical Dementia Rating — through study completion, an average of 1 year
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. - Longitudinal changes of cognitive function _ Montreal Cognitive Assessment Basic — through study completion, an average of 1 year
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. - Longitudinal changes of cognitive function _ Mini-mental State Examination, the Chinese version — through study completion, an average of 1 year
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). - Longitudinal changes of cognitive function _ Alzheimer's Disease Assessment Scale - Cognitive Subscale — through study completion, an average of 1 year
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). - Longitudinal functional and behavioral function _ Neuropsychiatric Inventory — through study completion, an average of 1 year
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). - Longitudinal functional and behavioral function _ Geriatric Depression Scale — through study completion, an average of 1 year
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). - Longitudinal functional and behavioral function _ Function Activities Questionnaire — through study completion, an average of 1 year
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). - Longitudinal functional and behavioral function _Activity of Daily Living Scale — through study completion, an average of 1 year
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). - Longitudinal functional and behavioral function _Pittsburgh Sleep Quality Index — through study completion, an average of 1 year
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). - Longitudinal functional and behavioral function _ REM Sleep Behavior Disorder Screening Questionnaire — through study completion, an average of 1 year
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).
Trial sites (4)
| Facility | City | Region | Status |
|---|---|---|---|
| Fuqing City Gaoshan Town Health Center | Fushun | Fujian | Recruiting |
| Antai Street Community Health Service Center | Fuzhou | Fujian | Recruiting |
| Fujian Medical University Union Hospital | Fuzhou | Fujian | Recruiting |
| Huada Street Community Health Service Center | Fuzhou | Fujian | Recruiting |
More Fujian Medical University Union Hospital trials in China
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07891429 on ClinicalTrials.gov ↗ ← All trials in China