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This single-center prospective cohort study will enroll 750 participants (250 cognitively Normal (CN) individuals, 250 with mild cognitive impairment (MCI), and 250 with Alzheimer's disease (AD)). At baseline and at annual follow-ups, participants will undergo 3 Tesla (3 T) and 7 Tesla (7 T) multimodal magnetic resonance imaging (MRI) scans, blood biomarker testing, genotyping, and cognitive assessments to identify early imaging biomarkers and construct models of disease progression.
This prospective, single-center cohort will enroll 750 participants (normal controls, MCI, and AD) for at least four years of follow-up. Using ultra-high field 7T multimodal and multinuclear (hydrogen-1 [¹H], sodium-23 [²³Na]) MRI, combined with plasma biomarkers and genetic data, the study aims to identify early neuroimaging biomarkers and clarify the clinical significance of sodium metabolic abnormalities in AD. Structural, functional, and sodium imaging data will be integrated with neuropsychological and blood-based markers, using artificial intelligence for early diagnosis and risk prediction. The study will address technical gaps in early detection and provide the first standardized 7T AD neuroimaging database for the Chinese population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CN | |||
| MCI | |||
| AD |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Regional Brain Sodium Concentration (mmol/L) Measured by 7 T ²³Na-MRI | Quantitative regional brain sodium concentration measured by 7 T sodium (²³Na) MRI; units mmol/L; higher values indicate increased sodium concentration. | Baseline to 1 year |
| Change from Baseline in Resting-State Fractional Amplitude of Low-Frequency Fluctuations（fALFF, unitless) Measured by 7 T fMRI | Fractional Amplitude of fALFF averaged within gray-matter mask (unitless; higher = greater spontaneous activity). | baseline to 1year |
| Change from Baseline in Mean Apparent Diffusion Coefficient (ADC) (×10-³ mm²/s) Derived from Dynamic Diffusion-Weighted Imaging (DynDWI) | Mean ADC (×10-³ mm²/s) derived from DynDWI; higher values indicate increased diffusivity. | Baseline to 1 year |
| Change From Baseline in Fractional Anisotropy (FA, unitless) | Change from baseline in DTI-derived FA values in major white matter tracts; higher FA indicates greater microstructural integrity. | Baseline to 1 year |
| Change From Baseline in Mean Diffusivity (MD, ×10-³ mm²/s) | Change from baseline in DTI-derived MD values in major white-matter tracts; higher MD indicates increased water diffusivity (×10-³ mm²/s). | Baseline to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Montreal Cognitive Assessment (MoCA) Total Score (0-30, points) | Higher scores indicate better global cognition. | Baseline to 1 year |
| Change from Baseline in Clinical Dementia Rating (CDR) Global Score (0-3, points) |
| Measure | Description | Time Frame |
|---|---|---|
| apolipoprotein E (APOE) genotype (ε4 carrier status) | Proportion of participants carrying at least one ε4 allele of the APOE gene. | Baseline |
| Identification of genetic susceptibility loci by genome-wide association study (GWAS) |
Inclusion Criteria:
CN: No subjective memory complaints beyond age expectation (confirmed by study partner); MMSE score 26-30 (inclusive; exceptions permitted for participants with <8 years of education with principal investigator approval; CDR = 0, memory box = 0; Normal cognitive and daily functioning, no significant impairment.
MCI: Subject, partner, or physician reports subjective memory concerns; MMSE criteria same as CN group; CDR = 0.5 (memory box ≥0.5); General cognition and function relatively preserved; does not meet criteria for AD.
AD: Subject, partner, or physician reports subjective memory concerns; MMSE score <26 (inclusive; exceptions as above); CDR = 0.5 or 1.0; Meets National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) probable AD diagnostic criteria or 2024 National Institute on Aging-Alzheimer's Association (NIA-AA) criteria (e.g., positive Pittsburgh compound B (PIB) and tau).
Exclusion Criteria:
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Adults aged 55 to 90 years at the study center, including CN individuals, participants with MCI, and patients diagnosed with AD according to standardized criteria. All participants will undergo comprehensive cognitive assessment, neuroimaging, and biospecimen collection, and will be followed longitudinally for at least four years.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Recruiting | Beijing | Beijing Municipality | 100853 | China |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Higher scores indicate more severe dementia.
| Baseline to 1 year |
| Change from Baseline in Mini-Mental State Examination (MMSE) Total Score (0-30, points) | Lower scores indicate greater impairment. | Baseline to 1 year |
| Change From Baseline of the Auditory Verbal Learning Test (AVLT) Total Learning Score | AVLT total learning score is the sum of Trials N1-N6 (each trial scored 0-15; total range 0-90); higher scores indicate better verbal memory. | baseline to 1year |
| Change from Baseline in Rey-Osterrieth Complex Figure Test (ROCF) Combined Recall Score (0-72, points) | Combined Recall = Immediate Recall (0-36) + Delayed Recall (0-36), scored with the 36-point Osterrieth method; range 0-72. Higher scores indicate better visuospatial (visual) memory. | baseline to 1year |
| Change From Baseline of the Clock Drawing Test (CDT) Score (0-5, points) | CDT score ranges 0-5; higher scores indicate better visuospatial and executive function. | Baseline to 1 year |
| Change From Baseline of the Boston Naming Test (BNT) Total Score (0-60, points) | BNT total score ranges 0-60; higher scores indicate better confrontational naming ability. | Baseline to 1 year |
| Change from Baseline in Digit Span Test (DST) Total Score (0-15, points) | Forward (0-8) + backward (0-7); higher = better attention/working memory. | Baseline to 1 year |
| Change from Baseline in Symbol Digit Modalities Test (SDMT) Total Score (correct matches per 90 s) | SDMT total score is the number of correct symbol-digit matches in 90 seconds (typical range 0-110); higher scores indicate better processing speed and attention. | Baseline to 1 year |
| Change from Baseline in Stroop Color-Word Test (SCWT) Incongruent Condition Completion Time (seconds) | Shorter time indicates better cognitive flexibility and inhibition. | Baseline to 1 year |
| Change from Baseline in Neuropsychiatric Inventory (NPI) Total Score (0-144, points) | NPI total score ranges 0-144; higher scores indicate more severe neuropsychiatric symptoms. | Baseline to 1 year |
| Change from Baseline in Hamilton Anxiety Rating Scale (HAMA) Total Score (0-56, points) | HAMA total score ranges 0-56; higher scores indicate more severe anxiety symptoms. | Baseline to 1 year |
| Change from Baseline in Hamilton Depression Rating Scale (HAMD) Total Score (0-52, points) | HAMD total score ranges 0-52; higher scores indicate more severe depressive symptoms. | Baseline to 1 year |
| Change from Baseline in Symptom Checklist-90 (SCL-90) Total Score (90-450, points) | SCL-90 total score ranges 90-450; higher scores indicate greater overall psychological distress. | Baseline to 1 year |
| Change from Baseline in Activities of Daily Living (ADL) Scale Score (0-100, points) | ADL total score ranges 0-100; higher scores indicate greater independence in basic self-care tasks. | Baseline to 1 year |
| Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score (0-21, points) | PSQI total score ranges 0-21; higher scores indicate poorer sleep quality over the past month | Baseline to 1 year |
| Change from Baseline in Trail Making Test (TMT) B-A Difference Score (seconds) | Difference score calculated as Part B completion time minus Part A completion time (in seconds). Lower scores indicate better executive function after adjusting for processing speed. | Baseline to 1 year |
| Plasma Biomarkers of AD | Percent changes from baseline in: amyloid-beta 40 and 42 (Aβ40, Aβ42), phosphorylated tau 181 and 217 (p-tau181, p-tau217) and neurofilament light (NfL); concentrations in pg/mL. | Baseline to 1 year |
| Change from Baseline in Hippocampal Volume (mm³) by FreeSurfer | Bilateral hippocampal volume segmented with FreeSurfer; units mm³. | Baseline to 1 year |
| Number of participants with new cerebral microbleeds detected by susceptibility-weighted imaging (SWI) | New microbleeds are defined as the appearance of ≥1 new hypointense lesion on SWI compared to baseline. | Baseline to 1 year |
| Change from Baseline in Brain Perivascular Spaces (PVS) Burden (semi-quantitative score) | Description: PVS scored 0-4 in basal ganglia and 0-4 in centrum semiovale on 7 T MRI; global burden is the sum (0-8); higher scores indicate greater PVS load. | Baseline to 1 year |
Number and genomic location of susceptibility loci associated with Alzheimer's disease, as identified by GWAS.
| Baseline |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |