Alzheimer's Disease Multinuclear Imaging Neuro-Enhanced Resolution (AD-MINER)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Alzheimer Disease, Mild Cognitive Impairment Due to Alzheimer's Disease. Basic parameters: 55 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Ultra-high Field Multimodal and Multinuclear Neuroimaging Cohort Study of Alzheimer's Disease
Overview
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.
Detailed description
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.
Primary outcome measures
- Change from Baseline in Regional Brain Sodium Concentration (mmol/L) Measured by 7 T ²³Na-MRI [Time frame: Baseline to 1 year]
- Change from Baseline in Resting-State Fractional Amplitude of Low-Frequency Fluctuations（fALFF, unitless) Measured by 7 T fMRI [Time frame: baseline to 1year]
- Change from Baseline in Mean Apparent Diffusion Coefficient (ADC) (×10-³ mm²/s) Derived from Dynamic Diffusion-Weighted Imaging (DynDWI) [Time frame: Baseline to 1 year]
- Change From Baseline in Fractional Anisotropy (FA, unitless) [Time frame: Baseline to 1 year]
- Change From Baseline in Mean Diffusivity (MD, ×10-³ mm²/s) [Time frame: Baseline to 1 year]
Secondary outcome measures (12)
- Change from Baseline in Montreal Cognitive Assessment (MoCA) Total Score (0-30, points) [Time frame: Baseline to 1 year]
- Change from Baseline in Clinical Dementia Rating (CDR) Global Score (0-3, points) [Time frame: Baseline to 1 year]
- Change from Baseline in Mini-Mental State Examination (MMSE) Total Score (0-30, points) [Time frame: Baseline to 1 year]
- Change From Baseline of the Auditory Verbal Learning Test (AVLT) Total Learning Score [Time frame: baseline to 1year]
- Change from Baseline in Rey-Osterrieth Complex Figure Test (ROCF) Combined Recall Score (0-72, points) [Time frame: baseline to 1year]
- Change From Baseline of the Clock Drawing Test (CDT) Score (0-5, points) [Time frame: Baseline to 1 year]
- Change From Baseline of the Boston Naming Test (BNT) Total Score (0-60, points) [Time frame: Baseline to 1 year]
- Change from Baseline in Digit Span Test (DST) Total Score (0-15, points) [Time frame: Baseline to 1 year]
- Change from Baseline in Symbol Digit Modalities Test (SDMT) Total Score (correct matches per 90 s) [Time frame: Baseline to 1 year]
- Change from Baseline in Stroop Color-Word Test (SCWT) Incongruent Condition Completion Time (seconds) [Time frame: Baseline to 1 year]
- Change from Baseline in Neuropsychiatric Inventory (NPI) Total Score (0-144, points) [Time frame: Baseline to 1 year]
- Change from Baseline in Hamilton Anxiety Rating Scale (HAMA) Total Score (0-56, points) [Time frame: Baseline to 1 year]
Eligibility criteria
Inclusion criteria
- Age 55-90 years (inclusive).
- Willing and able to participate in baseline assessment and longitudinal follow-up; voluntary provision of biospecimens and personal information, and commitment to complete all follow-up visits.
- Able to undergo MRI scanning (no contraindications to MRI).
- Group-specific cognitive 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
- Self-reported or MRI-detected major neurological diseases other than AD: including but not limited to stroke (cerebral hemorrhage, infarction), congenital intellectual disability, intracranial tumors, epilepsy, Parkinson's disease, Huntington's disease, normal pressure hydrocephalus, progressive supranuclear palsy, multiple sclerosis, severe head trauma with persistent deficits, etc.
- Severe psychiatric disorders (e.g., schizophrenia requiring medication control) or other known brain structural abnormalities.
- Significant organ failure (heart, liver, kidney, etc.), malignant tumors, or short life expectancy making completion of follow-up unlikely.
- Contraindications to MRI (e.g., claustrophobia, incompatible pacemaker, aneurysm clip, artificial heart valve, cochlear implant, or other metallic implants).
- Other clinical history or examination findings judged by investigators as potentially unsafe for MRI or follow-up.
- Use of investigational drugs within one month prior to enrollment or during the study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Chinese PLA General Hospital — Beijing
Identifiers
NCT: NCT07089303 · ADMINER-PLAGH-2025