Alzheimer DiseaseAD-MINERNCT07089303
Alzheimer's Disease Multinuclear Imaging Neuro-Enhanced Resolution (AD-MINER)
An observational study of Alzheimer Disease and Mild Cognitive Impairment Due to Alzheimer's Disease, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
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)). Read more about this study
- Who is it for?
- Ages 55 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Mild Cognitive Impairment Due to Alzheimer's Disease
- How many people
- 750 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to Aug 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: 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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Yongqin Xiong, MD, PhD, 18285187003, xiongyongqin118@163.com
About this study
Official title: Ultra-high Field Multimodal and Multinuclear Neuroimaging Cohort Study of Alzheimer's Disease
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.
Read the 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.
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CN | Not described | |
| MCI | Not described | |
| AD | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline to 1 year
Secondary outcomes (21)
Change from Baseline in Montreal Cognitive Assessment (MoCA) Total Score (0-30, points)
Higher scores indicate better global cognition.
Measured: Baseline to 1 year
Change from Baseline in Clinical Dementia Rating (CDR) Global Score (0-3, points)
Higher scores indicate more severe dementia.
Measured: Baseline to 1 year
Change from Baseline in Mini-Mental State Examination (MMSE) Total Score (0-30, points)
Lower scores indicate greater impairment.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Baseline to 1 year
Change from Baseline in Hippocampal Volume (mm³) by FreeSurfer
Bilateral hippocampal volume segmented with FreeSurfer; units mm³.
Measured: 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.
Measured: 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.
Measured: Baseline to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start1 Jul 2025
- Primary completionJul 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- 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
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xin Lou, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07089303
- Sponsor's protocol ID
- ADMINER-PLAGH-2025
- Acronym
- AD-MINER
- Status last verified
- Jul 2025
- First submitted
- 20 Jul 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra-high Field Multimodal and Multinuclear Neuroimaging Cohort Study of Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT07089303
- Acronym / sponsor ID
- AD-MINER / ADMINER-PLAGH-2025
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 28 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CN | – | – |
| MCI | – | – |
| AD | – | – |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from Baseline in Regional Brain Sodium Concentration (mmol/L) Measured by 7 T ²³Na-MRI
Time frame: Baseline to 1 year
Quantitative regional brain sodium concentration measured by 7 T sodium (²³Na) MRI; units mmol/L; higher values indicate increased sodium concentration.
Change from Baseline in Resting-State Fractional Amplitude of Low-Frequency Fluctuations（fALFF, unitless) Measured by 7 T fMRI
Time frame: baseline to 1year
Fractional Amplitude of fALFF averaged within gray-matter mask (unitless; higher = greater spontaneous activity).
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
Mean ADC (×10-³ mm²/s) derived from DynDWI; higher values indicate increased diffusivity.
Change From Baseline in Fractional Anisotropy (FA, unitless)
Time frame: Baseline to 1 year
Change from baseline in DTI-derived FA values in major white matter tracts; higher FA indicates greater microstructural integrity.
Change From Baseline in Mean Diffusivity (MD, ×10-³ mm²/s)
Time frame: Baseline to 1 year
Change from baseline in DTI-derived MD values in major white-matter tracts; higher MD indicates increased water diffusivity (×10-³ mm²/s).
21 secondary outcomes
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
Change from Baseline in Hamilton Depression Rating Scale (HAMD) Total Score (0-52, points)
Time frame: Baseline to 1 year
Change from Baseline in Symptom Checklist-90 (SCL-90) Total Score (90-450, points)
Time frame: Baseline to 1 year
Change from Baseline in Activities of Daily Living (ADL) Scale Score (0-100, points)
Time frame: Baseline to 1 year
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score (0-21, points)
Time frame: Baseline to 1 year
Change from Baseline in Trail Making Test (TMT) B-A Difference Score (seconds)
Time frame: Baseline to 1 year
Plasma Biomarkers of AD
Time frame: Baseline to 1 year
Change from Baseline in Hippocampal Volume (mm³) by FreeSurfer
Time frame: Baseline to 1 year
Number of participants with new cerebral microbleeds detected by susceptibility-weighted imaging (SWI)
Time frame: Baseline to 1 year
Change from Baseline in Brain Perivascular Spaces (PVS) Burden (semi-quantitative score)
Time frame: Baseline to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Mild Cognitive Impairment Due to Alzheimer's Disease, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Regional Brain Sodium Concentration (mmol/L) Measured by 7 T ²³Na-MRI (time frame: Baseline to 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.