Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-30 @ 12:38 AM
Study NCT ID:
NCT07089303
Status:
RECRUITING
Last Update Posted:
2025-08-14
First Post:
2025-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alzheimer's Disease Multinuclear Imaging Neuro-Enhanced Resolution (AD-MINER)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 750}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2029-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-11', 'studyFirstSubmitDate': '2025-07-20', 'studyFirstSubmitQcDate': '2025-07-20', 'lastUpdatePostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'apolipoprotein E (APOE) genotype (ε4 carrier status)', 'timeFrame': 'Baseline', 'description': 'Proportion of participants carrying at least one ε4 allele of the APOE gene.'}, {'measure': 'Identification of genetic susceptibility loci by genome-wide association study (GWAS)', 'timeFrame': 'Baseline', 'description': "Number and genomic location of susceptibility loci associated with Alzheimer's disease, as identified by GWAS."}], 'primaryOutcomes': [{'measure': 'Change from Baseline in Regional Brain Sodium Concentration (mmol/L) Measured by 7 T ²³Na-MRI', 'timeFrame': 'Baseline to 1 year', 'description': 'Quantitative regional brain sodium concentration measured by 7 T sodium (²³Na) MRI; units mmol/L; higher values indicate increased sodium concentration.'}, {'measure': 'Change from Baseline in Resting-State Fractional Amplitude of Low-Frequency Fluctuations（fALFF, unitless) Measured by 7 T fMRI', 'timeFrame': 'baseline to 1year', 'description': 'Fractional Amplitude of fALFF averaged within gray-matter mask (unitless; higher = greater spontaneous activity).'}, {'measure': 'Change from Baseline in Mean Apparent Diffusion Coefficient (ADC) (×10-³ mm²/s) Derived from Dynamic Diffusion-Weighted Imaging (DynDWI)', 'timeFrame': 'Baseline to 1 year', 'description': 'Mean ADC (×10-³ mm²/s) derived from DynDWI; higher values indicate increased diffusivity.'}, {'measure': 'Change From Baseline in Fractional Anisotropy (FA, unitless)', 'timeFrame': 'Baseline to 1 year', 'description': 'Change from baseline in DTI-derived FA values in major white matter tracts; higher FA indicates greater microstructural integrity.'}, {'measure': 'Change From Baseline in Mean Diffusivity (MD, ×10-³ mm²/s)', 'timeFrame': 'Baseline to 1 year', 'description': 'Change from baseline in DTI-derived MD values in major white-matter tracts; higher MD indicates increased water diffusivity (×10-³ mm²/s).'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in Montreal Cognitive Assessment (MoCA) Total Score (0-30, points)', 'timeFrame': 'Baseline to 1 year', 'description': 'Higher scores indicate better global cognition.'}, {'measure': 'Change from Baseline in Clinical Dementia Rating (CDR) Global Score (0-3, points)', 'timeFrame': 'Baseline to 1 year', 'description': 'Higher scores indicate more severe dementia.'}, {'measure': 'Change from Baseline in Mini-Mental State Examination (MMSE) Total Score (0-30, points)', 'timeFrame': 'Baseline to 1 year', 'description': 'Lower scores indicate greater impairment.'}, {'measure': 'Change From Baseline of the Auditory Verbal Learning Test (AVLT) Total Learning Score', 'timeFrame': 'baseline to 1year', 'description': '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.'}, {'measure': 'Change from Baseline in Rey-Osterrieth Complex Figure Test (ROCF) Combined Recall Score (0-72, points)', 'timeFrame': 'baseline to 1year', 'description': '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.'}, {'measure': 'Change From Baseline of the Clock Drawing Test (CDT) Score (0-5, points)', 'timeFrame': 'Baseline to 1 year', 'description': 'CDT score ranges 0-5; higher scores indicate better visuospatial and executive function.'}, {'measure': 'Change From Baseline of the Boston Naming Test (BNT) Total Score (0-60, points)', 'timeFrame': 'Baseline to 1 year', 'description': 'BNT total score ranges 0-60; higher scores indicate better confrontational naming ability.'}, {'measure': 'Change from Baseline in Digit Span Test (DST) Total Score (0-15, points)', 'timeFrame': 'Baseline to 1 year', 'description': 'Forward (0-8) + backward (0-7); higher = better attention/working memory.'}, {'measure': 'Change from Baseline in Symbol Digit Modalities Test (SDMT) Total Score (correct matches per 90 s)', 'timeFrame': 'Baseline to 1 year', 'description': '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.'}, {'measure': 'Change from Baseline in Stroop Color-Word Test (SCWT) Incongruent Condition Completion Time (seconds)', 'timeFrame': 'Baseline to 1 year', 'description': 'Shorter time indicates better cognitive flexibility and inhibition.'}, {'measure': 'Change from Baseline in Neuropsychiatric Inventory (NPI) Total Score (0-144, points)', 'timeFrame': 'Baseline to 1 year', 'description': 'NPI total score ranges 0-144; higher scores indicate more severe neuropsychiatric symptoms.'}, {'measure': 'Change from Baseline in Hamilton Anxiety Rating Scale (HAMA) Total Score (0-56, points)', 'timeFrame': 'Baseline to 1 year', 'description': 'HAMA total score ranges 0-56; higher scores indicate more severe anxiety symptoms.'}, {'measure': 'Change from Baseline in Hamilton Depression Rating Scale (HAMD) Total Score (0-52, points)', 'timeFrame': 'Baseline to 1 year', 'description': 'HAMD total score ranges 0-52; higher scores indicate more severe depressive symptoms.'}, {'measure': 'Change from Baseline in Symptom Checklist-90 (SCL-90) Total Score (90-450, points)', 'timeFrame': 'Baseline to 1 year', 'description': 'SCL-90 total score ranges 90-450; higher scores indicate greater overall psychological distress.'}, {'measure': 'Change from Baseline in Activities of Daily Living (ADL) Scale Score (0-100, points)', 'timeFrame': 'Baseline to 1 year', 'description': 'ADL total score ranges 0-100; higher scores indicate greater independence in basic self-care tasks.'}, {'measure': 'Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score (0-21, points)', 'timeFrame': 'Baseline to 1 year', 'description': 'PSQI total score ranges 0-21; higher scores indicate poorer sleep quality over the past month'}, {'measure': 'Change from Baseline in Trail Making Test (TMT) B-A Difference Score (seconds)', 'timeFrame': 'Baseline to 1 year', 'description': '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.'}, {'measure': 'Plasma Biomarkers of AD', 'timeFrame': 'Baseline to 1 year', 'description': '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.'}, {'measure': 'Change from Baseline in Hippocampal Volume (mm³) by FreeSurfer', 'timeFrame': 'Baseline to 1 year', 'description': 'Bilateral hippocampal volume segmented with FreeSurfer; units mm³.'}, {'measure': 'Number of participants with new cerebral microbleeds detected by susceptibility-weighted imaging (SWI)', 'timeFrame': 'Baseline to 1 year', 'description': 'New microbleeds are defined as the appearance of ≥1 new hypointense lesion on SWI compared to baseline.'}, {'measure': 'Change from Baseline in Brain Perivascular Spaces (PVS) Burden (semi-quantitative score)', 'timeFrame': 'Baseline to 1 year', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alzheimer Disease', 'Mild Cognitive Impairment Due to Alzheimer's Disease']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '55 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 55-90 years (inclusive).\n* 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.\n* Able to undergo MRI scanning (no contraindications to MRI).\n* Group-specific cognitive criteria:\n\nCN: 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.\n\nMCI: 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.\n\nAD: 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).\n\nExclusion Criteria:\n\n* 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.\n* Severe psychiatric disorders (e.g., schizophrenia requiring medication control) or other known brain structural abnormalities.\n* Significant organ failure (heart, liver, kidney, etc.), malignant tumors, or short life expectancy making completion of follow-up unlikely.\n* Contraindications to MRI (e.g., claustrophobia, incompatible pacemaker, aneurysm clip, artificial heart valve, cochlear implant, or other metallic implants).\n* Other clinical history or examination findings judged by investigators as potentially unsafe for MRI or follow-up.\n* Use of investigational drugs within one month prior to enrollment or during the study."}, 'identificationModule': {'nctId': 'NCT07089303', 'acronym': 'AD-MINER', 'briefTitle': "Alzheimer's Disease Multinuclear Imaging Neuro-Enhanced Resolution (AD-MINER)", 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': "Ultra-high Field Multimodal and Multinuclear Neuroimaging Cohort Study of Alzheimer's Disease", 'orgStudyIdInfo': {'id': 'ADMINER-PLAGH-2025'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CN'}, {'label': 'MCI'}, {'label': 'AD'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100853', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yongqin Xiong, MD, PhD', 'role': 'CONTACT', 'email': 'xiongyongqin118@163.com', 'phone': '18285187003'}], 'facility': 'Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director and Clinical Professor', 'investigatorFullName': 'Xin Lou', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}