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:
Chinese PLA General Hospital
Organization:
Study Overview
Official Title:
Ultra-high Field Multimodal and Multinuclear Neuroimaging Cohort Study of Alzheimer's Disease
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AD-MINER
Brief 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)). 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: