Ultra-high Field Multimodal and Multinuclear Neuroimaging Cohort Study of Alzheimer's Disease

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Maximum Age: 90
Healthy Volunteers: t
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• 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).

Locations
Other Locations
China
Chinese PLA General Hospital
RECRUITING
Beijing
Time Frame
Start Date: 2025-07-01
Estimated Completion Date: 2029-08
Participants
Target number of participants: 750
Treatments
CN
MCI
AD
Related Therapeutic Areas
Sponsors
Leads: Chinese PLA General Hospital

This content was sourced from clinicaltrials.gov