Establish Diagnostic and Prognostic Models for Preclinical AD Patients Based on Multimodal MRI, Behavioral, Genetic, and Plasma Biomarkers

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-79
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

About this trial

To establish the diagnostic and prognostic models that could help the preclinical identification of subjects at higher risk of clinical progression to mild cognitive impairment and dementia based on combined features of baseline demographic, cognitive, behavioral, multimodal MRI, genetic, and plasma data.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

The inclusion criteria were 50-79 years old and having 8 or more years of education.

Disqualifiers

Participants with a history of stroke, other neurological disorders that could lead to cognitive impairment (Parkinson's disease, encephalitis, epilepsy, brain tumors, etc.), severe anxiety or depression, and contraindications for magnetic resonance imaging (MRI) were not enrolled.

Trial population

Chinese Han nationality

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Multimodal magnetic resonance imaging scanning, behavioral, genetic and plasma biomarker testing

    Other intervention

    Multimodal magnetic resonance imaging scanning, including 3DT1, 3DT2, 3DFLAIR, functional MRI, DTI, NODDI, ASL, QSM behavioral testing, such as olfaction and spatial navigation genetic testing, such as APOE, BDNF plasma biomarker testing, such as ptau, Aβ42/40、NfL、GFAP

Treatment groups

1,000 Participants
are divided into 4 treatment groups
Group A: Normal control1 intervention
Group B: Subjective cognitive decline1 intervention
Group C: Mild cognitive impairment1 intervention
Group D: Alzheimer's disease dementia1 intervention

Trial outcomes

Primary outcomes

1

the area under the curve of the classification analysis between progressors and nonprogressors

We'll measure the area under the curve of the ROC curves based on combined features of baseline demographic, cognitive, behavioral, multimodal MRI, genetic, and plasma data in discriminating those convert to MCI or AD (progressors) from those do not convert (nonprogressors)

Time frame
Baseline, Year 1, Year 2, Year 3

Secondary outcomes

1

mediation effects of MRI on the associations between gene/plasma biomarker and cognition/behavior

We'll explore whether MRI features could act as mediators between genetic factors and cognition or behavior, as well as between plasma biomarkers and cognition or behavior.

Time frame
Baseline

Other outcomes

Sponsors and contacts

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