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

NCT06561906 | Recruiting

• 1 other identifier: 2023-341-01
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alzheimer Disease, Late Onset; Mild Cognitive Impairment; Subjective Cognitive Decline

Keywords

magnetic resonance imaging; spatial navigation; olfaction; genetic; plasma biomarkers

Outcome Measures

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)

  Baseline, Year 1, Year 2, Year 3

Secondary Outcomes (1)

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

  Baseline

Study Arms (4)

Normal control

Subjects without memory complaints and associated worries and do not meet the diagnostic criteria for mild cognitive impairment (MCI) are recruited as normal control (NC).

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

Subjective cognitive decline

Subjects who complain of memory decline within the last 5 years and express worries associated with memory decline and do not meet the diagnostic criteria for MCI are defined as subjective cognitive decline (SCD).

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

Mild cognitive impairment

Participants are considered MCI patients with scores \>1 standard deviation (SD) below the normative means in both subtests within one cognitive domain or \>1 SD below the normative means in three single tests in three different domains.

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

Alzheimer's disease dementia

Patients are diagnosed as AD dementia by an experienced neurologist based on MMSE and CSF/PET biomarker evidence.

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

Interventions

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

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

Alzheimer's disease dementia; Mild cognitive impairment; Normal control; Subjective cognitive decline

Eligibility Criteria

• Age: 50 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chinese Han nationality

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

RECRUITING

Related Publications (1)

• Chen Q, Chen F, Long C, Zhu Y, Jiang Y, Zhu Z, Lu J, Zhang X, Nedelska Z, Hort J, Zhang B. Spatial navigation is associated with subcortical alterations and progression risk in subjective cognitive decline. Alzheimers Res Ther. 2023 Apr 25;15(1):86. doi: 10.1186/s13195-023-01233-6.

  PMID: 37098612 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction; Spatial Navigation; Anosmia

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Spatial Behavior; Behavior; Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: August 20, 2024
• Study Start: September 1, 2020
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 20, 2024

Record last verified: 2024-06

Locations

CN (1)