Mild cognitive impairment (MCI), Alzheimer’s disease (AD), vascular dementia (VaD), dementia with Lewy bodies (DLB), and frontotemporal dementia (FTD)
Conditions
Interventions
Gold Standard:This study used internationally accepted diagnostic criteria. Alzheimer’s disease (AD) was diagnosed using the 2018 NIA-AA framework, combining clinical symptoms and biomarker evidence.
Index test:(1) zero-field magnetic imaging (ZMI)
(2) multimodal MRI—including structural MRI, DTI, ASL, and rs-fMRI
(3) an AI fusion model combining MRI and ZMI data
(4) an MRI-only AI model
(5) a ZMI-only AI model
(6) MRI- and/or ZMI-derived biomarkers
and (7) a conventional machine learning baseline.
Sponsors
Hangzhou First People's Hospital
Eligibility
Sex/Gender
All
Age
50 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1.Individuals aged 50 to 85 years, inclusive, irrespective of sex. 2.A minimum of six years of formal education (equivalent to completion of primary school or higher) is required to ensure sufficient literacy and cognitive capacity for effective participation in neuropsychological assessments. 3.Native language: Chinese; proficient in reading, writing, and oral communication in English. 4.All participants, or their legally authorized representatives, have been provided with comprehensive information regarding the study objectives, procedures, potential risks and benefits, and have voluntarily consented to participation by signing a written informed consent document. 5.Reliable collateral informants—such as spouses or adult children—are available to provide objective and longitudinal information regarding changes in the subjects’ daily functioning and behavioral patterns.
Exclusion criteria
Exclusion criteria: 1.History of major neurological disorders: A documented history of neurological conditions—other than those under investigation in this study—that are associated with cognitive impairment, including but not limited to brain tumors; Parkinson’s disease (PD) without concomitant Lewy body dementia (LBD) or Parkinson’s disease dementia (PDD); multiple sclerosis; Huntington’s disease; normal pressure hydrocephalus; central nervous system infections (e.g., neurosyphilis, HIV-associated neurocognitive disorder); and autoimmune or inflammatory neurological disorders. Additionally, a confirmed diagnosis of epilepsy or a history of severe traumatic brain injury accompanied by persistent, objectively documented neurological deficits is exclusionary. 2.History of Severe Mental Illness: A documented diagnosis—current or past—of a severe mental disorder, including but not limited to schizophrenia or bipolar I disorder. At the time of assessment, the individual is experiencing a current major depressive episode, as confirmed by a Hamilton Depression Rating Scale (HDRS-17) score exceeding 24 points. Furthermore, clinical evaluation has established that the observed cognitive impairment is primarily attributable to the depressive episode, consistent with the phenomenological construct of “depressive pseudodementia.”; 3.Systemic diseases and metabolic disorders: Untreated severe hypothyroidism; profound deficiencies of vitamin B12 or folate; decompensated severe hepatic or renal failure; and uncontrolled severe endocrine disorders. 4.History of substance use disorder: The patient has a documented diagnosis of alcohol or substance use disorder within the past 12 months. 5.Exclusion Criterion: Prolonged administration of pharmacological agents with established adverse effects on cognitive function—such as high-dose anticholinergic medications and benzodiazepines—when discontinuation prior to cognitive assessment is clinically contraindicated or otherwise not feasible. 6.Sensory and physical impairments: Severe, uncorrectable hearing or visual impairments that preclude valid administration of neuropsychological assessments. Severe motor or physical disabilities that impede the individual’s ability to comply with procedural requirements for MRI or ZMI examinations. 7.Contraindications for magnetic resonance imaging (MRI) include: (1) the presence of ferromagnetic or electronically active implanted devices—such as cardiac pacemakers, implantable cardioverter-defibrillators (ICDs), neurostimulators, and intracranial aneurysm clips—that pose safety risks or compromise image quality; (2) severe claustrophobia precluding tolerance of prolonged immobilization within the scanner bore; and (3) other metallic or electronic foreign bodies that may cause significant artifacts or interfere with radiofrequency signal acquisition. 8.Other exclusion criteria include: (1) diagnosis of a malignant neoplasm or another severe systemic illness associated with an anticipated life expectancy of less than three years; and (2) concurrent enrollment in another interventional clinical trial evaluating a similar intervention.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The diagnostic accuracy of artificial intelligence–based multimodal fusion models; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sensitivity and specificity;Area Under the Receiver Operating Characteristic Curve (AUC);F1 score;Abnormal key biomarkers (imaging/electrophysiology/body fluid, feces, etc.); | — |
Countries
China
Contacts
Public ContactHe Xiao
Hangzhou First People's Hospital
Outcome results
None listed