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Clinical trial of efficacy and safety of magnetic resonance imaging assisted diagnostic software for Alzheimer's disease

Clinical trial of efficacy and safety of magnetic resonance imaging assisted diagnostic software for Alzheimer's disease

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200055843
Enrollment
Unknown
Registered
2022-01-20
Start date
2022-01-21
Completion date
Unknown
Last updated
2023-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer disease

Interventions

Gold Standard:Senior expert panel review results.
Index test:Software assisted film reading, independent film reading by researchers

Sponsors

Xuanwu Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
55 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged 55 and over, no gender limitation; 2. There were 3D-T1 mri images of the brain; 3. Image layer thickness <= 1.2mm.

Exclusion criteria

Exclusion criteria: 1. There are obvious artifacts that affect the overall image quality in 3D-T1 magnetic resonance imaging, such as motion artifacts, metal artifacts, built-in artifacts, crimp artifacts, flow artifacts, pulsating artifacts, corduroy artifact, etc.; 2. Have a history of intracranial surgery; History of intracranial occupying disease; History of intracranial hemorrhage; History of trauma; History of duct disease and chronic softening foci; History of infectious diseases of the nervous system; History of congenital developmental abnormalities or malformations of the nervous system; Intracranial calcification foci; 3. Vascular dementia, frontotemporal lobe degeneration, Lewy body dementia, cortical basal ganglia degeneration, Parkinson's disease, dementia; 4. The researcher considered that the patients were not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
The sensitivity and specificity of both software-assisted and investigator independent radiographs for the diagnosis of brain structural abnormalities in Alzheimer's disease were determined by the gold standard of radiographs reviewed by a senior expert group;

Secondary

MeasureTime frame
The accuracy of film reading between the experimental group and the control group; False positive rate and false negative rate; negative predictive Value and positive predictive value; Positive likelihood ratio, negative likelihood ratio;Sensitivity and specificity of independent film reading by software;Software performance evaluation;

Countries

China

Contacts

Public ContactLu Jie

Xuanwu Hospital, Capital Medical University

imaginglu@hotmail.com+86 18911507070

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026