Status:
COMPLETED
Evaluating the Efficacy of Artificial Intelligence-based Computer Aided Diagnosis Software That Assists in Determining Whether or Not to Conduct Amyloid PET for the Diagnosis of Alzheimer's Disease by Predicting Amyloid PET Positivity in Mild Cognitive Impairment Patients
Lead Sponsor:
Neurozen Inc.
Collaborating Sponsors:
Chonnam National University Hospital
Chosun University Hospital
Conditions:
Alzheimer Disease
Mild Cognitive Impairment
Eligibility:
All Genders
50+ years
Brief Summary
* Purpose of clinical trial; This clinical trial is designed to evaluate the effectiveness of 'NeuroAI' prediction accuracy compared to the amyloid PET test results by retrospectively collecting medic...
Detailed Description
* Clinical recruitment; Brain MR images (T1 weighted MRI+T2 FLAIR MRI) of patients who underwent clinical diagnosis for mild cognitive impairment and performed amyloid PET tests for suspected Alzheime...
Eligibility Criteria
Inclusion
- Brain MR images of image providers suitable for all of the following selection criteria may be registered in this clinical trial.
- Among those diagnosed with mild cognitive impairment (MCI) in accordance with the International Working Group on Mild Cognitive Impairment criteria, those aged 50 or older on the MRI scan date.
- Those who have undergone 3D configurable 3T MRI (brain T1 weighted MRI\* and T2 FLAIR MRI\*\*) tests.
- \* 40-slice 2D T1 MRI scan: Plane shall be photographed with sagittal hippocampus.
- \*\* 3-slice 2D T2-FLAIR MRI scan: Plane shall be taken by axial.
- FBB (F-18 Florbetaben) amyloid PET test for suspected Alzheimer's mild cognitive impairment is positive or negative.
- ☞ Images diagnosed with clear cerebral matrix damage (e.g., brain tumor, cerebral infarction, brain damage, normal pressure hydrocephalus, encephalitis) or mild cognitive impairment caused by metabolic diseases cannot participate in this clinical trial.
- A person who has the following clinical information recorded.
- Date of birth (or full age), gender, APOE genotype, mild cognitive impairment diagnosis date, mild cognitive impairment causative disease (Alzheimers, vascular, Louise, Parkinson's disease, frontal lobe, cerebral tumor, cerebral infarction, normal pressure head disease, encephalitis, unknown, other), MRI scan day, amyloid PET test\*, FBB PET-BAPL score\*\* \*\*However, for FBB PET BAPL score, you may participate in this clinical trial even if the information is not recorded.
Exclusion
- Brain MR images of image providers that fall under any of the following exclusion criteria cannot be registered in this clinical trial.
- MR images already used as training sets or validation sets for developing medical devices for clinical trials.
- ☞Chonnam National University Hospital and Chosun University Hospital use images not included in GARD cohort.
- If the interval between the date of diagnosis of mild cognitive impairment and the date of MRI scan/amyloid PET examination exceeds 2 years.
- If the tester determines that participation in the clinical trial is inappropriate because it may affect other, ethical or clinical trial results.
- Specific reasons shall be stated in the case record.
Key Trial Info
Start Date :
July 22 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 8 2022
Estimated Enrollment :
227 Patients enrolled
Trial Details
Trial ID
NCT05383053
Start Date
July 22 2022
End Date
September 8 2022
Last Update
September 16 2022
Active Locations (1)
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1
Chonnam National University Hospital
Gwangju, South Korea, 61469