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

NCT05383053 | Completed DMC

• 1 other identifier: CNUH-2022-108
• Study Type: observational
• Target: 227
• Locations: 1 country
• Sites: 1

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 medical data of patients with mild cognitive impairment to evaluate the effectiveness of artificial intelligence-based brain image detection and diagnosis assistance software 'NeuroAI'.
• Participants; Patient with mild cognitive impairment

Conditions

Alzheimer Disease; Mild Cognitive Impairment

Keywords

Predicting Amyloid PET Positivity

Outcome Measures

Primary Outcomes (2)

• Explore predictive values(Clinical Sensitivity, %)

  Clinical efficacy evaluation of the probability of predicting 'NeuroAI' as positive amyloid PET phase for MR images of positive factors as a result of amyloid PET test

  Jun-2022 until Dec-2022

• Explore predictive values(Clinical Specificity, %)

  Clinical efficacy evaluation of the probability that 'NeuroAI' does not predict positive amyloid PET phase for MR images of negative factors as a result of amyloid PET test

  Jun-2022 until Dec-2022

Secondary Outcomes (2)

• Explore predictive values(AUC of ROC Curve (Area Under the Curve of Receiver Operating Characteristic Curve))

  Jun-2022 until Dec-2022

• Explore predictive values(Accuracy, %)

  Jun-2022 until Dec-2022

Interventions

NeuroAI DEVICE

NeuroAI is an artificial brain diagnostic software that determines whether to perform amyloid PET tests for Alzheimer's by specialists through the detection of amyloid PET positive rates based on brain MR images (T1 weighted MRI, T2 FLAIR MRI) and clinical information (age, gender, and APOE) genotype. When using this product, input gender, birth year, and apolipoproteinE (APOE) genotype and upload T1 MR image and T2 Flair image, input data and image analysis result data are integrated to infer the positive rate of amyloid PET by PET positive prediction model. The result report provides image analysis results and amyloid PET positive prediction results compared to normal groups.

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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 Alzheimer's disease N=227 (10% moderate dropout rate considered; 118 Positive\*, 109 Negative\*\*) \*Positive : Amyloid PET Positive \*\*Negative : Amyloid PET Negative

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neurozen Inc.: lead
• Chonnam National University Hospital: collaborator
• Chosun University Hospital: collaborator

Study Sites (1)

Chonnam National University Hospital

Gwangju, 61469, South Korea

Location

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Byeong Chae Kim, MD

  Professor (Department of Neurology,Chonnam National University Hospital)

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: May 19, 2022
• Study Start: July 22, 2022
• Primary Completion: August 10, 2022
• Study Completion: September 8, 2022
• Last Updated: September 16, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)