CompletedNot Applicable

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

South Korea227 participantsStarted 2022-07-22

Plain-language 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

Who can participate

Age range50 Years

SexALL

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Inclusion criteria

✓. 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.
✓. FBB (F-18 Florbetaben) amyloid PET test for suspected Alzheimer's mild cognitive impairment is positive or negative.
✓. A person who has the following clinical information recorded.

Exclusion criteria

✕. MR images already used as training sets or validation sets for developing medical devices for clinical trials.
✕. 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.

What they're measuring

Explore predictive values(Clinical Sensitivity, %)

Timeframe: Jun-2022 until Dec-2022

Explore predictive values(Clinical Specificity, %)

Timeframe: Jun-2022 until Dec-2022

Trial details

NCT IDNCT05383053

SponsorNeurozen Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-08-10

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