Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05383053 |
| Other study ID # |
CNUH-2022-108 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 22, 2022 |
| Est. completion date |
September 8, 2022 |
Study information
| Verified date |
September 2022 |
| Source |
Neurozen Inc. |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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
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 Alzheimer's disease.
- Target number of images; Total 227 (median dropout rate considered 10%; Positive*118,
Negative**109)
*Positive: Amyloid PET Positive
**Negative: Amyloid PET Negative
- Selection criteria; Brain MR images of image providers suitable for all of the following
selection criteria may be registered in this clinical trial.
1. 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.
2. 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.
3. 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.
4. 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 criteria; Brain MR images of image providers that fall under any of the
following exclusion criteria cannot be registered in this clinical trial.
1. 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.
2. If the interval between the date of diagnosis of mild cognitive impairment and
the date of MRI scan/amyloid PET examination exceeds 2 years.
3. 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.
- Clinical trial method;
1. Medical data of patients with mild cognitive impairment (brain MR images (T1
weighted MRI+T2 FLAIR MRI) and clinical information**) are continuously collected
at Chosun University Hospital and Chonnam National University Hospital. However,
the data used for NeuroAI learning is not collected.
☞ When moving medical data at Chosun University Hospital, an external hard drive
with permission set so that only the tester can access it is used and delivered
directly to the tester without using mail or other means.
*Anonymization: permanently deleting personal identification information or
replacing all or part of the personal identification information with the unique
identification symbol of the organization.
**Clinical information: Date of birth (or full age), gender, education level, APOE
genotype, mild cognitive impairment diagnostic date, mild cognitive impairment
causative disease (Alzheimers, vascular, Louise, Parkinson's disease, frontal lobe,
brain tumor, cerebral infarction, normal hydrocephalus, unknown, other test days
(PET).
2. The collected medical data is stored in the NAS server built in the data center of
Chonnam National University Hospital, a clinical trial institution. In this case,
access rights should be set so that third parties other than the tester cannot
access medical data.
3. When medical data collection is completed, the tester checks whether the
selection/exclusion criteria are met. Only brain MR images of image providers that
meet all selection/exclusion criteria are enrolled in this clinical trial.
4. When all images are registered, the tester releases the envelope containing the
random array table and gives each image a random array number according to the
random array table. The release of envelopes should be implemented immediately
prior to the delivery of images to clinical trial medical care managers.
- A random arrangement table is generated by a statistician in charge of a
random arrangement, sealed in an envelope, and delivered to the tester.
- The tester who released the envelope shall manage the random arrangement table
not to be disclosed to others during the clinical trial period.
5. The tester shall deliver to the clinical trial medical care manager a document
containing MR images with random arrangement numbers and clinical information
(birth year, gender, APOE genotype, MRI date) required for application of clinical
trial medical devices.
☞ The images and documents delivered to the clinical trial medical care manager are
blindfolded so that they do not include any information other than random
arrangement numbers and clinical information entered into the clinical trial
medical device.
6. The clinical trial medical device manager checks the amyloid PET positive
prediction information using the clinical trial medical device. After completing
the confirmation of predictive information on the last image, the clinical trial
medical manager extracts and collects the predictive information of all registered
images in the form of a database, and delivers it to the data manager.
☞ During the clinical trial period, other test personnel other than medical care
managers set access to the data so that predictive information of medical devices
for clinical trials cannot be viewed.
7. For all images, the clinical trial ends when the clinical information and
predictive information of the medical device for clinical trial are collected.
- Clinical efficacy evaluation variable;
- First Clinical efficacy Assessment; Clinical Sensitivity(%), Clinical
Specificity(%)
- Secondary Clinical efficacy Assessment; AUC of ROC Curve (Area Under the Curve of
Receiver Operating Characteristic Curve), Accuracy(%)
