TRACE4AD

DeepTrace Technologies Srl

TRACE4AD provides the subject's level of risk (low or high risk) of having or progressing to Alzheimer's disease dementia within 24 months, by an automatic reading of the subject's brain gray matter obtained from a 3D structural T1-weighted MRI brain study, also in combination with subject’s neuropsychological measures.

Information source: Vendor
Last updated: April 19, 2022

General Information

General
Product name	TRACE4AD
Company	DeepTrace Technologies Srl
Subspeciality	Neuro
Modality	MR
Disease targeted	Alzheimer’s disease dementia
Key-features	Mild cognitive impairment (MCI) subject risk score (low risk vs high risk) of being affected by or progressing to Alzheimer's disease dementia within 24 months, cognitive, functional and behavioral deficits of the subject, subject gray matter volume and images with normative comparison, best voxel-based map predictors overlayed on the subject gray matter, best neuropsychological predictors
Suggested use	During: interactive decision support (shows abnormalities/results only on demand), report suggestion After: diagnosis verification

Technical Specifications

Data characteristics
Population	Amnestic Mild Cognitive Impairment (MCI) subjects on the recommendation of neurology specialists
Input	T1-weighted, MP-RAGE, 3D MRI; brain, cognitive, functional and behavioral measures
Input format	DICOM, Nifti, nrrd, pdf
Output	High vs low risk of being affected by or progressing to AD dementia within 2 years, cognitive functional and behavioral deficits, gray matter volume and images, voxel-based map predictors overlayed on gray matter, best neuropsychological predictors
Output format	PDF
Technology
Integration	Stand-alone third party application, Stand-alone webbased
Deployment	Locally on dedicated hardware, Cloud-based
Trigger for analysis	On demand, triggered by a user through e.g. a button click, image upload, etc.
Processing time	> 10 minutes

Regulatory

Certification
CE	Certified, Class I , MDD
FDA	No or not yet
Intended Use Statements
Intended use (according to CE)	TRACE4AD is indicated for subjects at risk of Alzheimer's disease dementia on the recommendation of neurology specialists. Radiology specialists with neuroradiological expertise can use TRACE4D to support the reporting of brain MRI investigations in these subjects. Neurology specialists can use TRACE4AD as an aid to diagnosis and prognosis. TRACE4AD software provides the subject level of risk (low risk or high risk) of being affected by or progressing to Alzheimer's disease dementia within 24 months of the date of the TRACE4AD processed examination, i.e., the subject's brain MRI investigation, possibly in combination with a neuropsychological examination performed no earlier than and no later than one month from the brain MRI. However, it should be noted that DeepTrace Technologies S.R.L. considers TRACE4AD as a support to the neurologists in their diagnosis and prognosis, and as a support to the radiology specialists with neuroradiological expertise in their reporting of brain MRI investigations, who have the sole decision making responsibility.

Market

Market presence
On market since	05-2021
Distribution channels
Countries present (clinical, non-research use)
Paying clinical customers (institutes)
Research/test users (institutes)
Pricing
Pricing model	Subscription
Based on	Number of users, Number of installations, Number of analyses

Evidence

Evidence
Peer reviewed papers on performance	TRACE4AD v2.0: MRI characterizes the progressive course of AD and predicts conversion to Alzheimer’s dementia 24 months before probable diagnosis (read)
Non-peer reviewed papers on performance
Other relevant papers