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BrainSee is a software application indicated as a prognostic tool to aid in the clinical assessment of how likely patients aged between 55 and 95 years old who are diagnosed with amnestic mild cognitive impairment (aMCI) are to progress to clinical Alzheimer's disease (AD)-dementia within 5 years of assessment. BrainSee analyzes inputs of brain magnetic resonance imaging (MRI), patient demographic information, and cognitive assessment scores to produce a similarity score between 0 and 100 reflecting the degree of similarity between the patient and two reference populations of aMCI patients who either did not progress to clinical AD-dementia within 5 years (non-converters) or progressed to clinical AD-dementia within 5 years (converters). Clinical AD-dementia is defined as probable Alzheimer's disease established according to the National Institute of Neurological and Communicative Disorders and Stroke - Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) Alzheimer's Criteria. - . Similarity scores less than 50 indicate that a patient's inputs are more similar to those of the non-converter population. - Similarity scores greater than 50 indicate that a patient's inputs are more similar . to those of the converter population. - Patients with a similarity score close to 50 have inputs that are similar to both the . converter and non-converter aMCI patient populations used to develop and train the BrainSee device. The similarity score output is provided along with information to assist in the interpretation of the output to aid in evaluating the prognosis of patients diagnosed with aMCI to progress to clinical AD-dementia within 5 years. The BrainSee analysis is intended to provide supplemental information for interpretation in conjunction with a standard neurological assessment. Patient management decisions should not be made solely on the results of the BrainSee analysis. BrainSee is not indicated as a stand-alone diagnostic or prognostic tool. BrainSee should not be used to diagnose aMCI.

BrainSee is a software as a medical device (SaMD) intended to aid clinicians in evaluating the prognosis of patients diagnosed with amnestic mild cognitive impairment (aMCI). The software provides the clinician with a score between 0 and 100, which reflects the degree of similarity between the patient (in terms of cognitive profile and brain magnetic resonance imaging [MR]] features) and two reference aMCI patient populations of converters and non-converters that were used to develop the software. Conversion is defined as progression from aMCI to clinical Alzheimer's disease dementia (AD-dementia) within 5 years, where clinical AD-dementia is defined as probable Alzheimer's disease established according to the National Institute of Neurological and Communicative Disorders and Stroke - Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) Alzheimer's Criteria. To calculate the similarity score, BrainSee uses: - 1. Cognitive/behavioral test scores, including scores from the Mini-Mental State Examination (MMSE) and Clinical Dementia Rating Sum of Boxes (CDRSumBox) provided by the clinician. - 2. The patient's age and sex. - 3. Brain tissue volumes measured from T1-weighted brain MRI. BrainSee is offered to clinicians through a cloud-based platform. Clinicians access the platform via a web portal, where they can add patient records, enter the required clinical information, upload brain MRI scans, and view, download, and print the output report. BrainSee uses standard 3-dimensional T1-weighted MRI sequences obtained at 1.5 Tesla (T) or 3 T. and does not require any special MRI scan parameters, contrast agent, or additional hardware.