Innovations In Clinical Neuroscience

Summit 2017

A peer-reviewed, evidence-based journal for clinicians in the field of neuroscience

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BIOMARKERS AND IMAGING KINARM Labs: Better behavioral biomarkers using robot-based assessment Presenters: Lowrey C 1 , Early S 1 , V ivian-Scott A 2 , and Scott SH 1 ,2 Affiliations: 1 Queen's University, 2 BKIN Technologies Ltd., Kingston, Ontario, Canada Background/Objective: Measuring the efficacy of CNS therapeutics is challenging when assessment tools are coarse and have floor/ceiling effects. We developed interactive robotics as a next- generation technology to objectively quantify brain function. Design: KINARM Labs are clinic- friendly virtual reality robotic platforms that quantify arm movements while subjects perform motor actions. Nine behavioral tasks assess sensory, motor, and cognitive function in about one hour. Automated analyses quantify about 150 metrics of performance relative to a large cohort of controls. Twenty-six subjects who had experienced a stroke were assessed on all tasks in an acute care setting. Recovery patterns were measured by robotic and traditional measures. Results: Subjects displayed unique phenotypes with different patterns of impairment across sensory, motor, and cognitive domains. In general, robotic measures correlated with clinical measures, although some subjects with perfect clinical measure demonstrated impairments in the robot-based tasks. Ongoing studies highlight broad impairments associated with neurological diseases/injuries, such as Parkinson's disease, amyotrophic lateral sclerosis (ALS), syringomyelia, multiple sclerosis, and concussion. Studies to identify statistical significant change in each metric are also underway. Conclusion: This novel technology discriminates and quantifies subtle differences in behavior and neurological impairments in subjects afflicted with neurological injury/disease. KINARM assessments can be incorporated into multi-center trials (e.g., monitoring stroke motor recovery: NCT02928393). Further studies will determine if KINARM Labs can demonstrate a clinical effect with fewer subjects over a shorter trial p eriod. Disclosures/funding: Dr. Stephen Scott is the inventor of KINARM and CSO of BKIN Technologies. M ultiplexed mass spectrometry assay identifies neurodegeneration biomarkers in CSF Presenter: Chelsky D Affiliation: CSO, Caprion Biosciences, Inc., Montreal, Quebec, Canada Background/Objective: Early detection markers are critical for neurodegenerative diseases since substantial, irreversible damage to the brain occurs by the time of clinical diagnosis. Markers of disease progression are also important, as established clinical assessment tools can require a year or more to detect changes. Current efforts in our laboratory include developing such markers in Alzheimer's, Parkinson's, and Huntington's diseases. Design: Candidate biomarkers were identified in the literature for each disease, and targeted metabolic response modifiers (MRM) mass spectrometry assays were assembled. In the case of Huntington's disease, very few candidate markers were known in the literature, so a label-free liquid chromatography–tandem mass spectrometry (LC-MS/MS) discovery study was performed in cerebral spinal fluid (CSF) to identify novel markers. Results: In each comparison of disease and healthy control CSF samples, a subset of candidate biomarkers was verified. Results are described, including the affected proteins and pathways in each study and the similarities and differences in CSF proteins across the different diseases. Conclusion: A single, unified assay is now established that enables the multiplexed measurement of 205 neurodegenerative disease-related proteins in 50µL CSF. This can be deployed in support of clinical biomarker and drug development efforts. Disclosures/funding: This work was funded by the FNIH/Biomarkers Consortium, Michael J. Fox Foundation, and the NIH/NINDS. DIGITAL TOOLS/TECHNOLOGY Digital technologies in Alzheimer's disease trials Presenters: Kalali A 1 , Richerson S 2 , and Vahabzadeh A 3 A ffiliations: 1 C NS Summit, 2 Therapeutic Science and Strategy Unit, QuintilesIMS, 3 Brain Power Background/Objective: The landscape of clinical trials is evolving to improve the rate of success. This includes leveraging new technologies in multiple areas. Digital technologies in particular have an important role to play in the clinical trials of the future. The pharmaceutical industry has traditionally taken a conservative approach to the adoption of new technologies, with concerns about validity, acceptance by all stake-holders, and regulatory acceptance. This poster presents the areas where adoption of digital technologies creates new opportunities in clinical research. Design: We compiled a review of new technologies that could have an impact on clinical trials in Alzheimer's disease (AD). Conclusion: It is time that clinical trials in AD fully leverage digital technologies already available to researchers. If used effectively, digital technologies can have a wide-ranging positive impact on the conduct of clinical trials in Alzheimer's disease and their success. Industry-wide collaboration is needed to assess and validate the usefulness new technologies, including their applicability to clinical development. CNS Summit is one community seeking to collaboratively do this. One of the CNS Summit initiatives is the Connected Clinical Trials domain, which is producing a curated registry of connected devices, tools, and services of relevance to clinical trials. Other stakeholders including technology experts, patients, caregivers, investigators, and payers should be fully involved in these collaborative efforts. Disclosures/funding: Amir Kalali is an advisor to Bracket Global and AiCure. Sarah Richerson is an employee of Quintiles IMS. Arysha Vahabzadeh is an employee of BrainPower. ICNS Innovations in Clinical Neuroscience • November–December 2017 • Volume 14 • Number 11–12 • Supplement S5

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