SNBL CPC Completes Validation Trial of NeuroCart CNS Test Battery

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SNBL Clinical Pharmacology Center, Inc. (SNBL CPC), a 96-bed clinical pharmacology research unit specializing in complex early-phase trials, announced today the successful completion of a validation study of the NeuroCart. The study validated the NeuroCart as an effective tool for detection of benzodiazepine-evoked pharmacodynamic CNS effects.

SNBL Clinical Pharmacology Center, Inc. (SNBL CPC), a 96-bed clinical pharmacology research unit specializing in complex early-phase trials, announced today the successful completion of a validation study of the NeuroCart. The study validated the NeuroCart as an effective tool for detection of benzodiazepine-evoked pharmacodynamic CNS effects.

The NeuroCart is a cognitive test battery that quantifies the physiological and psychological effects of CNS-active compounds using a centralized computer system. The NeuroCart uses the most informative and widely accepted tests – including electroencephalography (EEG), Visual Analogue Scales (VAS), and cognitive and memory testing – to create a profile of the pharmacodynamic effects of CNS-active drugs. This profile can be compared directly with plasma drug levels and side effects to provide data-intensive information about the activity of the compound and about its safety in humans.

The NeuroCart was developed by the Center for Human Drug Research (CHDR), a full-service CRO based in the Netherlands, through 20 years of practical application and clinical trial experience. The NeuroCart has been used to test a wide variety of CNS-active compounds in the EU and US, including therapeutics for sleep disorders, psychosis, addiction and Alzheimer’s syndrome. SNBL CPC is proud to be CHDR’s exclusive partner in offering the NeuroCart in the United States.

The study used the NeuroCart to evaluate the effects of lorazepam 2mg on sedation, cognition, and EEG in healthy male volunteers. The objective of the study was to validate the pharmacodynamic effects of oral lorazepam in healthy human volunteers using the NeuroCart. Pharmacodynamic effects were measured using saccadic peak velocity (SPV), smooth pursuit, pharmaco-electroencephalography (p-EEG), visual analog scales (VAS), tapping, adaptive tracking, body sway. The resulting data were compared and contrasted with previously published PD data obtained by the same methods in other studies and other physical locations of the NeuroCart to validate the stability and reproducibility of these measures at SNBL CPC. Furthermore, differences between Japanese (n=3) and American (n=5) subjects were explored and validated.

Results for all of the assessments above compared favorably with published PD data obtained by the same methodology in previously conducted studies, thereby validating the NeuroCart test battery as an effective tool for detection of benzodiazepine-evoked PD CNS effects. In addition, as previously established, the NeuroCart was found to be sufficiently sensitive to detect differences in benzodiazepine-evoked CNS effects on the basis of ethnicity, with differences observed for SPV, VAS composite scores, taps per 10 seconds and body sway. These results are consistent with previous studies that show inter-ethnic differences when using the NeuroCart.

The full CSR is available through:

George Debski
Vice President of Business Development
SNBL Clinical Pharmacology Center, Inc.
800 W. Baltimore St., 5th Floor
Baltimore, MD 21201
Email: gdebski(at)snbl-cpc(dot)com
http://www.snbl-cpc.com/

About SNBL CPC:

SNBL CPC is a 40,000 square foot, 96-bed clinical pharmacology research facility located in the University of Maryland BioPark in the heart of Baltimore, Maryland. Equipped with a state-of-the-art facility and bolstered by a vibrant research community, SNBL CPC specializes in complex Phase I-II trials, including TQT, FIH, and Challenge studies, in therapeutic areas including immunology/infectious disease, neurology, radiology, ophthalmology, endocrinology, and more. SNBL CPC conducts clinical trials from multiple sectors, including pharmaceuticals, biotechnology, academia, and the government. SNBL CPC offers full service support of clinical trials through its in-house resources, expert partners from surrounding universities and practices, and vetted subcontractors. These services include medical writing, recruitment, clinical conduct, regulatory submission, and data management.

For further information about SNBL CPC and how it can support your early phase drug development, please contact George Debski (gdebski(at)snbl-cpc(dot)com) or the client service team (bd(at)snbl-cpc(dot)com), or visit http://www.snbl-cpc.com.

About CHDR:

CHDR is a full service contract research organization (CRO) located in Leiden, the Netherlands. CHDR provides a full spectrum of high quality clinical pharmacology services to the (bio-) pharmaceutical industry. CHDR’s main focus is performing data-intensive, early phase, clinical studies where pharmacokinetic and pharmacodynamic parameters are obtained and combined. CHDR also conducts its own research, aimed at the development of biomarkers, methodology and technology under strict GCP conditions. CHDR specializes in First-in-Human, Proof-of-Concept, and PK/PD modeling studies. To obtain PK/PD parameters we develop, validate and use the latest techniques to provide the most accurate and highest quality data in early phase drug development. CHDR has developed a range of methodologies to provide detailed information about the effects of drugs on the central nervous system (CNS), including the NeuroCart.

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