Pharmaceutical Development HEADING_TITLE

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The news is filled with reports of failed CNS drug trials costing the pharmaceutical industry billions of dollars and depriving millions of patients of new beneficial therapies.  A primary reason for these failures (other than adverse side effects) is the difficulty in meeting clinically relevant endpoints during the trial.  This is partly due to the formidable task of designing a drug that can cross the blood-brain barrier and have the specific biochemical activity which will result in clinically measurable benefit to the patient.

The other reason that trials miss their endpoints is that the methods used to measure clinical effectiveness are often too noisy or insensitive to reliably capture the behavioral effects of the drug being tested.  This is especially true for disorders which present primarily as cognitive dysfunction such as Alzheimer’s, schizophrenia, ADHD, and Down syndrome.  This has led the pharmaceutical industry, with the support of the FDA, to pursue “biomarkers” as surrogate measures of clinical effect.

According to The Biomarker Consortium,biomarkers may be used to help determine how a drug works in the body, to determine a biologically effective dose of a drug, to help assess whether a drug is safe or effective, and to help identify patients most likely to respond to a treatment.

Most neuro-biomarkers (such as those derived from MRI, FDG PET, amyloid PET, and cerebral spinal fluid analysis) are measures of brain structure, metabolism, or biochemistry.  While these measures are important in certain neurological disorders, they are relatively useless as measures of cognitive function.  Quantitative electroencephalography (QEEG) and event-related potentials (ERP) are direct physiological measures of the information processing functions in the brain and are therefore very useful “cognitive biomarkers”.

The successful development of pharmaceuticals to treat cognitive disorders relies upon sensitive, reliable, reproducible measures of the cognitive effects of treatment.  These measurements must be able to be captured in large-scale clinical trials by minimally trained clinical staff and in a cost-effective manner.  These complex, real-world requirements represent a unique opportunity for COGNISION™.

COGNISION™ test data can provide the following benefits in many pharmaceutical trials:

  • Physiologic measures of fundamental cognitive processes (such as attention, working memory, etc.)
  • Sensitive to pharmacodynamic activity to provide more informed Go/No-Go decisions in early stage trials
  • Reliable measure of disease progression or interventional effect
  • High SNR of cognitive processes can reduce trial size and/or shorten duration to reduce product development costs
  • Not effected by communication difficulties, rater bias, or other common behavioral confounds
  • Repeatable and reliable across study sites and all data centralized for collaborative efforts
  • Non-invasive, easy, and quick to obtain

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