World Drug Safety Conference hears call for wider use of cognitive safety testing in drug development

In a call to the pharmaceutical industry at the World Drug Safety Conference in Chicago last week (April 22-23 2015), a leading developer of cognitive assessment software, Cambridge Cognition plc, stressed the increasing regulatory and clinical need to expand cognitive safety testing beyond CNS-targeted drugs.

Speaking to an international audience of drug safety and pharmacovigilance experts, Dr. Kenton Zavitz, Director of Clinical Affairs at Cambridge Cognition, highlighted new evidence that many drugs treating conditions including cardiovascular disease, allergies, diabetes and cancer may result in cognitive impairment with potentially serious consequences for patient safety. Dr Zavitz called for these effects to be monitored closely and fully characterized in the drug development process with monitoring continuing once such drugs are used routinely, particularly in vulnerable populations such as the elderly.

“Cognitive function is critical for day-to-day life; governing our thoughts and actions,” Dr. Zavitz said. “Using innovative tools like Cantab Connect, we can objectively assess and monitor an individual’s cognitive abilities such as memory, attention and decision making and the effects that different drugs have on them. Increasingly we are seeing evidence that this is relevant not only for those therapeutics that target directly neurological disorders such as Alzheimer’s disease. Compounds that function to modulate the heart or affect breathing, the immune system and glucose or cholesterol transportation can all have significant cognitive effects. There is also evidence that many common medical conditions such as diabetes and hypertension - and the ageing process itself – can affect the integrity of the blood brain barrier, which protects the brain from toxic molecules and infectious agents. Thus, new drugs may have unanticipated effects on brain function and cognition. Increasingly, many drug developers in the pharmaceutical industry are aware that cognitive assessment should be included in the drug development process more broadly since such information can make essential contributions to early decision making, dose selection and the selection of suitable patient populations for further study.”  

In addition to a call for wider cognitive safety testing in clinical trials, Dr. Zavitz also highlighted the effects of drugs on cognitive function in the elderly as a particular area of concern: “They are most vulnerable to deficits in memory and are typically taking multiple medications that can act synergistically to impair cognition. It has been reported that 30% of the over 65s are now prescribed 6 or more concurrent drugs. One of our recent studies on the cognitive effects of combined benzodiazepine and an antipsychotic medication showed reaction times slowing to the equivalent of being over the drink-drink driving limit. Therefore we advocate wider studies of the cognitive effects of poylpharmacy.” 

The Cantab Connect range of iPad-based clinical trial information systems is designed for ease of use in clinical research studies. The sensitive touchscreen tests of cognitive function are language independent, objective and administered automatically to reduce variables that might impede data quality. All data is recorded and stored securely, scored and uploaded to a Cloud storage platform compliant with GCP and 21 CFR part 11 standards for electronic records and signatures. Efficiently providing researchers with real time access to reliable data from global sites, Cantab Connect is reducing risks and increasing data quality assurance and enabling more informed decisions to be made in the development of drug treatments that are both safe and effective. 

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