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Cognitive Testing in Clinical Drug Trials: Successful Test Selection and Integration In-house Training

An excellent opportunity to hear from two renowned cognition experts and gain a better understanding on the selection and successful integration of cognitive testing into therapeutic development programmes, as well as the emerging science of blood-based biomarkers.

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Course overview

Cognitive assessment has long been a key efficacy measure in clinical trials of indications such as Alzheimer’s disease (AD). In the past few years, the use of cognitive efficacy measures has been extended to indications including Schizophrenia, Depression and Lewy body Dementias. The use of cognitive assessment has also been extended to the assessment of safety, especially in cardiology. Cognitive assessment has been employed with variable success and a hallmark of failed examples has been the use of tests with poor reliability, validity and sensitivity. 

The emergence of blood-based biomarkers (BBBM) for the detection of the early changes of AD has been a pivotal moment in dementia research. Early studies have shown that these BBBM have a high degree of sensitivity and specificity for identifying early changes of AD before the clinical signs such as memory loss are apparent. Existing studies have been undertaken using large research cohorts, so the impact of these BBBMs may have in the real-world is still unknown. Despite this, BBBMs pave the way for early diagnosis and better recruitment into clinical trials. 

In this webinar, as well as exploring the emerging blood-based biomarker breakthrough, we will review examples of both successful and failed case studies. We will conclude with recommendations for cognitive test selection and its successful integration into clinical drug trials.

This is an excellent opportunity to hear from two renowned cognition experts and gain a better understanding on the selection and successful integration of cognitive testing and blood-based biomarkers into therapeutic development programmes.

Browse our extensive selection of Life Sciences training courses for industry-leading insights into a range of topics. These include Medical Devices, IVDs, Biotech and Biopharma, Animal Health and Pharmaceutical training courses.

Benefits of attending

  • Understand the increasing importance of cognitive testing in clinical drug trials
  • Explore more about cognitive test selection and how to successfully integrate cognitive assessment in therapeutic development programmes
  • Dive into the science behind the development of BBBMs for AD
  • Learn more about how these BBBM may change Alzheimer’s disease is diagnosis and improve recruitment into therapeutic clinical trials
  • Obtain an opportunity to the impact these BBBM may have on diagnostic and therapeutic pathways with an expert in the field
  • Gain an opportunity to discuss the complexities of cognitive assessment with two experts in this field

Who should attend?

  • Sponsor personnel responsible for diagnostic test selection and integration
  • CRO and site personnel involved in CNS clinical trials
  • Industry analysts, regulators, journalists and anyone interested in discovering more about recent developments in the diagnosis of AD

Programme

This course will cover:

What is cognition?

  • A review of the various domains and their relevance to specific indications

What makes a good cognitive test

  • A review of issues: reliability, validity, and sensitivity

Case studies

  • Measuring cognition in AD trials – a critical review
  • Brintellix: successful development of cognitive labelling for an anti-depressant
  • Evaluating safety in cardiology safety studies, the example of Valsartan

The emergence of blood-based biomarkers (BBBM)

  • The science behind BBBMs and how they are being used to identify early changes of AD 
  • Discuss early and existing studies that have been undertaken using large research cohorts
  • How the impact that BBMS may have in the real-world is still unknown
  • The benefits of BBBMs: paving the way for early diagnosis and better recruitment into clinical trials

Recommendations for cognitive test selection and its successful integration into clinical drug trials

John E. Harrison
Scottish Brain Sciences

Professor John Harrison is an acknowledged cognition expert whose principal professional interest is in helping people understand, maintain, and enhance their cognitive skills. He is Chief Scientific Officer at Scottish Brain Sciences where he advises on the selection and successful integration of cognitive testing into therapeutic development programs. John is an Associate Professor with the AUmc Alzheimer Center and Visiting Professor at King’s College London. He holds Chartered Psychologist status and has authored/co-authored more than 100 books and scientific articles, including a popular neuroscience book ‘Synaesthesia: The Strangest Thing’. John’s wider professional activities include conference hosting, professional voiceover acting and podcasting.

Social media links:

http://www.linkedin.com/in/drjohnharrison

http://open.academia.edu/JohnHarrison

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Alison Green
Scottish Brain Sciences

Dr Alison Green is a clinical biochemist with over 30 years’ experience of working within the NHS and academia to develop and evaluate diagnostic tests for neurodegenerative diseases. She did her PhD at the National Hospital for Neurology and Neurosurgery in London looking investigating the role of biomarkers in the diagnosis of dementia. After her PhD, Alison ran the international diagnostic service for Creutzfeldt-Jakob disease within the University of Edinburgh. She is currently working at Scottish Brain Sciences where she is collaborating with Roche Diagnostics Ltd to evaluate the performance of newly emerging blood tests for Alzheimer’s disease.

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United States of America

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Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra Beer

Aleksandra BEER
Training expert

Yesim Nurko

Yesim NURKO
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy