As the COVID-19 pandemic spread, research teams worldwide quickly adapted study plans to safely continue research whenever possible. While some observational studies were put on hold entirely, other therapeutic trials were continued with many or all study activities occurring remotely.
Clinical Outcome Assessments in Preclinical Alzheimer’s Disease: Considerations for Global Clinical Trials
Clinical trials designed to study interventions at the preclinical AD stage are using fit-for-purpose clinical outcome assessments that have high validity and reliability for the detection of cognitive change at this early stage of the illness. This webinar outlines the application of several preclinical stage instruments for use in industry clinical trials.
Clinical trials in patients with rare disease present considerable challenges, as patients with these conditions are typically heterogeneous and many are quite impaired. In this webinar, Dr. Pamela Ventola describes important factors to consider when selecting cognitive and behavioral endpoints for these trials and shares strengths and application considerations for several key scales.
In clinical trials, changes in performance on cognitive tests can provide a sensitive index of the impact of a drug on the central nervous system. This webinar details how the detection of decline in specific aspects of cognition, or in cognition in general, is important for making decisions about target engagement, maximum tolerated dose and pharmacodynamic profile.
In recent years the neurocognitive effects of treatments for pediatric cancers have been acknowledged in the scientific literature. However, in many cases the magnitude of these deficits and the long-term impact on cognitive maturation remain unclear. In this webinar Dr. Adrian Schembri and Dr. Kristina Hardy share their collective experience on the application of computerized cognitive assessments in pediatric oncology.
The past two decades have seen multiple industry trials explore the impact of drug treatments on cognition in Parkinson’s disease and PD dementia. In this webinar, our speakers address important trends in the identification of patient populations suitable for trials of cognition-enhancing or disease-modifying therapies.
High-quality data are critical when seeking to measure treatment outcomes, but this is especially true and challenging in rare disease trials. This webinar outlines how clinical trial sponsors are incorporating leading-edge data capture and monitoring strategies to optimize clinical outcome assessments.
Selecting CNS Endpoint Measures in Pediatric and Rare Disease Clinical Trials: Key Considerations for Cognitive and Behavioral Assessments
Testing new medicines in children and patients with rare diseases presents considerable challenges, not the least of which is proper endpoint selection and measurement. This webinar discusses critical considerations when selecting developmental and computerized assessments for children.
The ABCs of Assessing Cognition in Oncology Clinical Trials: Applications, Benefits, and Considerations
Nearly all patients with central nervous system cancers experience cognitive problems during the course of their disease and treatment that can result in diminished quality of life and functional independence. This webinar discusses the role and relevance of cognitive endpoints in clinical trials to accelerate understanding of cognitive dysfunction related to cancer and cancer treatments.
Cognitive impairment associated with schizophrenia (CIAS) is an important treatment target, and major unmet therapeutic need in the chronic stages of schizophrenia. Many studies have sought to ameliorate CIAS with new drugs but, as yet, no drug has been approved for treatment of CIAS. This webinar outlines issues associated with the application of cognitive tests to guide decision making about the safety and efficacy of drugs in schizophrenia.
Subjective assessments in CNS clinical trials are prone to rater bias and variability that can cause failed or inconclusive trials. Hear from adult learning experts on “the science of learning” and how rater training programs can be radically improved to reach beyond the investigator meeting for on-demand access to rich, contextual, study- and population-specific rater guidance when and where it’s needed most.
The Preclinical Alzheimer Cognitive Composite: From Theory to Practical Application in Global Clinical Trials
Drug development strategies for early Alzheimer’s disease require clinical endpoints that are sensitive to the subtlest cognitive changes. Commonly used measures of cognition in clinical trials have inadequate measurement properties which render them insensitive to subtle change. This webinar discusses the PACC component tests, challenges to implementation and possible solutions and possible alternative component measures.