Studies of investigational drugs targeting the dementia stage of Alzheimer’s disease (AD) have used a co-primary approach to assess cognitive and functional (or global) measures. This approach ensured both a clinically meaningful effect by a demonstration of benefit on the functional measure and that the observed functional benefit was accompanied by an effect on the core symptoms of the disease as measured by the cognitive assessment.
Clinical Trials of Schizophrenia: Optimizing Patient Reported Outcomes and Performance Outcome Assessments
The majority of clinical outcome assessments (COAs) in schizophrenia trials are clinician reported outcome (ClinRO) assessments such as the PANSS and various forms of CGI and functional instruments which use information from clinical interviews with the patient and perhaps a caregiver. These COAs provide critical insights into clinical status, making use of the expertise and insight of psychiatrists and other healthcare professionals.
There is now conjecture that disease-modifying therapies for AD may be most effective in the preclinical stages of the illness and therefore drug development programs are focusing on this stage of the disease. The large effects of amyloid observed on learning paradigms over short time periods suggests they could be a useful cognitive challenge model for early phase studies seeking to understand the effects of drugs designed to improve cognition in AD.
Advances in treatments are substantially increasing survival rates in people with cancer. While indices of overall survival and progression-free survival are the most widely accepted clinical endpoints for determining the efficacy of new therapies in oncology, there is growing interest in patient-centered clinical outcome assessments (COAs) to determine the potential benefits and safety of new and existing treatments as well as their effects on level of overall function.
Substantial progress has been made in the development of disease modifying therapeutics for Multiple Sclerosis (MS) in recent years. The array of next-generation compounds for this complicated disease have made great strides in increasing the time between relapse and delaying disease progression.
High-quality data are critical when seeking to measure treatment outcomes, but this is especially challenging in rare disease trials where the stakes are high with complex assessments and a limited number of eligible participants. In this webinar, Dr. Pam Ventola will describe customized rater training approaches that meet sponsors’ needs but also are flexible and efficient so to be feasible for sites.
Learn how to leverage integrated digital cognitive assessments and patient reports for advanced insights, streamlined delivery and lower burden. Watch the webinar from ERT and Cogstate to learn the value of assessing cognitive safety and tolerability throughout the drug development process, key considerations for selecting and optimizing computerized cognitive assessments, and more.
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.
Cogstate senior scientists came together (digitally) from three continents to discuss clinical outcome assessments in the COVID-19 era. We invite you to watch the video of their roundtable discussion.
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.