Literature Spotlight: Using Cogstate Computerized Tests to Identify Cognitive Impairment in Alzheimer’s Disease Clinical Trials
Cogstate computerized tests have been used extensively as rapid and reliable screening assessments in a range of clinical indications, including Alzheimer’s Disease (AD), Mild Cognitive Impairment, and Dementia. The tests are well-validated assessment options for study teams looking for an efficient and effective way to identify cognitive impairment in all phases of AD clinical trials.
Cogstate’s clinical trial services, coupled with innovative operational approaches, advanced analytics and scientific consulting, help research teams draw conclusions from study data faster and with more accuracy.
Conventional clinical outcome assessments play a critical role in understanding the effects of new investigational therapies, but their administration can be vulnerable to variability and scoring errors.
Cogstate has supported more than 90 studies of Alzheimer’s disease, spanning the spectrum of disease stages and in all phases of clinical development. Learn more about how we work with study teams to drive new innovations that increase the chance for study success.
Rare and orphan disease research represents the fastest growing area of drug development, but these studies face significant challenges including endpoint selection and measurement. Learn how Cogstate supports the unique challenges of studies in these indications.
Cognitive impairment affects 50-70% of Multiple Sclerosis patients and is noted as one of the most disabling aspects of the disease. Learn how Cogstate provides digital cognitive testing and supports conventional assessments for clinical trials in MS.
Cogstate helps sponsors gather high quality data in PD trials by providing digital cognitive testing and supporting the full range of conventional clinical outcome assessments including motor function, quality of life, cognition, depression, suicidality, symptom severity, and sleep.
Cogstate helps sponsors better evaluate cognitive impairment throughout the development lifecycle of new oncology therapeutics in both adult and pediatric populations by providing sensitive and reliable computerized cognitive testing, alongside supporting patient reported outcomes.
Cognitive dysfunction is a central feature of schizophrenia and addressing cognitive impairment is a major unmet medical need in the development of therapies for people with schizophrenia. Learn more about how Cogstate supports sponsors in these efforts via digital assessment.
From rapid start-up timelines to tightly orchestrated protocols, Cogstate technology is designed to support the unique requirements of early phase research. Learn how sponsor teams use our validated cognitive assessments and support services to gather sensitive and reliable data.
Test selection is a key component of pediatric rare disease clinical trial development. Assessments need to be appropriate for the functioning level of the population and also have adequate sensitivity and specificity to detect change over time in the target population.
Selecting, acquiring and translating the appropriate rating scale instruments for a study is a meticulous process of great consequence. Learn about Cogstate’s experience and partner relationships that enable us to provide superior scale acquisition and management services for clinical trials.
Efficient rater training and data quality monitoring practices can help study teams improve signal detection and optimize budgets in rare disease trials. Read case examples from a range of rare disease studies that show tailored and efficient rater training and data monitoring approaches.
Data Quality, Rater Training and Regulatory Expectations: Basic Principles and Good Clinical Practice for CNS Clinical Trials
Clinical outcomes, particularly complex clinician-rated scales, are subject to variability and error due to a myriad of issues, making it less likely that a study will yield reliable, statistically significant results. Robust rater training and certification protocols are suggested to ensure greater standardization and reliability.
Using Cognitive Assessments in Early Clinical Development to Evaluate Drug Effects on the Ability to Operate a Motor Vehicle
Many classes of drugs designed to act on the central nervous system (CNS) may also disrupt cognition. A directly related public health priority is the need to assess the potential of a compound to impair a person’s ability to operate a motor vehicle.