Review of Recent FDA Draft Guidance for Rare Disease Clinical Trials
April 22, 2019
In this video, Dr. Pam Ventola reviews two recent FDA draft guidances for rare disease drug development, where she highlights the need for indication-specific outcomes, as well as how to get the most from natural history studies to determine acceptability/feasibility of endpoints and to inform future trial designs.
Cogstate Battery Used to Assess Cognition in Traumatic Brain Injury Patients in Uganda
February 28, 2019
Worldwide, traumatic brain injury (TBI) has become a leading cause of death or disability with road traffic accidents causing the majority of these injuries. In fact, accidents from car or motorcycle crashes is now the 10th leading cause of disability adjusted life years (DALYs), up two places in just the last twenty years. However, across […]
Cogstate Tests Show No Cognitive Impairment from Use of Lorlatinib for the Treatment of Non-Small-Cell Lung Cancer
January 16, 2019
During the drug development process, it’s important to characterize the nature and magnitude of any adverse effects a drug may have on cognition, even if the underlying disease is not brain-related. However, many Phase 1 and Phase 2 clinical trials do not incorporate objective, performance-based cognitive measurement tools as part of their safety assessment. Cognitive […]
Reliable and Valid Cognitive Test Results Obtained from MS Patients Performing Self-Administered Computerized Assessment
December 19, 2018
Cognitive dysfunction occurs in more than half of all people with multiple sclerosis (MS) and correlates to brain lesion volumes and atrophy. Given the significant impact that these changes can have on a person’s quality of life, relationships and employment, early and ongoing assessment of cognition is important and represents an unmet need for MS […]
Cogstate Battery Demonstrates Sensitivity in Detecting Therapy-related Changes in Pediatric Neuro-oncology Patients Undergoing Radiation Treatment
December 16, 2018
With survival rates above 70 percent for pediatric medulloblastoma patients, there are now treatment options that offer hope for resumed childhoods and normal learning experiences into adolescence. However, one of the unfortunate side effects of both the tumor and the treatment is a risk of cognitive deficits. These deficits typically are not a loss of […]
Cognitive Change Associated with Anesthesia and Surgery: Establishing a Common Nomenclature
November 5, 2018
In this video, Prof Paul Maruff, PhD, Chief Science Officer at Cogstate, updates us on an important new publication that provides a framework for understanding central nervous system changes that occur in the perioperative environment (i.e. disorders associated with factors related to a hospital admission for surgery, the conduct of surgery and anesthesia, discharge from the […]
Measuring Cognition in Pediatric Oncology Trials: Topics, Trends and Key Takeaways from the Children’s Oncology Group (COG) Fall Meeting
October 11, 2018
Data from Brain Health Registry show utility of online unsupervised cognitive testing using the Cogstate Brief Battery in older adults
August 10, 2018
As life expectancies around the world increase, our brains become more susceptible to age-related disorders such as Alzheimer’s disease (AD), and the earliest symptoms can be subtle. The research efforts for therapies that slow or prevent AD involve large clinical trials that require participants who have the disease but who are experiencing only very […]
Trial Design of PCSK9-inhibitor, Evolocumab, in Pediatric Patients with Heterozygous Familial Hypercholesterolemia
June 18, 2018
In this video, Prof Paul Maruff discusses a recently published paper which details the design of a study investigating the PCSK9-inhibitor, evolocumab, in pediatric patients with heterozygous familial hypercholesterolemia. The FDA has been investigating reports of cognitive impairment associated with the use of lipid-lowering medications for several years, and while they did not link statins […]
Structured Exercise Program Improves Cognitive Functioning for Patients with First-Episode Psychosis
June 6, 2018
While exercise is a proven partner in good brain health, its benefits are now being studied in more specific neurological disorders. Swedish and Australian researchers recently published a new study on the effects of an organized exercise program on a group of adults diagnosed with first-episode psychosis. Results showed a positive relationship between exercise and […]
Study Shows Similar Symptom Profile in Ketamine Dependence with Persistent Psychosis and Schizophrenia
March 28, 2018
Researchers measured psychosis (PANSS) and cognitive impairments (Cogstate), and the symptom profile of persisting psychosis due to chronic heavy ketamine abuse resembled that of schizophrenia Enormous interest has recently been focused on a potential role for ketamine in treating depression. A non-opioid anesthetic with a long track record, ketamine may now present an entirely new […]
Studies Show Healthy Lifestyle Program Can Slow Cognitive Decline
February 11, 2018
As we age, a healthy lifestyle becomes more important to not only keep our body in shape but also to protect our brain from decline. Previous studies have shown that nutrition, physical workouts and cognitive exercise can benefit both our muscles and our mind. For the brain, a proactive daily program can slow the effects […]
Strategic Central Monitoring of Psychometric Tests and Rating Scales
January 17, 2018
Even when employing the most intensive rater training program, many raters may still make errors in administering and scoring some psychometric tests and rating scales in clinical trials. Cogstate Central Monitoring helps ensure the highest possible data quality through rigorous expert review — acting as an extension of the rater training program. Our central monitoring […]
Stay Hydrated Throughout The Day For Better Cognitive Performance
January 10, 2018
Right up there with taking ten thousand daily steps, drinking enough water is another recommended health goal to include in your New Year’s resolutions. While many of us try to maintain our weekly average hydration through the foods and beverages we consume, there can be fluctuations throughout each day, caused by our work or exercise […]
Key Advantages of Computerized Cognitive Testing in Clinical Trials
December 6, 2017
Cogstate computerized cognitive tests have been designed and validated to withstand the numerous operational challenges of conducting clinical trials — dramatically increasing the sensitivity and specificity of the measurement of cognition in clinical research. The tests are highly standardized for non-expert administration, rapid and repeatable with limited learning effect, and the novel stimuli and translations […]
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