Parkinson’s Disease

Improving the Measurement of Clinical Outcomes with Higher Fidelity Measures

While motor function is a hallmark of Parkinson’s disease (PD) clinical trials, drug development efforts are increasingly addressing additional aspects of the disease including cognitive impairment, as patients note these symptoms as being among the most impactful aspects of living with PD.

Cogstate helps sponsors gather high quality data in PD trials by providing sensitive and reliable computerized cognitive testing, as well as supporting rater training, central monitoring, and eCOA for the full range of clinical outcome assessments including motor function, quality of life, cognition, depression, suicidality, symptom severity, and sleep.

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Optimize Clinical Outcome Assessment in Parkinson's Disease Clinical Trials

Cogstate’s team of scientific and operational experts deliver innovative technology, proven operational delivery models and leading scientific support for both digital and conventional clinical outcome assessments in PD trials.

Leverage Sensitive and Reliable Computerized Cognitive Batteries

Cogstate’s computerized batteries of highly sensitive tests provide rapid and reliable measurement of distinct cognitive domains affected by PD such as processing speed, attention, verbal and visual learning, working memory, visual motor function, executive function, and social cognition. Tests can be grouped into customizable batteries for a complete and nuanced picture of a subject’s cognitive state. Cogstate tests are culture- and education-neutral and designed for repeated administration with minimal practice or learning effects, making them ideal for use in global clinical trials. Tests have high patient acceptability and reduce burden on patient and sites.

Implement Robust Data Quality Programs for Conventional Assessments

Subjective assessments in PD studies create the potential for variability in administration and scoring that may compromise the integrity of a clinical trial. Cogstate supports all aspects of data quality programs for PD cognitive and motor assessments—rater training and certification, subject eligibility review, central monitoring—with proven methodologies and leading technologies that drive endpoint reliability. Cogstate has expertise collaborating with the Movement Disorder Society (MDS) to coordinate training on commonly used MDS scales including the MDS-UPDRS and UDysRS; we have produced training materials on commonly used scales in PD studies (e.g., PDQ-39, PDSS-2, etc). Studies also benefit from our global network of Local Expert Advisors (LEADs) who are highly trained clinical and scientific experts that provide assessment support in 40+ languages.

Select Validated, Fit-For-Purpose Outcomes Measures

Choosing appropriate endpoints and designing strategic protocols are important decisions in the planning phase that impact future study results. Cogstate’s team of scientists have the expertise to advise your team on vital study considerations, help you answer key drug development questions, and design trials with reduced risk and uncertainty.

Support Electronic Deployment of Assessments via eCOA Systems

Cogstate partners with industry leading eCOA providers to deliver enhanced tablet-based scales and web-based eSource solutions, combining user-friendly interfaces with secure and reliable data management platforms. Custom edit checks and automated scoring help prevent errors, and same day access to cleaner source data enables risk-based central monitoring by our clinical experts for greater quality assurance.

Wearable Sensors for a Complete Picture of Patient Functioning

Cogstate’s strategic partners at ERT deliver a complete wearable precision motion sensor solution that provides meaningful and functional insights for sponsors and patients through the capture of digital biomarkers. When integrated with Cogstate’s clinical outcome assessments of cognition or ERT’s data capture solutions for cardiac safety, eCOA, digital patient, imaging, or respiratory, digital biomarkers provide a holistic story of how a disease and therapy impacts patient function.

Parkinson’s Disease Batteries

Cogstate tests are organized into batteries that assess the cognitive domains affected by PD, such as processing speed, attention, verbal and visual learning, working memory, visual motor function, executive function, and social cognition.

Cogstate tests are rapid, reliable, simple and sensitive. Each test has been shown to be valid for use in different cultures and language groups with comparative/normative data available for both clinical samples and healthy controls. Tests have been used in all phases of drug trials and maintain excellent reliability across repeated testing and cross-sectional research designs.

Battery recommendations for PD studies vary depending on the stage of the disease and the study’s focus area. Batteries take between 5-40 minutes to complete (depending on the tests included), have standardized administration, and automated data processing and scoring.

Example PD Cognitive Battery

  • International Shopping List Tests [Verbal Learning]
  • Detection Test [Psychomotor Function / Processing Speed]
  • Identification Test [Attention]
  • One Card Learning Test [Visual Learning]
  • One Back Test [Working Memory]
  • Two Back Test [Working Memory]
  • Groton Maze Learning Test [Executive Function]

WATCH DEMOS OF OUR COMPUTERIZED TESTS

Decentralized Clinical Trials

We help bring the trial to the patient

As more clinical trials realize the potential of decentralization, Cogstate digital endpoints are enabling at-home, self-administered assessment and our remote rating services are enabling at-home clinician-administered assessment to drive both enhanced data quality as well as patient enrollment, engagement and retention.

SEE HOW WE CAN SUPPORT YOUR FULLY REMOTE OR HYBRID TRIAL DELIVERY

Solutions for Every Stage of Your Study Development

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. Learn how we can support your study:

Scientific Consulting

Computerized Cognitive Assessment

Rater Training

Central Monitoring

Scale Management

Remote / At-home Testing

How can we help you optimize the measurement of brain health?

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