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 digital cognitive assessments, 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 Clario 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 Clario’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.

Sample Parkinson’s Disease Battery

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.

Cogstate Tests:International Shopping List Tests
Detection Test
Identification Test
One Card Learning Test
One Back Test
Two Back Test
Groton Maze Learning Test
Length:Between 5-40 minutes
(depending on the number of tests included in the battery)
Administration:Standardized
Data Processing and Scoring:Automated
Application:Phase I-IV
Culture and Language Neutral:Yes

EXPLORE OUR 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

Parkinson’s Disease Resources

[Blog]

Parkinson's Disease Clinical Trials Services and Resources

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[Webinar]

Evaluating Cognition in Parkinson’s Disease Clinical Trials

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[Fact sheet]

Parkinson’s Disease Clinical Trial Solutions from Cogstate

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Featured Publications

Safety of Plasma Infusions in Parkinson’s Disease

Authors: Jordan E Parker, Amaris Martinez, Gayle K Deutsch, Varsha Prabhakar, Melanie Lising, Kristopher I Kapphahn, Chioma M Anidi, Raumin Neuville, Maria Coburn, Neil Shah, Helen M Bronte-Stewart

Journal: Movement Disorders

Year Published: 2020

Background: Young plasma infusions have emerged as a potential treatment for neurodegenerative disease, and convalescent plasma therapy has been used safely in the management of viral pandemics. However, the effect of plasma therapy in Parkinson’s disease […]

Physical activity and cognition in young-onset Parkinson’s disease

Authors: Karen J Biddiscombe, Ben Ong, Pawel Kalinowski, Kerryn E Pike

Journal: Acta Neurologica Scandinavica

Year Published: 2020

Background: A relationship has been observed between physical activity and cognition in older-onset Parkinson’s disease, as well as improvements in cognition after a physical activity intervention. To date, this has not been investigated in young-onset Parkinson’s […]

A Placebo-Controlled Trial of AQW051 in Patients With Moderate to Severe Levodopa-Induced Dyskinesia

Authors: Claudia Trenkwalder, Daniela Berg, Olivier Rascol, Karla Eggert, Andres Ceballos-Baumann, Jean-Christophe Corvol, Alexander Storch, Lin Zhang, Jean-Philippe Azulay, Emmanuel Broussolle, Luc Defebvre, Christian Geny, Michal Gostkowski, Fabrizio Stocchi, Christine Tranchant, Pascal Derkinderen, Franck Durif, Alberto J Espay, Andrew Feigin, Jean-Luc Houeto, Johannes Schwarz, Thérèse Di Paolo, Dominik Feuerbach, Hans-Ulrich Hockey, Judith Jaeger, Annamaria Jakab, Donald Johns, Gurutz Linazasoro, Paul Maruff, Izabela Rozenberg, Judit Sovago, Markus Weiss, Baltazar Gomez-Mancilla

Journal: Movement Disorders

Year Published: 2016

Background: This phase 2 randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of the nicotinic acetylcholine receptor α7 agonist AQW051 in patients with Parkinson’s disease and levodopa-induced dyskinesia. Methods: Patients with idiopathic Parkinson’s disease and […]

AFQ056 in Parkinson patients with levodopa-induced dyskinesia: 13-week, randomized, dose-finding study

Authors: Fabrizio Stocchi, Olivier Rascol, Alain Destee, Nobutaka Hattori, Robert A Hauser, Anthony E Lang, Werner Poewe, Mark Stacy, Eduardo Tolosa, Haitao Gao, Jennifer Nagel, Martin Merschhemke, Ana Graf, Christopher Kenney, Claudia Trenkwalder

Journal: Movement Disorders

Year Published: 2013

AFQ056 is a novel, selective metabotropic glutamate receptor 5 antagonist. This was a 13-week, double-blind, placebo-controlled study. Patients with Parkinson’s disease and moderate-to-severe levodopa (l-dopa)-induced dyskinesia who were receiving stable l-dopa/anti-parkinsonian treatment and were not currently […]

Memantine for patients with Parkinson’s disease dementia or dementia with Lewy bodies: a randomised, double-blind, placebo-controlled trial

Authors: Murat Emre, Magda Tsolaki, Ubaldo Bonuccelli, Alain Destée, Eduardo Tolosa, Alexandra Kutzelnigg, Andrés Ceballos-Baumann, Slobodan Zdravkovic, Anna Bladström, Roy Jones, 11018 Study Investigators

Journal: Neurology

Year Published: 2010

Background: Previous studies have suggested that patients with Lewy-body-related dementias might benefit from treatment with the N-methyl D-aspartate receptor antagonist memantine, but further data are needed. Therefore, the efficacy and safety of memantine were investigated in […]

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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

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Digital Cognitive Assessment

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Rater Training

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Central Monitoring

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Scale Management

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Remote / At-home Testing

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