CDR System

The Signant SmartSignals® Cognitive Drug Research System (CDR System®) is the industry-leading computerized cognitive testing platform designed specifically for clinical trials. With over 35 years of history, the CDR System was the first computerized solution to challenge paper-and-pencil neuropsychological testing, introducing groundbreaking millisecond reaction time measurement, electronic data capture, and parallel forms for repeated administration to address learning effects. Its widespread adoption has generated the industry's largest normative database, spanning the broadest range of therapeutic areas and enabling meaningful interpretation of cognitive test findings.

The next-generation web-based CDR System uses keyboard input to deliver the same proven administration speed and millisecond accuracy as its predecessor, while offering easier logistics and administration. Validated in over 50 languages and supported by Signant's medical and scientific experts, the CDR System is suitable for any trial, any indication, and any testing schedule — from healthy volunteers to patients with dementia.

Cognitive Domains Assessed

• Attention: Measures the ability to focus concentration and sustain intensive attention.
• Information processing: Evaluates the speed and accuracy of processing incoming information.
• Episodic and working memory: Assesses memory functions essential to everyday activities.
• Executive function: Tests higher-order cognitive abilities including problem-solving and personal care tasks.

Key Features and Capabilities

• Highly sensitive detection: Specifically designed to identify subtle changes in cognitive function across any participant population when administered repeatedly throughout a study.
• Brief assessment duration: Each assessment takes 30 minutes or less depending on battery content, reducing participant burden.
• Fast administration: The attention battery can be administered in 7 to 30 minutes by non-specialists.
• Tailored battery content: Battery content can be customised to meet the specific needs of each study protocol.
• Bidirectional sensitivity: The CDR System can assess both potential cognitive deficit and cognitive improvement, as demonstrated by frequent use in Phase I clinical research studies.
• Disease-agnostic: Suitable for any population, from healthy volunteers and patients with minor cognitive impairment to those with dementia.
• Multiple parallel forms: Provides multiple parallel forms for each test to address the challenge of learning effects across repeated administrations.
• Multilingual validation: Validated in over 50 languages to support global clinical trials.

Cognitive Safety Assessment Battery

• Signant's attention tests have been used in over 500 cognitive safety assessments over the last 35 years, with some used to support product labelling across a broad range of therapy areas.
• Simple Reaction Time: Measures alertness and the ability to focus concentration.
• Digital Vigilance: Measures sustained and intensive attention.
• Choice Reaction Time: Measures alertness, the ability to focus concentration, and information processing speed.

Why Choose the CDR System

• Reliable data: Produces data that is more reliable and measurable than paper-based methods.
• Industry-leading normative database: An extensive normative database combined with a broad list of publications enhances interpretation of study data.
• Scientific expertise: Signant's medical and scientific experts assist in selecting the right battery of tests for each study's objectives and patient population, and help interpret the effect of a drug or therapy on cognitive function and safety.
• Automatic data upload: Data are automatically uploaded to a secure database and immediately available for analysis.

Approaches to Cognitive Assessment in Clinical Trials

• Self-report measures: Questionnaires completed by the participant themselves.
• Informant-report measures: Scales completed by caregivers or observers, such as ECog.
• Performance-based measures: Sensitive computerised clinical assessment batteries, such as the CDR System, designed to detect subtle cognitive changes applicable across any trial and any indication.
• Indication-specific scales such as ADAS-COG are also commonly used in conditions like dementia.

The CDR System is delivered as a web-based solution, enabling straightforward deployment across global clinical trial sites. Its secure database infrastructure ensures immediate data availability for analysis, and its extensive publication record and normative database support robust scientific interpretation of findings across a wide range of therapeutic areas, including Alzheimer's disease research.