Digital Cognitive Assessment

Replace costly and complex paper cognitive assessments with a rapid and reliable digital solution from Cogstate. Doing so, you gain simpler operations, cleaner data, and reduced burden for patients and sites.

Cogstate tests can detect subtle drug-related changes, are culture-neutral, designed for repeated administration, do not require expert neuropsychologist raters, and can be rapidly set-up across all your sites. Data from our tests have been used to support successful regulatory interactions and product approvals.

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Cogstate Digital Tests are Scientifically Validated and Operationally Efficient…

Can be administered repeatedly with minimal practice or learning effects

Can be used at sites that have limited cognitive testing experience

Are brief and can fit into tight protocol schedules

Use novel stimuli to ensure assessment is culture-neutral and not limited by education

Case Studies of Digital Assessment in Action

Cogstate digital tests have been leveraged across all phases of clinical trials to help research teams answer critical study questions around safety and efficacy. Data from the tests have been seen and accepted by regulators. Tests are effective and equivalent when deployed inside or outside the clinical site (remote). The following case studies represent only a handful of the many ways our digital cognitive tests are leveraged.

Ph 1 Cognitive Safety and REMS

Cogstate tests were used in the Phase 1, 2-period crossover study of intranasal esketamine to evaluate any potential cognitive effects. Subjects were tested multiple times in short succession. At 40-minutes post-dose there was a significant difference in cognition from placebo, and at 2-hours post-dose no significant difference in cognition was found between groups. This cognitive safety data contributed to the Risk Evaluation and Mitigation Strategy (REMS) of intranasal esketamine. (Bahr, R., et al., Pharmacy and Therapeutics, 2019: PMCID: PMC6534172) 

Patient Selection and Enrollment for Ph 3 Global Program

The Cogstate International Shopping List test (ISLT) was used to select appropriate patients for the global Phase 3 MissionAD studies investigating the BACE inhibitor elenbecestat. More than 8,000 adults were screened for entry, and the research team fully enrolled their trials. Data showed the ability of the ISLT to confirm a clinically important memory impairment. (Albala, et al, CTAD 2017)

Pivotal Ph 3 Safety Evaluation and Regulatory Approval

Four Cogstate tests were selected as safety outcomes for a pivotal, international Phase 3 pediatric trial of repatha, a drug to address hypercholesteremia. Cholesterol is important for the brain, so it was necessary to show the scientific community and regulators that the drug did not cause any problem with thinking. Data demonstrated that the drug reduced cholesterol levels and is safe in its effect on the brain. The FDA approved the drug for children aged 10+. (R.D. Santos et al., NEJM: DOI 10.1056/NEJMoa2019910)

Support for Proof-of-Concept Evidence Generation in Phase 2 Studies Exploring Cognition

Cogstate digital tests have been used in multiple clinical trials to demonstrate Proof of Concept (POC) and generate efficacy data and support go/no-go decisions in relation to cognition.  

  • Cogstate digital tests were used as exploratory efficacy endpoints in a Ph 2 study of PQ912 in Alzheimer’s disease. Data indicated a treatment-related improvement in working memory, helping guide the team into future study questions and considerations regarding the impact of PQ912.  (Scheltens et al. Alzheimer’s Research & Therapy (2018) 10:107)
  • A phase 2 study of Encenicline for Cognitive Impairment Associated with Schizophrenia (CIAS) was designed to assess and characterize treatment effect on cognition. A Cogstate digital battery was selected as the primary efficacy endpoint. Notable improvements in cognition were demonstrated for treatment vs placebo. (Keefe et al Neuropsychopharmacology (2015) 40, 3053-3060.)
  • A paper in Drug Discovery Today—co-authored by two Cogstate scientists—noted how cognitive data can be used for better Go/No-Go decision-making in Alzheimer’s clinical trials and explored how to apply robust decision-making criteria depending on the specific stage of development, mechanism of action, and design of the trial. Read more.

Academic Research Teams  

Cogstate Research™ is provided at a discounted rate to scientists and institutions conducting eligible research studies. This reflects the value that Cogstate places upon participating in ongoing scientific research. 

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Explore Our Digital Cognitive Tests

Cogstate digital testseach designed to measure a specific area of cognitionare typically grouped together to form customized batteries based on the unique requirements of your study design and population. Explore the details and demos below. (For information on our pediatric versions, please contact our team.)

Behavioral Pattern Separation Object Test (BPSO) Memory

“Indoor or Outdoor”

The Behavioral Pattern Separation Object Test measures recognition memory using photos of objects. The participant is presented with a series of photos of common objects and must decide whether each object is used indoors or outdoors. The participant is then presented with a photo of an object and must recall whether the object is the same, similar or different to the photos they have already been shown.

Cognitive Domain:
Memory

Administration Time:
4 Minutes (for healthy participants)

Outcome Measures:
BPSO Metric, which is the probability of a “Similar” response to a “Distractor” minus the probability of a “Similar” response to a “Foil”.

Continuous Paired Associate Learning Test (CPAL) Paired Associate Learning

“In what locations do these pictures belong?”

The Continuous Paired Associate Learning Test measures visual memory using a paired associative learning paradigm. In this test, the participant must learn and remember the pictures hidden beneath different locations on the screen. In the first stage of the test the pre-test on-screen instructions ask: “In what locations do these pictures belong”. A picture is presented in the centre of the screen. The participant taps the peripheral location of the picture and must remember its location. During the second stage of the test the same pictures are presented in the centre of the screen, however the peripheral location of each picture is hidden. The participant must tap on the peripheral location where the picture previously appeared.

The Continuous Paired Associate Learning Test is also available in a “Delayed Recall” version, which measures memory.

Cognitive Domain:
Paired Associate Learning

Administration Time:
7 Minutes (for healthy participants)

Outcome Measures:
Total number of errors across the seven rounds in the test.

Detection Test (DET) Psychomotor Function

“Has the card turned over?”

The Detection Test measures processing speed using a simple reaction time paradigm. The on-screen instructions ask: “Has the card turned over?”. A playing card is presented face down in the center of the screen. The card flips over so it is face up. As soon as the card flips over the participant must press “Yes”. The participant is encouraged to work as quickly as they can and be as accurate as possible.

Cognitive Domain:
Psychomotor Function

Administration Time:
3 Minutes (for healthy participants)

Outcome Measures:
Speed of performance (mean of the log10 transformed reaction times for correct responses).

Face Name Associative Memory Exam (FNAME) Memory

“Can you remember the Face-Name pair?”

The Face Name Associative Memory Exam measures associative memory using photos of real-life faces. The participant is presented with a series of facial photos and names, with each face paired with a name. The participant must remember the face-name pair.

Cognitive Domain:
Memory

Administration Time:
4 Minutes (for healthy participants)

Outcome Measures:
Total number of correct responses made during each individual sub-test.

Finger Tapping Test Upper Limb Motor Function

“Tap the circle as quickly as you can”

The Finger Tapping Test is a test of upper limb motor function that provides a measure of the speed at which a subject can repeatedly tap a target on the screen for a predefined time period. The test is designed to be administered on a touchscreen device. The subject is asked to use their index finger to tap a stationary target presented on screen as many times as they can until each round ends, with each round alternating between using the right hand and left hand. Performance is measured by calculating the total number of taps on the target during each round. Outcomes are computed for each individual round, rounds for each hand, and all rounds combined.

Domain:
Upper Limb Motor Function

Administration Time:
2 Minutes

Outcome Measures:
Performance is measured by calculating the total number of taps on the target during each round.

Groton Maze Learning Test (GMLT) Executive Function

“Find the hidden pathway”

The Groton Maze Learning Test measures executive function using a maze learning paradigm. A 10 x 10 grid of tiles is presented to the participant on the screen. A 28-step pathway is hidden among these tiles. A blue tile indicates the start and a tile with red circles indicates the finish. The participant must move one step at a time from the start toward the end by touching a tile next to their current location. If the correct move is made a green checkmark appears and if the move is incorrect a red cross is revealed. Once completed, they are returned to the start location to repeat the test and must try to remember the pathway they have just completed.

The Groton Maze Learning Test is also available in a “Delayed Recall” version, which measures visual memory and a “Delayed Reverse Recall” version, which measures spatial working memory.

Cognitive Domain:
Executive Function

Administration Time:
7 Minutes (for healthy participants)

Outcome Measures:
Total number of errors made in attempting to learn the same hidden pathway on five consecutive trials during a single session.

Identification Test (IDN) Attention

“Is the card red?”

The Identification Test measures attention using a choice reaction time paradigm. The on-screen instructions ask: “Is the card red?”. A playing card is presented face down in the center of the screen. The card flips over so it is face up. As soon as it flips over the participant must decide whether the card is red or not. If it is red the participant should press “Yes”, and if it is not red the participant should press “No”. The participant is encouraged to work as quickly as they can and be as accurate as possible.

Cognitive Domain:
Attention

Administration Time:
3 Minutes (for healthy participants)

Outcome Measures:
Speed of performance (mean of the log10 transformed reaction times for correct responses).

International Daily Symbol Substitution Test - Medicines (IDSST-M) Processing Speed

“Select the matching medicine for the date”

The International Daily Symbol Substitution Test – Medicines is a continuous performance test and a well-validated measure of processing speed. In this test, a key is provided at the top of the screen pairing nine medicines with a date (FEB 1, FEB 2, FEB 3, FEB 4, FEB 5, FEB 6, FEB 7, FEB 8 and FEB 9). Each medicine has a unique shape and color and corresponds to a different date (e.g., a round red tablet may be allocated to FEB 3). In the middle of the screen, an empty pill box labelled with a date is presented and the subject is asked to select the medicine that corresponds to that date, as per the key at the top of the screen (e.g., if FEB 3 is the label on the empty box in the middle of the screen, the subject should select the red tablet). The four previous and four upcoming trials are also displayed either side of the current trial. The software records each selection as a correct or incorrect response, and once a response is made it cannot be changed. The medicines are randomly selected from a repository of 100 stimuli, therefore multiple administrations with new date/medicine pairs are possible.

Cognitive Domain:
Processing Speed

Administration Time:
3 Minutes

Outcome Measures:
Total number of correct responses in matching the medicines with the appropriate dates.

International Digit Symbol Substitution Test - Symbols (IDSST-S) Processing Speed

“Select the matching symbol for the number”

The International Digit Symbol Substitution Test – Symbols is a processing speed test that is based on the well-established digit symbol coding paradigm. In this test, subjects are presented with a legend that defines nine symbols, with each symbol corresponding to a digit from 1 to 9. The subject is then presented with a conveyer belt in the middle of the screen that displays a series of empty boxes labelled with a number. The subject must select the symbol that corresponds to the number of a given highlighted box from symbol options presented at the bottom of the screen. The subject must try to place as many correct symbols in the boxes as possible over the duration of the test.

Cognitive Domain:
Processing Speed

Administration Time:
3 Minutes

Outcome Measures:
Total number of correct responses in matching the symbols with the appropriate digits.

International Shopping List Test (ISLT) Verbal Learning

“Tell me as many of the items on the shopping list as you can remember?”

The International Shopping List Test measures verbal learning using a word list learning paradigm. The participant is read a shopping list and must remember and recall as many items from the list as possible.

The International Shopping List Test is also available in a “Delayed Recall” version, which measures verbal memory and a “Recognition” version, which measures memory.

For the International Shopping List Test, the tablet is held by the test administrator and the screen is not visible to the test participant.

Cognitive Domain:
Verbal Learning

Administration Time:
5 Minutes (for healthy participants)

Outcome Measures:
Total number of correct responses made in remembering the list on three consecutive trials at a single session.

One Back Test (ONB) Working Memory

“Is the previous card the same?”

The One Back Test measures working memory using an n-back paradigm. The on-screen instructions ask: “Is the previous card the same?”. A playing card is presented face up in the center of the screen. The participant must decide whether the card is the same as the previous card. If the card is the same the participant should press “Yes”, and if it is not the same the participant should press “No”. The participant is encouraged to work as quickly as they can and be as accurate as possible.

Cognitive Domain:
Working Memory

Administration Time:
4 Minutes (for healthy participants)

Outcome Measures:
Speed of performance (mean of the log10 transformed reaction times for correct responses); Accuracy of performance (arcsine transformation of the square root of the proportion of correct responses).

One Card Learning Test (OCL) Visual Learning

“Have you seen this card before?”

The One Card Learning Test measures visual memory using a pattern separation paradigm. The on-screen instructions ask: “Have you seen this card before in this test?”. A playing card is presented face up in the center of the screen and the participant must decide whether they have seen the card before in this test. The participant is encouraged to work as quickly as they can and be as accurate as possible.

Cognitive Domain:
Visual Learning

Administration Time:
6 Minutes (for healthy participants)

Outcome Measures:
Accuracy of performance (arcsine transformation of the square root of the proportion of correct responses).

Psychomotor Vigilance Test (PVT) Sustained or Vigilant Attention

“Has the yellow counter appeared?” 

The purpose of the traditional Psychomotor Vigilance Test (PVT), a widely used measure of sustained or vigilant attention, is to provide a numerical measure of sleepiness by counting the number of lapses in the attention of the tested subject associated with fatigue caused by both sleep loss or time on task. The Cogstate digital version of the PVT is modeled off the traditional 10-minute version and requires the subject to press a button as soon as they see a yellow timer (the stimuli) appear within a red rectangle.

Cognitive Domain:
Sustained or Vigilant Attention

Administration Time:
10 Minutes (for healthy participants)

Outcome Measures:
Total Lapses, Response Speed

Social-Emotional Cognition Test (SECT) Emotional Recognition

“Tap the odd one out”

The Social-Emotional Cognition Test measures emotional recognition using an odd-man out paradigm. The on-screen instructions ask: “Tap the odd one out”. Four pictures are presented on the screen. One of these pictures will be different to the others and the participant must decide which picture is different and tap that picture. The participant is encouraged to work as quickly as they can and be as accurate as possible.

Cognitive Domain:
Emotional Recognition

Administration Time:
6 Minutes (for healthy participants)

Outcome Measures:
Accuracy of performance (arcsine transformation of the square root of the proportion of correct responses).

Sustained Attention Test (SAT) Sustained Attention

“Has the grey square appeared on the screen?”

The Sustained Attention Test is a measure of sustained attention that uses a signal detection paradigm. The subject indicates whether a small grey square has been presented on screen. The subject responds by pressing the Yes key when the grey square has been presented and No when it is not presented. A distractor condition (dSAT) is present in certain rounds, where the screen background flashes at a rapid rate and thereby makes it more difficult to determine whether the grey square has been presented.

Cognitive Domain:
Sustained Attention

Administration Time:
11 Minutes

Outcome Measures:
The primary outcome measure on this test is the SAT Score. This is a custom outcome that provides a measure of performance accuracy across both signal and non-signal trials.

Sustained Attention to Response Test (SART) Sustained Attention

“Respond to all numbers except 3”

The Sustained Attention to Response Test provides a measure of vigilance and sustained attention. A number ranging from 1 to 9 is presented on screen. The subject must make a response as soon as the number is presented, except when the number is a 3. The number 3 is the default number (no-go stimulus) for which a response should be inhibited, and the subject should not press the predetermined button. The no-go stimulus can be configured to be a number other than 3. Performance is measured by calculating the number of errors made during the test over the course of 225 trials. Performance is measured by calculating the error score, which is the sum of trials where a response was provided when a 3 was presented and trials where no response was provided when a number other than 3 was presented.

Cognitive Domain:
Sustained Attention

Administration Time:
5 minutes 30 seconds

Outcome Measures:
Legal errors

Two Back Test (TWB) Working Memory

“Is the card the same as that shown two cards ago?”

The Two Back Test measures working memory using an n-back paradigm. The on-screen instructions ask: “Is the card the same as that shown two cards ago?”. A playing card is presented face up in the center of the screen. The participant must decide whether the card is the same as the card shown two cards previously. If the card is the same the participant should press “Yes”, and if it is not the same the participant should press “No”. The participant is encouraged to work as quickly as they can and be as accurate as possible.

Cognitive Domain:
Working Memory

Administration Time:
4 Minutes (for healthy participants)

Outcome Measures:
Accuracy of performance (arcsine transformation of the square root of the proportion of correct responses).

Regulatory Compliant

The Cogstate® system meets all relevant regulatory requirements for security and integrity of data in clinical trials, including 21 CFR Part 11. The support procedures meet GCP guidelines.

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