in touch

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PRODUCT OVERVIEW

Cognitive testing software and services for pharmaceutical clinical

trials from Cambridge Cognition Ltd

All trademarks used in this presentation are acknowledged as trademarks or registered trademarks of their respective holders.
 OUTLINE

• Background
• Quality and Regulatory Compliance
• Hardware
• Overview of Subject Data Entry
• Tests
• Data Processing and Checking
• Support
 CANTABelect BACKGROUND

• CANTAB® – acronym for the Cambridge Neuropsychological Test

Automated Battery.
• Created by ProfessorTrevor Robbins & Professor Barbara
Sahakian at Cambridge University in the 1980’s.
• Designed to draw on preclinical principles and to be non-verbal.
• Most widely used computerised battery in the world - 50 countries,
more than 500 research institutes, and appears in over 600 peer
reviewed publications.
 CANTAB FOR CLINICAL TRIALS

• CANTAB® now consists of 23 tests of cognition, owned by

Cambridge Cognition Ltd who provide the software to the
academic, clinical and pharmaceutical industries.
• CANTABelectTM is a regulatory-compliant version of the original
CANTAB software, designed to facilitate your trial’s compliance
with FDA and other regulatory requirements.
• CANTABelect is fully customisable. We work with clients to
configure a battery that is sensitive to the compound or biomarker
in question.
 CANTAB & QUALITY

• Cambridge Cognition’s Quality Management system received

ISO9001:2000 and TickIT accreditation in 2006, to which we
strictly adhere.
• The QMS is primarily aimed at maintaining customer satisfaction
at all stages of our operations. It allows us to support our clients in
meeting regulatory, GCP and industry standard requirements.
• Cambridge Cognition’s commitment to quality extends throughout
the company, its personnel, products and services.
 QUALITY & REGULATORY COMPLIANCE

• All our processes and procedures, from initial user requirement

specifications through to software validation and delivery, are
strictly controlled and regularly reviewed.
• Cambridge Cognition has been, and continues to be successfully
audited by its clients on a regular basis. We welcome audits from
prospective and current clients alike.
• For more information on our QMS, issues relating to regulatory
compliance, or to request an audit please contact our Quality
Manager by email quality@cantab.com or telephone +44 (0)1223
810700
 CANTABelect HARDWARE

• CANTABelect runs on a tablet PC which rests on a stand.

• A press pad is connected for response time measurement.
• Each machine comes with a licence key which also has a built-in
clock for time stamping.
 CANTABelect DATA COLLECTION SCREENS

• When CANTABelect is started, the first interface is a log in screen

– this prevents unauthorised use.
 ACCESS ACCOUNTS

• Administrators – can add and remove users, change their

passwords etc. (the administrator password is provided in a sealed
envelope) but cannot conduct testing.
• One administrator per site. CRAs/Monitors often assume this role.
• Users – can conduct testing and will set their own passwords.
CANTAB trained investigators and site raters/staff assume this
role.
 ADDING/REMOVING USERS

• Administrators can add and remove users as required.

 PASSWORD SECURITY

• All trained users set their own passwords, which must be changed
regularly, to further ensure access security.
 SETTING TIME ZONE

• CANTABelect ensures that correct time-stamping occurs by

requiring the user to set the correct time and date for the
country that he/she is in.
 ENTERING SITE NUMBER

• The research team can choose the parameters of their site numbers
– CANTABelect will issue a warning if the number seems
incorrect. Error checking functions are built-in.
 SUBJECT NUMBERS

• The ranges and nature of subject parameters can also be defined.

CANTABelect will issue warnings if errors are detected and can
even prevent the rater from continuing.
 VISIT SCHEDULES

• Clients can choose their visit schedules, so that sites have a limited
number of options to choose from.
 VISIT SCHEDULE ENFORCEMENT

• If the wrong visit is chosen, CANTABelect will detect this and

issue a warning. This is vital to ensure subjects get the correct
battery of tests in a repeated measures design.
 SUBJECT DETAILS COLLECTION

• Birth dates falling outside your inclusion criteria can be disallowed.

• The fields on this screen are fully customisable – for example, you could
have Subject Number, Gender, and Subject Group.
 CANTABelect TESTS
The battery can then include a combination of the following tests:
Motor Familiarisation Screens for visual, movement
(MOT) and comprehension difficulties
Affective Go/No-go Assesses information
(AGN) processing biases for positive
and negative stimuli
Big/Little Circle Tests comprehension, learning
(BLC) and reversal
Cambridge Gambling Assesses impulse control and
Task (CGT) risk-taking in decision making
Choice Reaction Time Measures speed of choice
(CRT) response
Delayed Matching to Assesses immediate and
Sample (DMS) delayed perceptual matching
Graded Naming Test Gives a measure of semantic
(GNT) memory by assessing object-
naming memory
Intra-Extra Tests rule acquisition, problem
Dimensional Set solving, and attentional set
Shifting (IED) shifting
Matching to Sample Ability to match visual samples
Visual Search (MTS) & measures reaction time
Paired Associates Assesses episodic memory and
Learning (PAL) learning rate
Pattern Recognition Tests visual recognition
Memory (PRM) memory for patterns
Reaction Time (RTI) Measures speed of response
Rapid Visual Tests visual sustained
Information Processing attention
(RVP)
Stockings of Cambridge Assesses spatial planning and
(SOC) motor control
Spatial Recognition Tests recognition memory for
Memory (SRM) spatial locations
Simple Reaction Time Measures speed of response
(SRT) to a single stimulus
Spatial Span (SSP) Assesses working memory
capacity
Spatial Working Memory Tests working memory and
(SWM) strategy use
Verbal Recognition Assesses immediate free
Memory (VRM) recall, and immediate and
delayed recognition memory
Information Sampling Tests impulsivity and decision
Task (IST) making – NEW
One Touch Stockings of Assesses spatial planning -
Cambridge (OTS) NEW
Stop Signal Task (SST) Gives a measure of response
inhibition – NEW
Emotion Recognition Assesses ability to identify
Task (ERT) emotions from facial
expressions -NEW
 ADVICE ON BATTERY SELECTION

• We can advise on how to best customise CANTABelect using tests

that have been validated with existing compounds, such as:

Modafinil Rosiglitazone Acetylcholinesterase Inhibitors

Methylphenidate Chlorpromazine Fluoxetine Tacrine
L-Dopa Tetrahydroaminoacridine Idazoxan
Tryptophan Nicotine Diazepam Clonidine
Haloperidol Scopolamine Gingko-Biloba Sulpiride
Caffeine Tyrosine Bromocriptine Hydrocortisone
• A typical battery might include Spatial Working Memory, Paired
Associates Learning, Reaction Time, Pattern Recognition
Memory, Rapid Visual Information Processing, and Spatial Span,
as in the subsequent slides:
 SPATIAL WORKING MEMORY

• Spatial Working Memory – assesses heuristic strategy and ‘online’

memory, or working memory capacity.
 PAIRED ASSOCIATES LEARNING

• Paired Associates Learning – assesses visual memory and new

learning; sensitive to AD and MCI
 FIVE CHOICE REACTION TIME

• Five Choice Reaction Time – sensitive to sedation and problems in

attention and processing speed. Ideal for safety evaluations.
 PATTERN RECOGNITION MEMORY

• Pattern Recognition Memory – another episodic memory test that

relies on cued memory functions.
 RAPID VISUAL INFORMATION PROCESSING

• Rapid Visual Information Processing – A sustained vigilance test

which can be used in adults and paediatrics.
 SPATIAL SPAN

• Spatial Span – visuospatial memory for sequences

 END OF ASSESSMENT

• We encourage users to make notes about any atypical events –

ensuring that any queries found later can be resolved.
 DATA PROCESSING AND CHECKING

• Data received by Cambridge Cognition is processed and checked

for errors and omissions in line with your bespoke Data
Management Plan. Signed Data Clarification Forms allow the PI
(Principal Investigator) to approve all necessary corrections.
These are then entered into our data management software, which
records an audit log of changes.
 A BESPOKE SERVICE FOR CLINICAL TRIALS

• CANTABelect is a bespoke service for pharmaceutical clinical

trials
• CANTABelect is fully customisable to meet your needs
• This includes, but is not limited to:
• Input formats e.g., date, text and language
• On screen instructions
• Integration of pencil and paper tests into the schedule
• Altered or parallel versions of the tests
• Advice from our Neuropsychology team to help you define the
battery and testing procedure that is best for you
 24/7 SUPPORT FOR YOUR TRIAL

• Every CANTABelect trial has a dedicated project manager and a

24-hour helpdesk number.
• For further information about CANTABelect:
• email us at info@cantab.com
• visit us at www.cantab.com
• phone us on +44(0)1223 810700