CLINICAL TRIALS
Cognition mission
Graduate work conducted three decades ago led to the formation of niche
specialty CRO Cognitive Drug Research and through organic growth the
company is expanding its global reach, US-based vice-president Steve Satek
explains to Caroline Richards
STEVE SATEK
Q.
automated a wide range of standard cognitive
How is Cognitive Drug Research
assessments that are well known to the industry,
different from other CROs?
but initially developed outside of CDR. In total,
CDR offers over 50 computer-based cognitive
Cognitive Drug Research (CDR) is a global
assessments. Unlike many paper-based assessments
specialty niche CRO that provides a full-service
and some competitor systems, CDR’s battery was
offering of computer-based cognitive testing
designed to be employed specifically in clinical trials.
systems. The company assists clients to develop
The system is structured to precisely identify any
new study designs and task selection, trains site staff,
changes in various aspects of cognitive function that
collects study data in real-time, manages study data,
occur over time (hours, days, months or years) as a
provides statistical analyses and produces final
result of drugs or other study interventions. Tasks
reports. A snapshot of the company is given in
are very simple for subjects or patients to
Box 1.
complete. Children as young as six can be tested
Over the past three years, CDR has invested
and there is no upper age limit. Further, the tests
heavily in further improving the programmes and
can be used in a wide variety of patient
databases that make it a market leader in cognitive
populations, as shown in Table 1.
assessment. It has also opened two offices in the
US and Australia, complementing its European
presence in the UK. CDR aims to maintain its pre- Q. Is the system compliant with regulatory
eminence as the world’s leading supplier of
requirements?
automated cognitive tests to the pharmaceutical,
biotech and food product/nutraceutical industries.
The CDR system is GCP compliant and compliant
The CDR System is a standard, proprietary
with the US FDA 21 CFR part 11 requirements.
series (or battery) of nine computer-based tasks
CDR has been successfully audited over 35 times
developed in the mid-1970s as part of the
by biotech and pharmaceutical companies, as well
graduate work conducted by the company’s CEO
as UK regulator the MHRA.
Professor Keith Wesnes. Over the past 30+ years,
the tasks have been extensively-validated and used
in the vast majority of the company’s 1,000+
Q. What types of cognitive processes does
studies. the system test?
In addition to the core proprietary battery, CDR
has developed and validated new supplementary The CDR System measures the key cognitive
tasks to meet client needs and has also computer- domains that are crucial for the conduct of the
Table 1: Therapy areas addressed by the CDR system
Indication Patient groups
dementias age-associated memory impairment (AAMI); age-related cognitive
decline (ARCD); Alzheimer’s disease; dementia with Lewy bodies;
frontal lobe dementia; Huntington’s dementia; mild cognitive
impairment (MCI); Parkinson’s disease dementia; vascular dementia
psychiatry/neurology ADHD; chronic fatigue syndrome; depression; epilepsy; f_i bromyalgia;
head trauma; Huntington’s chorea; insomnia; narcolepsy;
neurasthenia; multiple sclerosis; Parkinson’s disease; restless leg
syndrome; schizophrenia; sleep apnoea; sleep disorders; shift workers
cardiovascular carotid endarterectomy; congestive heart failure; coronary stroke
(+/– hemiparalysis); varicose veins artery bypass graft (CABG);
hypertension
other AIDS/HIV; cancer; diabetes; hepatic encephalopathy; hepatitis C;
hyponatremia; kidney dialysis; kidney transplant; liver transplant;
menopause; nutrition; obesity; orthopaedic surgery; post-operative
recovery; urge incontinence; type 1 Gaucher disease
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