Scientific Milestones
NeuroCog Trials was built around Dr. Keefe’s imperative to bring to industry the same precision, accuracy and data quality requisite to his academic work. His vision began as an outgrowth of the many studies undertaken at his Duke University lab and continues to evolve through his work there and among collaborators at some of the most respected academic settings in the country. Dr. Keefe and his academic collaborators have played key roles in a number of prominent multi-site neurocognition studies funded by federal government agencies.
CATIE Project (Clinical Antipsychotic Trials for Intervention Effectiveness)
The CATIE Project is the largest contract ever awarded by the National Institute of Mental Health. Dr. Keefe was the CATIE Neurocognitive Assessment Unit Director. The $42.6 million study was conducted over a five-year period at 57 clinical sites across the country. Over 1,400 patients were evaluated, at the time, an unprecedented number.
For the CATIE Project, our affiliated laboratory at Duke was selected to:
- Train and certify over 250 raters
- Oversee the assessment of 2,000 patients in the schizophrenia and dementia trials of the project
- Assure data quality for the neurocognitive measures, including 12 pencil-and-paper tests and 3 computerized test
For more information:
Arch Gen Psychiatry. 2007 Jun;64(6):633-47.
N Engl J Med. 2005 Sep 22;353(12):1209-23.
MATRICS Project (Measurement and Treatment Research In Cognition in Schizophrenia)
The MATRICS Project (www.matricsinc.org), which involved a series of meetings in 2003 and 2004 to discuss methods for assessing and improving neurocognition in patients with schizophrenia, produced agreement among scientists from industry, government and academia on seven cognitive domains for the battery and five criteria for test selection. Dr. Keefe was named a member of the Neurocognition Committee that selected the tests to be considered for the MATRICS battery, and was appointed Principal Investigator at the Duke University site for the 5-site study to determine which test had sufficient statistical and psychometric properties to qualify them for the final MATRICS battery. He was also a member of the FDA-NIMH Panel that outlined suggested methodology for completing cognitive enhancement trials in schizophrenia.
TURNS Project (Treatment Units for Research in Neurocognition in Schizophrenia)
Dr. Keefe is also the Co-director of the Trials Management Unit for TURNS (Treatment Units for Research in Neurocognition in Schizophrenia). The TURNS network is a group of seven highly regarded academic sites (Duke University, UCLA, Harvard, MPRC, Nathan Kline Institute, Columbia and Washington University) selected by NIMH to conduct research in neurocognition in schizophrenia. This network carried out proof-of-concept trials for new compounds designed to enhance neurocognition forwarded by the MATRICS Neurocognition Committee.