TY  - JOUR
PY  - 2016//
TI  - Developing a cognition endpoint for traumatic brain injury clinical trials
JO  - Journal of neurotrauma
A1  - Silverberg, Noah D.
A1  - Crane, Paul K.
A1  - Dams-O'connor, Kristen
A1  - Holdnack, Jim
A1  - Ivins, Brian J.
A1  - Lange, Rael T.
A1  - Manley, Geoffrey T.
A1  - McCrea, Michael
A1  - Iverson, Grant L.
SP  - 363
EP  - 371
VL  - 34
IS  - 2
N2  - Cognitive impairment is a core clinical feature of traumatic brain injury (TBI). Following TBI, cognition is a key determinant of post-injury productivity, outcome, and quality of life. As a final common pathway of diverse molecular and microstructural TBI mechanisms, cognition is an ideal endpoint in clinical trials involving many candidate drugs and non-pharmacological interventions. Cognition can be reliably measured with performance-based neuropsychological tests that have greater granularity than crude rating scales, such as the Glasgow Outcome Scale-Extended, which remain the standard for clinical trials. Remarkably, however, there is no well-defined, widely accepted, and validated cognition endpoint for TBI clinical trials. A single cognition endpoint that has excellent measurement precision across a wide functional range, and is sensitive to the detection of small improvements (and declines) in cognitive functioning, would enhance the power and precision of TBI clinical trials and accelerate drug development research. In this article, we outline methodologies for deriving a cognition composite score and a research program for validation. Finally, we discuss regulatory issues and the limitations of a cognition endpoint.<p />  <p>Language: en</p>
LA  - en
SN  - 0897-7151
UR  - http://dx.doi.org/10.1089/neu.2016.4443
ID  - ref1
ER  -