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DURHAM, NC, United States

Croall I.D.,Newcastle University | Cowie C.J.A.,Newcastle University | He J.,Biomedical Imaging Center | Peel A.,Durham University | And 8 more authors.
Neurology | Year: 2014

Objective: To relate neurophysiologic changes after mild/moderate traumatic brain injury to cognitive deficit in a longitudinal diffusion tensor imaging investigation. Methods: Fifty-three patients were scanned an average of 6 days postinjury (range 5 1-14 days). Twenty-three patients were rescanned 1 year later. Thirty-three matched control subjects were recruited. At the time of scanning, participants completed cognitive testing. Tract-Based Spatial Statistics was used to conduct voxel-wise analysis on diffusion changes and to explore regressions between diffusion metrics and cognitive performance. Results: Acutely, increased axial diffusivity drove a fractional anisotropy (FA) increase, while decreased radial diffusivity drove a negative regression between FA and Verbal Letter Fluency across widespread white matter regions, but particularly in the ascending fibers of the corpus callosum. Raised FA is hypothesized to be caused by astrogliosis and compaction of axonal neurofilament, which would also affect cognitive functioning. Chronically, FA was decreased, suggesting myelin sheath disintegration, but still regressed negatively with Verbal Letter Fluency in the anterior forceps. Conclusions: Acute mild/moderate traumatic brain injury is characterized by increased tissue FA, which represents a clear neurobiological link between cognitive dysfunction and white matter injury after mild/moderate injury. © 2014 American Academy of Neurology. Source

Greer E.M.,City University of New York | Tolmachova M.,Neurocog Trials, Inc.
Helvetica Chimica Acta | Year: 2011

Marie Skłodowska-Curie, the first woman to win a Nobel Prize and the only person to be awarded the Nobel Prize twice in different scientific disciplines, is an inspiring figure. She discovered two new elements, polonium and radium, and was appointed as the first female professor at the University of Paris, when in most countries women did not yet have the right to vote. She serves as a role model for scholarly and humanitarian endeavors through what she attained in science, and through the hardships she had to overcome and the gender discrimination barriers faced by women scientists of that period, which she had to break. This article is a tribute to Marie Skłodowska-Curie's achievements. Copyright © 2011 Verlag Helvetica Chimica Acta AG, Zürich, Switzerland. Source

Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 137.18K | Year: 2009

DESCRIPTION (provided by applicant): An indication for the improvement of cognition in patients with schizophrenia is likely to require demonstration not only of improvement on cognitive tests, but also demonstration that these cognitive changes are clinically meaningful (Buchanan et al., 2005). Real-world functional change is considered to be too high a threshold for registration since outcomes such as employment, independent living, and social relationships are likely to require more time to change than the duration of a typical clinical trial. Further, real-world functional change appears to be dependent upon a variety of circumstances unrelated to treatment, such as whether a patient is receiving disability payments (Rosenheck et al, 2005). For these reasons, FDA representatives have stated that the meaningfulness of cognitive change can be demonstrated with the use of co-primary measures such as tests of functional capacity. However, there are no standard measures of functional capacity. In fact, the recent MATRICS Project concluded that while some available measures held promise as co-primary measures, there were not sufficient data to support the recommendation of any single instrument, and that all currently available instruments had considerable weaknesses (Green et al, in press). Therefore, we propose an SBIR project devoted to the development and validation of computer-based, virtual-reality measures of functional capacity that would be used as co-primary measures in clinical trials of cognitive enhancement in schizophrenia. These measures will assess cognitive function using realistic environments that simulate daily activities. Examples of these activities are presented in the scenario described within the document, along with the respective domains of cognitive function. Measures of cognitive function will be primarily based on error rates and times to completion for each of the assessment activities. All data regarding cognitive scores will be transferred to a central Web server, using standards compliant with both HIPAA and FDA regulations. A library with different scenarios and difficulty levels will be available so that learning effects as well as ceiling and floor effects are diminished. Finally, the measure will be culturally sensitive, allowing for use not only with minority subjects in the United States whose first language is not English, but also with study subjects from other countries participating in international trials. PUBLIC HEALTH RELEVANCE: Schizophrenia is characterized by a diverse array of symptoms, including cognitive deficits which usually accompany (Saykin et al. 1994) or precede (Fuller et al. 2002; Hawkins et al. 2004) the onset of psychosis, and remain throughout the course of illness (Green and Braff 2001; Heinrichs and Zakzanis 1998; Bilder et al. 2000). Unfortunately, while current antipsychotic treatments control the delusions and hallucinations found in people with schizophrenia, these drugs are unable to provide more than minimal cognitive benefit (Harvey and Keefe 2001; Keefe et al. 1999; Woodward et al. 2005; Keefe et al. 2007). A computerized interactive assessment of functional skills, as proposed here, promises to provide pharmaceutical companies with better information regarding patients' real-world functioning so that compounds targeting this improvement can be developed.

Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 711.25K | Year: 2016

DESCRIPTION provided by applicant Aging populations have become a key target for therapeutics developers particularly for indications impacting cognitive function Conditions such as Alzheimerandapos s disease and vascular dementia affect the quality of life of aging Americans largely due to their impact on cognitive function with insufficient therapeutic options Recent reports indicate that early identification of at risk individuals may help to slow progression and onset of cognitive decline Thus new cognitive tests capable of screening patients for mild or moderate cognitive decline associated with the earliest stages of neurodegenerative disease are urgently needed Tests such as the ADAS Cog Alzheimerandapos s Disease Assessment Scale Cognitive subscale lack sensitivity to milder forms of cognitive impairment and are cumbersome and time consuming to administer and score Effective screening tests for cognitive impairment must be brief simple to administer and automatically scored These tests must be tailored toward aging populations and demonstrate sensitivity to mild cognitive decline In order to allow meaningful interpretation of individualandapos s performance well powered demographically targeted normative studies are essential andquot Pen and paperandquot testing remains largely the standard for the assessment of cognitive decline Some recently developed computerized tests have demonstrated improvement in ease of use data reliability and cost effectiveness in most demographic groups In the aging population however performance on computerized tests is often poorly correlated with performance on pen and paper tests calling into question the validity of data collected with computerized tests in this population The Brief Assessment of Cognition BAC test battery developed by NeuroCog Trials has been employed in a range of studies associated with cognitive impairment and has recently been adapted as a computerized test the BAC App administered via iPad r In our company funded andquot Phase I Report andquot we provide details regarding the development of the BAC App as well as data from our validation study showing a strong correlation between performance on the pen and paper BAC and performance on the BAC App in aging adults These data are extremely encouraging and we propose to expand the number of tests included in the BAC App This would allow for greater sensitivity to deficits in episodic memory and spatial working memory which are among the earliest signs of cognitive decline particularly in Alzheimerandapos s Our Phase II program will focus on integrating these new tests into the BAC App conducting a well powered normative data study in aging adults in collaboration with Dr Kathleen Welsh Bohmer Duke University and determining the ability of the BAC App to discern healthy subjects from those experiencing cognitive decline Successful completion of the Phase II program will enable NeuroCog Trials to offer the BAC App in cognitive decline studies specific to aging populations a need reflected in both the literature and recent feedback from NeuroCogandapos s customers PUBLIC HEALTH RELEVANCE As the United States population ages more therapies are being developed and marketed to address cognitive decline particularly for neurodegenerative indications such as Alzheimerandapos s disease A key element to the development of these therapies is reliable assessment of cognition in aging adults Computerizing cognitive tests represents an excellent means to improve cost effectiveness and ease of use However several studies indicate that aging adultsandapos performance on computerized cognitive tests may not always correlate well with their performance on pen and paper cognitive tests To address this urgent and unmet need NeuroCog Trials proposes the tailoring of the Brief Assessment of Cognition Application BAC App a neurocognitive assessment administered via iPad r to aging adult populations for assessment of cognitive deficits

Keefe R.S.E.,Neurocog Trials, Inc. | Davis V.G.,Neurocog Trials, Inc. | Atkins A.S.,Neurocog Trials, Inc. | Vaughan A.,Neurocog Trials, Inc. | And 3 more authors.
Schizophrenia Research | Year: 2016

Regulatory guidance for schizophrenia cognition clinical trials requires that the assessment of cognitive change is accompanied by a functionally meaningful endpoint. However, currently available measures are challenged by resistance to change, psychometric weaknesses, and for interview-based assessments, dependence upon the presence of an informant. The aims of the current study were to: 1) assess the validity, sensitivity, and reliability of the Virtual Reality Functional Capacity Assessment Tool (VRFCAT) as a measure of functional capacity; 2) determine the association between performance on the VRFCAT and performance on the MATRICS Consensus Cognitive Battery (MCCB); and 3) compare the metrics of the VRFCAT with the UCSD Performance-based Skills Assessment (UPSA). 167 patients with schizophrenia and 166 healthy controls completed the VRFCAT, UPSA, and the MCCB at baseline. The VRFCAT and UPSA were completed again at follow-up. The VRFCAT, MCCB, and UPSA were very sensitive to impairment in schizophrenia (d = 1.16 to 1.22). High test-retest reliability was demonstrated for VRFCAT total completion time and the UPSA total score in patients (ICC = 0.81 and 0.78, respectively). The UPSA demonstrated significant practice effects in patients (d = 0.35), while the VRFCAT did not (d = -0.04). VRFCAT total completion time was correlated with both UPSA (r = -0.56, p <. 0.0001 for patients and -0.58, p <. 0.0001 for controls) and MCCB Composite (r = -0.57, p <. 0.0001 for patients and -0.68, p <. 0.0001 for controls). The VRFCAT is a highly reliable and sensitive measure of functional capacity with associations to the UPSA and MCCB. These results provide encouraging support for a computerized functional capacity assessment for use in schizophrenia. © 2016 The Authors. Source

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