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News Article | July 13, 2017
Site: www.prnewswire.com

"I am thrilled to be presenting Pathway to the clinical trials community. We have dedicated ourselves to creating a tool that has a beautifully simple user interface, rigorous attention to scientific and regulatory detail, and a seamless back-end data transfer and storage system," said Co-Founder and CEO, Dr. Richard Keefe. Other key benefits of NCT Pathway include: automated features and assisted scoring for improved protocol compliance, real-time data capture, central review portal, CDISC compliant storage and data transfer, and integrated security and regulatory compliance features. Recognized globally for expertise in clinical and cognitive measurement and data quality assurance, NeuroCog Trials implements rigorous testing and validation procedures to proactively anticipate challenges and ensure the highest level of performance across all its software solutions. NCT delivers innovative technology and science-driven data solutions with unrivaled dependability. To learn more about NCT Pathway, please visit http:/www.neurocogtrials.com/products/pathway-ecoa/. NeuroCog Trials (NCT) is a cognition and clinical assessment services and technology company devoted exclusively to applying rigorous standards for key endpoints in multi-site clinical trials in many different indications. It has provided consulting, site screening, rater training and certification, translation, and data services for more than 100 clinical trials in over 25 countries. Founded in 2005, NCT is a privately held, certified woman-owned business, headquartered in Durham, North Carolina.


During his tenure as Director General of AIFA, Dr. Pani pioneered several new approaches to drug approval, pricing and reimbursement strategies by using advanced informatics to follow and certify real-world data. These models are now being used in many other countries. As a European Regulator, Dr. Pani has not only been a leading figure for the Approval and Scientific Advice for Central Nervous System products, but also has served as Chair of the Telematics Committee. While in AIFA Dr. Pani worked on the approvals of pharmaceutical products in a broad range of all therapeutic areas including oncology, immunology, cardiovascular and CNS disorders. "I am privileged to have someone with Dr. Pani's extraordinary background and expertise in regulatory, academic and industry science come to NeuroCog Trials as we expand the breadth of solutions we offer for clinical trial methodologies. Dr. Pani will have an immediate impact and provide deep insight and perspective into our development of innovative strategies for transforming the current landscape," said Co-Founder and CEO, Dr. Richard Keefe. NCT offers clients global and regional study design strategies, protocol advisory and measure selection services as well as technology solutions that maximize opportunities for success by adhering to the highest scientific principles and regulatory standards across all clinical phases.  Dr. Pani's expertise innovating health economics and outcomes research will become a central element of NCT's services. Dr. Pani is the author or co-author of hundreds of publications and is an internationally recognized speaker at scientific meetings and conferences. He is also professor of Psychiatry at the University of Miami. In addition, his most recent book, Sustainable Innovation: Medicines and the Challenges for the Future of our National Health Service has been published to acclaim. He has served on the editorial boards of many prestigious scientific journals including Clinical Neuropsychiatry, Italian Journal of Psychiatry and Psychotherapy, and the Italian Edition of the American Journal of Psychiatry. He received his medical degree from the University of Cagliari, psychiatry degree from the University of Naples and completed post-doctoral training in molecular biology and pharmacology at the University of Illinois and Georgetown University. NeuroCog Trials (NCT) is a global cognition and clinical assessment services and technology company devoted to applying rigorous standards for key endpoints in multi-site clinical trials in many different indications. NCT has provided consulting, site screening, rater training and certification, translation, and data services for more than 100 clinical trials in over 25 countries. Founded in 2005, NCT is a privately held, certified woman-owned business, headquartered in Durham, North Carolina.


Keefe R.S.E.,Duke University | Keefe R.S.E.,Neurocog Trials, Inc. | Davis V.G.,Neurocog Trials, Inc. | Spagnola N.B.,Neurocog Trials, Inc. | And 6 more authors.
European Neuropsychopharmacology | Year: 2015

Cognitive functioning can be assessed with performance-based assessments such as neuropsychological tests and with interview-based assessments. Both assessment methods have the potential to assess whether treatments for schizophrenia improve clinically relevant aspects of cognitive impairment. However, little is known about the reliability, validity and treatment responsiveness of interview-based measures, especially in the context of clinical trials. Data from two studies were utilized to assess these features of the Schizophrenia Cognition Rating Scale (SCoRS). One of the studies was a validation study involving 79 patients with schizophrenia assessed at 3 academic research centers in the US. The other study was a 32-site clinical trial conducted in the US and Europe comparing the effects of encenicline, an alpha-7 nicotine agonist, to placebo in 319 patients with schizophrenia. The SCoRS interviewer ratings demonstrated excellent test-retest reliability in several different circumstances, including those that did not involve treatment (ICC > 0.90), and during treatment (ICC >0.80). SCoRS interviewer ratings were related to cognitive performance as measured by the MCCB (r=-0.35), and demonstrated significant sensitivity to treatment with encenicline compared to placebo (P<.001). These data suggest that the SCoRS has potential as a clinically relevant measure in clinical trials aiming to improve cognition in schizophrenia, and may be useful for clinical practice. The weaknesses of the SCoRS include its reliance on informant information, which is not available for some patients, and reduced validity when patient's self-report is the sole information source. © 2014 Elsevier B.V. and ECNP.


Ruse S.A.,Neurocog Trials, Inc. | Harvey P.D.,University of Miami | Harvey P.D.,Miami Medical Center | Davis V.G.,Neurocog Trials, Inc. | And 4 more authors.
Schizophrenia Research: Cognition | Year: 2014

Introduction: Assessment of functional capacity is an intrinsic part of determining the functional relevance of response to treatment of cognitive impairment in schizophrenia. Existing methods are highly and consistently correlated with performance on neuropsychological tests, but most current assessments of functional capacity are still paper and pencil simulations. We developed a computerized virtual reality assessment that contains all of the components of a shopping trip. Methods: We administered the Virtual Reality Functional Capacity Assessment Tool (VRFCAT) to 54 healthy controls and to 51 people with schizophrenia to test its feasibility. Dependent variables for the VRFCAT included time to completion and errors on 12 objectives and the number of times that an individual failed to complete an objective. The MATRICS Consensus Cognitive Battery (MCCB) and a standard functional capacity measure, the UCSD Performance-Based Skills Assessment-Brief (UPSA-B), were administered to the patients with schizophrenia. Results: Patients with schizophrenia performed more poorly than healthy controls on 10/11 of the time variables, as well as 2/12 error scores and 2/12 failed objectives. Pearson correlations for 7 of 15 VRFCAT variables with MCCB composite scores were statistically significant. Conclusion: These results provide support for the possibility of computerized functional capacity assessment, but more substantial studies are required. © 2014 Elsevier Inc.


Hermes E.,Yale University | Nasrallah H.,University of Cincinnati | Davis V.,Neurocog Trials, Inc. | Meyer J.,University of San Diego | And 8 more authors.
Schizophrenia Research | Year: 2011

Background: Weight gain and changes in metabolic indicators associated with some antipsychotics may be related to symptom improvement and thus an unavoidable correlate of clinical benefit. Methods: Data from the CATIE schizophrenia trial comparing the effectiveness of perphenazine, olanzapine, risperidone, quetiapine and ziprasidone in a randomized, double-blind, trial over 18. months were used to evaluate the relationship between percent change in body mass index (BMI) and change in total serum cholesterol and triglycerides with the Positive and Negative Syndrome Scale (PANSS) score. Analysis of covariance for observations at 3. months and a mixed effects model for all observations up to 18. months adjusted for potentially confounding variables were used to examine these associations. Results: In both models, there was a significant association (p=0.001) between change in PANSS total score and percent change in BMI, equating to a 0.28 and 0.21 point decrease in PANSS total score (range 30-210) per 1% increase in BMI respectively. Change in BMI accounted for 3% or less of variance for change in PANSS scores. There was no evidence that the association of symptoms and weight gain differed across medications in spite of substantial differences in weight gain and other metabolic measures. Neither total serum cholesterol nor triglyceride levels displayed a significant association with change in PANSS. Conclusion: The magnitude of the relationship between change in BMI and PANSS was too small to be clinically important, indicating that switching medications to one with less metabolic risk is unlikely to result in meaningful loss of clinical benefit. © 2011 Elsevier B.V.


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.


Keefe R.S.E.,Duke University | Keefe R.S.E.,Neurocog Trials, Inc. | Fox K.H.,Neurocog Trials, Inc. | Harvey P.D.,University of Miami | And 3 more authors.
Schizophrenia Research | Year: 2011

Objective: The Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Project produced a battery of tests, the MATRICS Consensus Cognitive Battery (MCCB), designed to assess cognitive treatment effects in clinical trials of patients with schizophrenia. In validation studies, the MCCB demonstrated excellent reliability, minimal practice effects and significant correlations with measures of functional capacity. This study addresses whether the MCCB demonstrates these favorable characteristics when administered in the context of the type of large multi-site industry trial for which it was designed. Methods: In a clinical trial comparing risperidone and lurasidone, 323 clinically-stable outpatients with schizophrenia at 29 sites were assessed with MCCB at screening and a median of 15. days later at baseline. A measure of functional capacity, the UCSD Performance-based Skills Assessment - Brief (UPSA-B) was administered at baseline. Results: All 323 (100%) patients had sufficient data for computing a composite score according to the MCCB criteria. The test-retest reliability of the MCCB composite score was excellent (ICC. = 0.88). The severity of cognitive impairment was T = 24.7 (SD. = 12.1) at screening and T = 26.7 (SD. = 12.4) at baseline. The MCCB composite score demonstrated a large correlation with the UPSA-B composite score (r = 60, df = 304, p< .001). The practice effect on the composite score was small (z = 0.18). Discussion: In the context of a 29-site antipsychotic trial in stable outpatients with schizophrenia, the MCCB is sensitive to cognitive deficits in all domains, demonstrates excellent test-retest reliability and small practice effects, and is strongly correlated with a leading measure of functional capacity. © 2010 Elsevier B.V.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 1.15M | Year: 2012

DESCRIPTION (provided by applicant): Schizophrenia is a devastating and costly mental illness with direct and unemployment costs approaching 95 billion per year. Cognitive impairments affect the majority of patients with schizophrenia. These impairments are strongly associated with poor long-term psychosocial outcomes and reflect a large and significant unmet clinical need. FDA approval of new drugs for cognitive impairment in patients with schizophrenia requires pharmaceutical companies to demonstrate notonly improvements on cognitive tests, but also clear evidence that these cognitive changes lead to clinically meaningful improvements in functional capacity. Measures of functional capacity, known as co-primary measures, indicate the degree to which individuals have changed their potential to alter real-world behavior. At present, there are no standard measures of functional capacity, and existing data do not support the recommendation of any single instrument. The Virtual Reality Functional Capacity Assessment Tool (VRFCAT Copyright (c) 2011) is a novel computer based virtual-reality measure of functional capacity that relies on a realistic simulated environment to recreate routine activities of daily living. We designed it initially for use in domestic schizophrenia drug trials and were successful at developing and pilot testing it in the NIMH SBIR Phase 1 project. Findings on VRFCAT's reliability were encouraging and indicated that it may be superior to the most commonly used measure of functional capacity, the UPSA-2. In this Phase 2 SBIR application, we propose to further evaluate and establish the VRFCAT's sensitivity, reliability, validity and practicality, and prepare to commercialize it through NeuroCog Trials' existing sales and operational infrastructure. This application has 5 specific aims: 1) Examine VRFCAT's ability to measure changes in functional capacity by comparing it to the UPSA-2 in patients with schizophrenia and healthy controls; 2) Examine and compare the test-retest reliabilities ofthe VRFCAT and UPSA-2; 3) Determine the association between performance on the VRFCAT and performance on the standard measure of cognition, the MATRICS Consensus Cognitive Battery (MCCB); 4) Examine the relative strength of the relationship of the VRFCAT and the UPSA-2 with a measure of real-world functioning outcomes, the Specific Levels of Functioning (SLOF); 5) Assess the usability and practicality of the VRFCAT for both patients and research staff in multiple clinical trial settings. In Phase 1 we showed the VRFCAT to be a reliable measure. Phase 2 will allow us to further develop and commercialize the VRFCAT. This new and superior measure of functional capacity could improve clinical trials and facilitate approval for drugs to treat cognitive impairmentin patients suffering from schizophrenia. The VRFCAT has the potential to fulfill the FDA's requirement of a reliable co- primary measure, and will help determine which new drugs have a meaningful impact on cognition and on the lives of schizophrenia patients. PUBLIC HEALTH RELEVANCE: Schizophrenia is a serious mental illness that affects approximately three million Americans and costs about 100 billion a year for direct treatment, community services, and lost wages. While the most obvious symptoms such as hallucinations and bizarre beliefs can be minimized with treatment, there is no currently available treatment for the underlying cognitive disturbances such as memory and attention impairment that are the prime cause of functional disability. Because one of the greatest current challenges of drug development in schizophrenia is to find the best tools for measuring changes in cognition and functioning, this research aims to provide the field with a valid measure of changes in functionally relevantcognition.


Grant
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


News Article | November 30, 2016
Site: www.prnewswire.com

DURHAM, N.C., Nov. 30, 2016 /PRNewswire/ -- NeuroCog Trials, the leading cognitive services provider for the clinical trials industry, today announced that it is significantly expanding its presence at its headquarters in Durham. Construction is currently underway to give NeuroCog Trials t...

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