Innovations In Clinical Neuroscience

2015 Abstracts of Poster Presentations

A peer-reviewed, evidence-based journal for clinicians in the field of neuroscience

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[ V O L U M E 1 2 , N U M B E R 1 1 – 1 2 , N O V E M B E R – D E C E M B E R 2 0 1 5 , S U P P L E M E N T C ] Innovations in CLINICAL NEUROSCIENCE 7 variables and subjective sleep quality are significantly higher than for any corresponding set of traditional sleep variables (by 35% on average, r =0.40±0.042 for PSG to r=0.52±0.035 for the PSM). Conclusion: This work confirms that a EEG-based description of human sleep that goes beyond traditional sleep stages can extract more information about sleep and thus constitutes a better biomarker for measuring how well a person slept subjectively. This can be an important tool for early clinical trials on hypnotics. Disclosures: Georg Dorffner is a part-time employee of The Siesta Group GmbH. PATIENT ASSESSMENT, SCALES, AND TOOLS Examining placebo effects on MATRICS battery measures in schizophrenia cognition clinical trials Presenters: 1 , 2 Keefe R, 2 Davis V, 2 Atkins A, 3 Harvey P, 4 Lombardo I, 5 Bugarski-Kirola D, 6 Reid C Affiliations: 1 Duke University; 2 NeuroCog Trials; 3 University of Miami; 4 Axovant Sciences Inc.; 5 F. Hoffmann-La Roche Ltd; 6 Roche Products Limited Background: The Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Battery (MCCB) is described as the gold standard by members of the psychiatry divisions of the US FDA and the European Medicines Agency. Objective: The psychometrics of the MCCB have been increasingly well established. However, the magnitude and predictors of improvement in sequential assessments with placebo treatment is unknown. Methods: We combined data from 12 MCCB studies assessing 753 placebo-treated patients with schizophrenia over 4 to 56 weeks. Change from baseline was investigated using a mixed-effects model of repeated measures. P redictors evaluated included demographics, baseline characteristics and symptoms. Practice effects were examined in a model including seven studies (N=498) that measured cognition at screening. Results: The overall mean change in the MCCB composite over 56 weeks, adjusting for baseline score, study and their interaction, was 1.8±0.20 T-score points. Mean change scores for the 10 subtests comprising the MCCB ranged from 0.2±0.33 (MSCEIT) to 2.3±0.35 (Trail Making) T-score points. Patients with higher baseline PANSS Marder anxiety/depression factor scores were more likely to show improvement on the MCCB composite (p=0.004). Practice effect prior to randomization was negatively associated with placebo response (p<0.001). Conclusions: Improvement on the MCCB under placebo conditions was generally consistent with known practice effects. Results suggest that placebo effects beyond known practice effects are not a major barrier for designing cognitive impairment treatment trials in patients with schizophrenia. Studies with a higher number of assessments are susceptible to greater improvement in the placebo group. The tablet-based Brief Assessment of Cognition (BAC App) for schizophrenia Presenters: 1 , 2 Keefe R, 1 Atkins A, 1 Davis V, 1 Tseng T, 1 Vaughan A, 3 Harvey P, 4 Patterson T, 5 Narasimha M Affiliations: 1 NeuroCog Trials; 2 Duke University Medical Center; 3 University of Miami Miller School of Medicine; 4 University of California, San Diego, School of Medicine; 5 University of South Carolina School of Medicine Background: The Brief Assessment of Cognition in Schizophrenia (BACS) is a pen-and- paper cognitive assessment tool that has been used in hundreds of research studies and clinical trials, and has normative data available for g enerating age- and gender- corrected standardized scores. Objective: A tablet-based version of the BACS called the BAC App has been developed. This study compared performance on the BACS and the BAC App in patients with schizophrenia and healthy controls. Methods: Forty-eight patients with schizophrenia and 50 demographically matched healthy controls from three academic research centers were assessed with the BACS and the BAC App. Results: In both groups, the distributions of standardized composite scores for the tablet-based BAC App and the pen-and-paper BACS were indistinguishable, and the between-methods mean differences were not statistically significant. The discrimination between patients and controls was similarly robust with the BAC App (d=1.34) and the BACS (d=1.24). The between-methods correlations for individual measures in patients were r>0.70 except Token Motor (r=0.43) and Tower of London (r=0.61). In patients, performance between the test methods was not significantly different on any test except the Token Motor Test. When data from the Token Motor Test were removed, the between-methods correlation of composite scores improved to r=0.88 (df=48; P<0.001) in healthy controls and r=0.89 (df=46; P<0.001) in patients, consistent with the test-retest reliability of each measure. Conclusion: The tablet-based BAC App generates results consistent with the traditional pen- and-paper BACS. These data support the notion that the BAC App can now be used in clinical trials and clinical practice. Disclosures: Richard Keefe receives royalties for the BACS and the BAC App and is the owner of NeuroCog Trials, which provides commercial services to support both

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