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Clinical and Amyloid Screen Failure Rates in Episodic Memory Measures of Early AD Trials

This study examined two episodic memory measures – the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and the Cogstate International Shopping List Test (ISLT) – to compare their clinical and amyloid screen failure rates in early AD trials.

Authors: S. Negash, C. Weber, C. Randolph

Presented at the 11th Clinical Trials on Alzheimer’s Disease (CTAD), Barcelona, Spain (October 2018)

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Independent Telephone-based Assessment of Depressive Symptoms in China

A pilot study conducted at three hospitals in China studied remote independent administration of the Structured Interview Guide for the Montgomery-Asberg Depression Rating Scale (SIGMA) to determine the reliability of the MADRS when administered via telephone to Mandarin-speaking patients in China with Major Depression Disorder.

Authors: Gang WANG, Tianmei SI, Xiufeng XU, Jaskaran SINGH, Jessie HE, Cong LIU, Lawrence H. Yang, Honglan LI, Jianmin ZHUO, Mark Opler

Presented at The International Society for CNS Clinical Trials and Methodology (ISCTM) Autumn Conference, Marina Del Ray, CA (October 2018)

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Error Rates and Data Integrity: eCOA versus Paper Administration of the PANSS

Methodological Question: Does the use of electronic clinical outcomes assessment (eCOA) impact rates of scoring errors as evaluated with the ISCTM working group consensus method for PANSS data?

Among the Conclusions: eCOA administrations of the Positive and Negative Syndrome Scale (PANSS) are less susceptible to scoring inconsistencies and error compared to those administered on paper.

Authors: S. Negash, G. Capodilupo, B. Echevarria, M. Opler

Presented at The International Society for CNS Clinical Trials and Methodology (ISCTM) Autumn Conference, Marina Del Ray, CA (October 2018)

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Independent and Site-based Ratings of Symptom Severity in Pharmacogenetics Clinical Trials

Personalized medicine and pharmacogenomics hold strong promise for psychiatry. Studies in this area require novel approaches to ensure endpoint reliability and validity, reduce the impact of treatment unblinding, and minimize other confounds that reduce signal detection. At the American Psychiatric Association Annual Meeting, MedAvante-ProPhase presented analysis of a combination of novel assessment methods, including remote, independent ratings, to evaluate adherence to inclusion criteria and efficacy in pharmacogenetics clinical trials.

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Reliability Findings from the Unified Global Training Program for the Brief Negative Symptoms Scale (BNSS)

MedAvante-ProPhase presented an analysis of reliability in administration of the Brief Negative Symptoms Scale (BNSS) across multiple studies and countries at the 14th International Society for CNS Clinical Trials and Methodology (ISCTM) Scientific Conference. BNSS achieved overall good-to-excellent inter-rater reliability among raters from different countries and cultures.

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Simplified Negative and Positive Symptoms Interview (SNAPSI): An Abbreviated Assessment Technique for Schizophrenia Studies

Analysis of the methodological question can the PANSS be modified to be useable in clinical settings as well as in research? presented at the 14th ISCTM Scientific Conference. Authors propose PANSS-6 rating, guided by SNAPSI, to bridge the gap between research and clinical care in schizophrenia.

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