Alan Kott
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View article: Assessing the Performance of Confirmatory Cognitive Tests in Screening Subjects for Early Alzheimer's Disease Clinical Trials
Assessing the Performance of Confirmatory Cognitive Tests in Screening Subjects for Early Alzheimer's Disease Clinical Trials Open
Background In early Alzheimer's Disease clinical trials, confirmatory cognitive tests such as the FCSRT, RBANS and Wechsler Memory Scale (WMS)‐Logical Memory II are often used at Screening to assure that only subjects with objectifiable co…
View article: Identifying Problematic Subjects Entering Clinical Trials in Early Alzheimer’s Disease
Identifying Problematic Subjects Entering Clinical Trials in Early Alzheimer’s Disease Open
Background Our prior retrospective analyses found that a large portion of subjects randomized into early Alzheimer's Disease trials were more severe than required by the protocol. We have identified a number of individual factors that can …
View article: Measurement of schizophrenia symptoms through speech analysis from PANSS interview recordings
Measurement of schizophrenia symptoms through speech analysis from PANSS interview recordings Open
Introduction Speech is considered a clinically meaningful indicator of schizophrenia symptom severity and the quantification of speech measures has the potential to improve the measurement of symptoms. Speech collection for digital phenoty…
View article: Impact of Site Size on Data Quality in Early Alzheimer’s Disease Clinical Trials
Impact of Site Size on Data Quality in Early Alzheimer’s Disease Clinical Trials Open
Background Clinical trial sponsors rely on research sites to identify and enroll appropriate study participants and to correctly and reliably assess symptom severity and function over the course of the trial. Low‐recruiting sites represent…
View article: Impact of Rater Change on MMSE Data. A Post‐Hoc Analysis
Impact of Rater Change on MMSE Data. A Post‐Hoc Analysis Open
Background Rater change is inevitable in often lengthy clinical trials in Alzheimer’s disease. Other groups have previously assessed the impact of rater change on data variability. Their conclusions varied, possibly due to differing method…
View article: Are There Differences in Screening MMSE Interview Durations Between Subjects Who Maintain Severity and Subjects Who Drop Below Screening Inclusionary MMSE Thresholds at Baseline? An Exploratory Analysis.
Are There Differences in Screening MMSE Interview Durations Between Subjects Who Maintain Severity and Subjects Who Drop Below Screening Inclusionary MMSE Thresholds at Baseline? An Exploratory Analysis. Open
Background We have previously identified a large proportion of subjects (> 10%) entering clinical trials in early Alzheimer’s disease to possibly suffer from Baseline inflation (Kott, 2023). Without useful predictive markers, the identific…
View article: Do Subjects Not Meeting Screening Inclusion Criteria at Baseline Differ in Screening Performance in Diagnostic Tests in Early Dementia Clinical Trails?
Do Subjects Not Meeting Screening Inclusion Criteria at Baseline Differ in Screening Performance in Diagnostic Tests in Early Dementia Clinical Trails? Open
Background The success of any clinical trial begins with ensuring that participants entering the trial meet the inclusion criteria and disease severity. Score manipulation to meet eligibility criteria may contribute to loss of signal in cl…
View article: Consistency checks to improve measurement with the Young Mania Rating Scale (YMRS)
Consistency checks to improve measurement with the Young Mania Rating Scale (YMRS) Open
Using established methods, we illustrate development and application of consistency flags for YMRS ratings. Applying flags and mitigation during trials may improve the value of YMRS data, help focus attention on rater training, and improve…
View article: Consistency checks to improve measurement with the Hamilton Rating Scale for Anxiety (HAM-A)
Consistency checks to improve measurement with the Hamilton Rating Scale for Anxiety (HAM-A) Open
Mitigating rating inconsistency can improve measurement fidelity and detection of treatment response. The International Society for CNS Clinical Trials and Methodology convened an expert Working Group that developed consistency checks for …
View article: The Impact of Baseline Anxiety on Drug Placebo Separation and Drug/Placebo Response in an Acute Schizophrenia Clinical Trial—A Post-hoc Analysis
The Impact of Baseline Anxiety on Drug Placebo Separation and Drug/Placebo Response in an Acute Schizophrenia Clinical Trial—A Post-hoc Analysis Open
Objectives We sought to evaluate the impact of baseline anxiety levels on drug placebo separation and drug and placebo response in acutely psychotic schizophrenic subjects. Methods In this post-hoc analysis, modified intent-to-treat Positi…
View article: Remote Assessment of Negative Symptoms of Schizophrenia
Remote Assessment of Negative Symptoms of Schizophrenia Open
In contrast to the validated scales for face-to-face assessment of negative symptoms, no widely accepted tools currently exist for remote monitoring of negative symptoms. Remote assessment of negative symptoms can be broadly divided into 3…
View article: Consistency checks to improve measurement with the Hamilton Rating Scale for Depression (HAM-D)
Consistency checks to improve measurement with the Hamilton Rating Scale for Depression (HAM-D) Open
Application of flags to clinical ratings may aid in detecting imprecise measurement. Reviewing and addressing these flags may improve reliability and validity of clinical trial data.
View article: The Impact of Aberrant Data Variability on Drug–Placebo Separation and Drug/Placebo Response in an Acute Schizophrenia Clinical Trial
The Impact of Aberrant Data Variability on Drug–Placebo Separation and Drug/Placebo Response in an Acute Schizophrenia Clinical Trial Open
Objective In the current posthoc analyses, we evaluated the impact of markers of aberrant data variability on drug placebo separation and placebo and drug response in an acute schizophrenia clinical trial. Methods Positive and negative syn…
View article: The impact of protocol design on MMSE changes in the screening period
The impact of protocol design on MMSE changes in the screening period Open
Background Anecdotally, we have observed subgroups of subjects who in the screening period of clinical trials in early Alzheimer’s disease exhibit unexpectedly large changes in MMSE scores. Such changes could be explained by a number of re…
View article: Exploring the causes of MMSE scoring and administration errors in the clinical trial screening period
Exploring the causes of MMSE scoring and administration errors in the clinical trial screening period Open
Background Audio recording of eCOA MMSE administration enables identification of both administration and scoring errors. Either can result in incorrect MMSE scores, potentially leading to inclusion of inappropriate subjects and/or biased a…
View article: Consistency checks to improve measurement with the Personal and Social Performance Scale (PSP)
Consistency checks to improve measurement with the Personal and Social Performance Scale (PSP) Open
International Society for CNS Clinical Trials and Methodology convened an expert Working Group that assembled consistency/inconsistency flags for the Personal and Social Performance Scale (PSP). One hundred and forty seven flags were ident…
View article: Depression in Heart Failure: A Systematic Review.
Depression in Heart Failure: A Systematic Review. Open
Objective: This paper sought to identify the instruments used to measure depression in heart failure (HF) and elucidate the impact of treatment interventions on depression in HF. Methods: The Preferred Reporting Items for Systematic Review…
View article: S246. THE EFFECT OF INCORRECT SCALE ADMINISTRATION ON DATA QUALITY IN SCHIZOPHRENIA CLINICAL TRIALS
S246. THE EFFECT OF INCORRECT SCALE ADMINISTRATION ON DATA QUALITY IN SCHIZOPHRENIA CLINICAL TRIALS Open
Background The availability of date and time stamps of interview start times on eCOA systems permits monitoring and documentation of the order of administration of scales and instruments at each visit. The Clinical Global Impression Scale …
View article: The Effects of Erratic Ratings on Placebo Response and Signal Detection in the Roche Bitopertin Phase 3 Negative Symptom Studies—A Post Hoc Analysis
The Effects of Erratic Ratings on Placebo Response and Signal Detection in the Roche Bitopertin Phase 3 Negative Symptom Studies—A Post Hoc Analysis Open
Objective In the current post hoc analyses, we assessed the impact of erratic ratings, a marker of questionable measurement quality, on placebo and drug response and drug-placebo separation in schizophrenia negative symptom trials. Methods…
View article: Issues and Perspectives in Designing Clinical Trials for Negative Symptoms in Schizophrenia: Consensus Statements
Issues and Perspectives in Designing Clinical Trials for Negative Symptoms in Schizophrenia: Consensus Statements Open
Individuals from academia, the pharmaceutical industry, and regulators reevaluated earlier recommendations for the design of clinical trials for negative symptoms based on data from recent large trials. A session in February, 2018 at the I…
View article: F29. EXPLORATORY ANALYSIS OF THE RELATIONSHIP BETWEEN THE CHANGE FROM BASELINE IN PANSS AND BNSS RATING SCALES
F29. EXPLORATORY ANALYSIS OF THE RELATIONSHIP BETWEEN THE CHANGE FROM BASELINE IN PANSS AND BNSS RATING SCALES Open
Schizophrenia with predominant negative symptoms represents a significant unmet medical need. New instruments measuring the severity of negative symptoms are being implemented into clinical trials to improve the ability to accurately measu…
View article: S108. THE RELATIONSHIP BETWEEN CHANGE IN THE CGI AND CHANGE IN THE PANSS VARIES BY REGION
S108. THE RELATIONSHIP BETWEEN CHANGE IN THE CGI AND CHANGE IN THE PANSS VARIES BY REGION Open
We and others have previously demonstrated regional differences in measurement of psychiatric symptoms and in the relationship between the CGI and PANSS. Global clinical trials in schizophrenia pool data utilize the Clinical Global Impress…
View article: T47. IS THERE A DIURNAL VARIATION IN PSYCHIATRIC SYMPTOMS IN SCHIZOPHRENIA?
T47. IS THERE A DIURNAL VARIATION IN PSYCHIATRIC SYMPTOMS IN SCHIZOPHRENIA? Open
Anecdotally we have observed subgroups of schizophrenic patients who experienced a diurnal variation in a wide range of psychiatric symptomology. Such a pattern could have substantial ramifications in both clinical care and clinical trials…
View article: T56. AN EXPLORATORY ANALYSIS CONVERTING SCORES BETWEEN THE PANSS AND BNSS
T56. AN EXPLORATORY ANALYSIS CONVERTING SCORES BETWEEN THE PANSS AND BNSS Open
The Brief Negative Symptom Scale is a relatively new instrument designed specifically to measure the negative symptoms in schizophrenia. Recently more clinical trials include the BNSS scale as a secondary or exploratory outcome, typically …