Cognitive testing in early-phase clinical trials: Development of a rapid computerized test battery and application in a simulated Phase I study

• Published in: Contemporary clinical trials Vol. 28; no. 4; pp. 391 - 400
• Main Authors: Collie, Alex, Darekar, Amanda, Weissgerber, Georges, Toh, Melvin K., Snyder, Peter J., Maruff, Paul, Huggins, John P.
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 01.07.2007; Elsevier
• Subjects: Adolescent; Adult; Adverse event; Biological and medical sciences; Brain - drug effects; Cardiovascular; Clinical trial; Clinical trial. Drug monitoring; Clinical Trials, Phase I as Topic - statistics & numerical data; Cognition; Cognition - drug effects; CogState; Diagnosis, Computer-Assisted; Dose-Response Relationship, Drug; Double-Blind Method; General pharmacology; Hematology, Oncology and Palliative Medicine; Humans; Hypnotics and Sedatives - pharmacology; Hypnotics. Sedatives; Male; Medical sciences; Midazolam; Midazolam - pharmacology; Middle Aged; Multicenter Studies as Topic - statistics & numerical data; Neuropharmacology; Neuropsychological Tests - statistics & numerical data; Pharmacology. Drug treatments; Phase I; Psychology. Psychoanalysis. Psychiatry; Psychometrics - statistics & numerical data; Psychopharmacology; Research Design; Sensitivity and Specificity; Adverse event; Clinical trial; Cognition; Phase I; Midazolam; CogState; Human; Pharmacokinetic pharmacodynamic relationship; Psychotropic; Toxicity; Early phase; Central nervous system; Hypnotic; Medical screening; Treatment; Development; Secondary effect; Phase I trial; Benzodiazepine derivatives; Sedative

Inclusion of cognitive assessment in Phase I trials of novel pharmaceutical agents may help identify subtle yet meaningful CNS effects early in clinical development, and lead to a greater understanding of the pharmacokinetic/pharmacodynamic relationship prior to entering pivotal late-phase trials. T...