Cognitive testing in early phase clinical trials: Outcome according to adverse event profile in a Phase I study

Human Psychopharmacology

Volumn 21, Issue 7, 2006, Pages 481-488

  Collie, Alex ^a,b,f   Maruff, Paul ^a,c   Snyder, Peter J ^d   Darekar, Amanda ^e   Huggins, John P ^e  

^a CogState Limited ^*  (Australia)

^b UNIVERSITY OF MELBOURNE   (Australia)

^c LA TROBE UNIVERSITY   (Australia)

^d UNIVERSITY OF CONNECTICUT   (United States)

^e PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United Kingdom)

^f NONE   (Australia)

Author keywords

Adverse event; Cognition; Cogstate; Midazolam; Phase I; Sedation

Indexed keywords

MIDAZOLAM;

ADULT; ARTICLE; ATTENTION; AUTOMATION; CLINICAL OBSERVATION; CLINICAL TRIAL; COGNITION; COGNITIVE DEFECT; CONFUSION; CONTROL STRATEGY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIZZINESS; DOSE RESPONSE; FATIGUE; HEADACHE; HUMAN; HUMAN EXPERIMENT; LEARNING TEST; MALE; MAZE TEST; MOTOR PERFORMANCE; NORMAL HUMAN; OUTCOME ASSESSMENT; PAIN; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; PROBLEM SOLVING; PROCESS MODEL; PSYCHOLOGIC TEST; RECALL; SELF REPORT; SOMNOLENCE; TASK PERFORMANCE; VOLUNTEER;

ADOLESCENT; ADULT; CLINICAL TRIALS, PHASE I; COGNITION; CROSS-OVER STUDIES; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG THERAPY; HUMANS; HYPNOTICS AND SEDATIVES; MALE; MIDAZOLAM; MIDDLE AGED; PSYCHOLOGICAL TESTS;

EID: 33750511264     PISSN: 08856222     EISSN: 10991077     Source Type: Journal    
DOI: 10.1002/hup.799     Document Type: Article

References (21)

1. Beglinger LJ, Gaydos BL, Kareken DA, Tangphao-Daniels O, Siemers ER, Mohs RC. 2004. Neuropsychological test performance in healthy volunteers before and after donepezil administration. J Psychopharm 18(1): 102-108.
2. Beglinger LJ, Gaydos B, Tangphao-Daniels O, et al. 2005a. Practice effects and the use of alternate forms in serial neuropsychological testing. Arch Clinl Neuropsychol 20(4): 517-529.
3. Beglinger LJ, Tangphao-Daniels O, Kareken DA, Thang L, Mohs R, Siemers ER. 2005b. Neuropsychological test performance in healthy elderly volunteers before and after donepezil adminisiration: a randomized, controlled study. J Clin Psychopharm 25(2): 159-165.
4. Bland M, Alman D. 1996. Measurement error. BMJ 313: 744.
5. Cohen J. 1988. Statistical power analysis for the behavioural sciences, 2nd edn. Erlbaum: Hillsdale, NJ.
6. Collie A, Maruff P, Darby DG, McStephen M. 2003. The effects of practice on the cognitive test performance of neurologically normal individuals assessed at brief test-retest intervals. J Int Neuropsychol Soc 9(3): 419-428.
7. Collie A, Darekar A, Weissgerber G, et al. 2005. Cognitive testing in early phase clinical trials: Development of a rapid computerised test battery and application in a simulated Phase I study. Manuscript submitted for publication.
8. Falleti MG, Maruff P, Collie A, Darby DG, McStephen M. 2003. Qualitative similarities in cognitive impairment associated with 24 h of sustained wakefulness and a blood alcohol concentration of 0.05%. J Sleep Res 12: 265-274.
9. Girdler NM, Lyne JP, Wallace R, et al. 2002. A randomized, controlled trial of cognitive and psychomotor recovery from midazolam sedation following reversal with oral flumazenil. Anaesthesia 57(9): 868-476.
10. Grundman M, Farlow M, Peavy G, et al. 2002. A phase I study of AIT-082 in healthy elderly volunteers. J Mol Neurosci 18(3): 283-293.
11. Ingraham LJ, Aiken CB. 1996. An empirical approach to determining criteria for abnormality in test batteries with multiple measures. Neuropsychology 10: 120-124.
12. Kanto JH. 1985. Midazolam: the first water-soluble benzodiazepine. Pharmacology, pharmacokinetics and efficacy in insomnia and anesthesia. Pharmacotherapy 5(3): 138-155.
13. Kliegel M, Zimprich D, Eschen A. 2005. What do subjective cognitive complaints in persons with aging-associated cognitive decline reflect? Int Psychogeriatr 17(3): 499-512.
14. Meyers CA, Hess KR, Yung WK, Levin VA. 2000. Cognitive function as a predictor of survival in patients with recurrent malignant glioma. J Clin Oncol 18(3): 646-650.
15. Mollica CM, Maruff P, Vance P. 2004. Development of a statistical approach to classifying treatment response in individual children with ADHD. Hum Psychopharm 19(7): 445-456.
16. Nordst SP, Clark RF. 1997. Midazolam: a review of therapeutic uses and toxicity. J Emerg Med 15(3): 357-365.
17. Rasmussen LS, Larsen K, Houx P, et al 2001. The assessment of postoperative cognitive function. Acta Anaesthes Scand 45: 275-289.
18. Rogers JF, Morrison AL, Nafziger AN, Jones CL, Rocci ML, Jr. Bertino JS, Jr. 2002. Flumazenil reduces midazolam-induced cognitive impairment without altering pharmacokinetics. Clin Pharmacol Ther 72(6): 711-717.
19. Snyder PJ, Werth J, Giordani B, Caveney AF, Feltner D, Maruff P. 2005. A method for determining the magnitude of change across different cognitive functions in clinical trials: the effects of acute administration of two different doses of alprazolam. Hum Psychopharm 20(4): 263-273.
20. Thompson JM, Neave N, Moss MC, Scholey AB, Wesnes K, Girdler NM. 1999. Cognitive properties of sedation agents: comparison of the effects of nitrous oxide and midazolam on memory and mood. Brit Dent J 187: 557-563.
21. van der Meyden CH, Bartel PR, Sommers DK, et al. 1992. Effect of acute doses of controlled-release carbamazepine on clinical, psychomotor, electrophysiological, and cognitive parameters of brain function. Epilepsia 33(2): 335-342.