Improved utilization of ADAS-Cog assessment data through item response theory based pharmacometric modeling

Pharmaceutical Research

Volumn 31, Issue 8, 2014, Pages 2152-2165

  Ueckert, Sebastian ^a   Plan, Elodie L ^a,b   Ito, Kaori ^c   Karlsson, Mats O ^a   Corrigan, Brian ^c   Hooker, Andrew C ^a  

^a UPPSALA UNIVERSITY   (Sweden)

^b Metrum Research Group   (United States)

^c PFIZER INC   (United States)

Author keywords

ADAS cog; Alzheimer's disease; item response theory; nonlinear mixed effect models; pharmacometrics

Indexed keywords

ATORVASTATIN; HEPTANOIC ACID DERIVATIVE; PYRROLE DERIVATIVE;

ALZHEIMER DISEASE; BIOLOGICAL MODEL; COGNITION DISORDERS; FACTUAL DATABASE; HUMAN; LONGITUDINAL STUDY; PHASE 3 CLINICAL TRIAL (TOPIC); PSYCHOLOGY; STANDARDS; STATISTICS;

ALZHEIMER DISEASE; CLINICAL TRIALS, PHASE III AS TOPIC; COGNITION DISORDERS; DATABASES, FACTUAL; HEPTANOIC ACIDS; HUMANS; LONGITUDINAL STUDIES; MODELS, BIOLOGICAL; PYRROLES; STATISTICS AS TOPIC;

EID: 84894614505     PISSN: 07248741     EISSN: 1573904X     Source Type: Journal    
DOI: 10.1007/s11095-014-1315-5     Document Type: Article

References (20)

1. Harrison J. Detecting pro-cognitive effects in clinical drug trials: case studies from Alzheimer's disease. J Patient Compliance. 2011;1:42-4.
2. Raghavan N, Samtani MN, Farnum M, Yang E, Novak G, Grundman M, et al. The ADAS-cog revisited: novel composite scales based on ADAS-Cog to improve efficiency in MCI and early AD trials. Alzheimers Dement. 2013;9:S21-31.
3. Balsis S, Unger AA, Benge JF, Geraci L, Doody RS. Gaining precision on the Alzheimer's disease assessment scale-cognitive: a comparison of item response theory-based scores and total scores. Alzheimers Dement. 2012;8:288-94.
4. Ard MC, Galasko DR, Edland SD. Improved statistical power of Alzheimer clinical trials by item-response theory: proof of concept by application to the activities of daily living scale. Alzheimer Dis Assoc Disord. 2013;27:187-91.
5. DeMars C. Item response theory. Oxford: Oxford University Press; 2010.
6. Rosen WG, Mohs RC, Davis KL. A new rating scale for Alzheimer's disease. Am J Psychiatry. 1984;141:1356-64.
7. Mohs RC, Knopman D, Petersen RC, Ferris SH, Ernesto C, Grundman M, et al. Development of cognitive instruments for use in clinical trials of antidementia drugs: additions to the Alzheimer's Disease Assessment Scale that broaden its scope. The Alzheimer's Disease Cooperative Study. Alzheimer Dis Assoc Disord. 1997;11 Suppl 2:S13-21.
8. Collett D. Modelling binary data. Chapman & Hall/CRC: Boca Raton; 2003.
9. Cameron AC. Regression analysis of count data. Cambridge: Cambridge University Press, Colin Cameron; 2013.
10. Plan EL, Maloney A, Trocóniz IF, Karlsson MO. Performance in population models for count data, part I: maximum likelihood approximations. J Pharmacokinet Pharmacodyn. 2009;36:353-66.
11. Kjellsson MC, Zingmark P-H, Jonsson EN, Karlsson MO. Comparison of proportional and differential odds models for mixed-effects analysis of categorical data. J Pharmacokinet Pharmacodyn. 2008;35:483-501.
12. Beal S, Sheiner LB, Boeckmann A, Bauer RJ. NONMEM user's guides (1989-2009). Ellicott City: Icon Development Solutions; 2009.
13. Wood SN. Introducing GAMs. Gen Addit Models Introd. R. Chapman and Hall/CRC Press; 2006.
14. Feldman HH, Doody RS, Kivipelto M, Sparks DL, Waters DD, Jones RW, et al. Randomized controlled trial of atorvastatin in mild to moderate Alzheimer disease: LEADe. Neurology. 2010;74:956-64.
15. Jones RW, Kivipelto M, Feldman H, Sparks L, Doody R, Waters DD, et al. The Atorvastatin/Donepezil in Alzheimer's disease study (LEADe): design and baseline characteristics. Alzheimers Dement. 2008;4:145-53.
16. Ito K, Corrigan B, Zhao Q, French J, Miller R, Soares H, et al. Disease progression model for cognitive deterioration from Alzheimer's disease neuroimaging initiative database. Alzheimers Dement. 2011;7:151-60.
17. Hu C, Sale ME. A joint model for nonlinear longitudinal data with informative dropout. J Pharmacokinet Pharmacodyn. 2003;30:83-103.
18. Team RDC. R: a language and environment for statistical computing [Internet]. Vienna, Austria; 2012. Available from: http://www.R-project.org.
19. Pinheiro J, Bates D, DebRoy S, Sarkar D. R development core team. nlme: linear and nonlinear mixed effects models. 2013.
20. Karlsson KE, Vong C, Bergstrand M, Jonsson EN, Karlsson MO. Comparisons of analysis methods for proof-of-concept trials. CPT Pharmacomet Syst Pharmacol. 2013;2:e23.