Psychometric evaluation of ADAS-Cog and NTB for measuring drug response

Acta Neurologica Scandinavica

Volumn 129, Issue 2, 2014, Pages 114-122

  Karin, A ^a   Hannesdottir, K ^b   Jaeger, J ^b,c   Annas, P ^a   Segerdahl, M ^a   Karlsson, P ^a   Sjogren N ^a   von Rosen, T ^d   Miller, F ^a  

^a ASTRAZENECA R AND D   (Sweden)

^b ASTRAZENECA   (United Kingdom)

^c Scientific Division   (United States)

^d STOCKHOLM UNIVERSITY   (Sweden)

Author keywords

Acceptability; Alzheimer's disease; Alzheimer's Disease Assessment Scale Cog; Ceiling effects; Cognitive testing; Neuropsychological test battery; Psychometric properties; Validation

Indexed keywords

DONEPEZIL; PLACEBO;

ADULT; AGED; ALZHEIMER DISEASE; ARTICLE; AZHEIMER DISEASE ASSESSMENT SCALE COGNITION; CLINICAL ASSESSMENT TOOL; CONTROLLED STUDY; CONVERGENT VALIDITY; DELIS KAPLAN EXECUTIVE FUNCTION SYSTEM; DISCRIMINANT VALIDITY; DRUG RESPONSE; FACTORIAL ANALYSIS; FEMALE; HUMAN; INTERNAL CONSISTENCY; LANGUAGE ABILITY; MAJOR CLINICAL STUDY; MALE; MINI MENTAL STATE EXAMINATION; MULTICENTER STUDY; NEUROLOGIC EXAMINATION; NEUROPSYCHOLOGICAL TEST; NEUROPSYCHOLOGICAL TEST BATTERY; PSYCHOMETRY; REY AUDITORY VERBAL LEARNING TEST; TEST RETEST RELIABILITY; VERBAL FLUENCY CONDITION; VERY ELDERLY; WECHSLER MEMORY SCALE;

ACCEPTABILITY; ALZHEIMER'S DISEASE; ALZHEIMER'S DISEASE ASSESSMENT SCALE-COG; CEILING EFFECTS; COGNITIVE TESTING; NEUROPSYCHOLOGICAL TEST BATTERY; PSYCHOMETRIC PROPERTIES; VALIDATION;

AGED; AGED, 80 AND OVER; ALZHEIMER DISEASE; COGNITION; FEMALE; HUMANS; INDANS; MALE; MIDDLE AGED; NEUROPSYCHOLOGICAL TESTS; NOOTROPIC AGENTS; PIPERIDINES; PSYCHOMETRICS; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 84891948115     PISSN: 00016314     EISSN: 16000404     Source Type: Journal    
DOI: 10.1111/ane.12153     Document Type: Article

References (29)

1. Frölich L, Ashwood T, Nilsson J, Eckerwall G. Effects of AZD3480 on cognition in patients with mild-to-moderate Alzheimer's disease: a phase IIb dose-finding study. J Alzheimers Dis 2011;24:363-74.
2. Gold M, Alderton C, Zvartau-Hind M et al. Rosiglitazone monotherapy in mild-to-moderate Alzheimer's disease: results from a randomized, double-blind, placebo-controlled phase III study. Dement Geriatr Cogn Disord 2010;30:131-46.
3. Sotaniemi M, Pulliainen V, Hokkanen L et al. CERAD-neuropsychological battery in screening mild Alzheimer's disease. Acta Neurol Scand 2012;125:16-23.
4. Mohs K, Rosen W, Davis K. The Alzheimer's disease assessment scale: an instrument for assessing treatment efficacy. Psychopharmacol Bull 1983;19:448-50.
5. Rosen WG, Mohs RC, Davis KL. A new rating scale for Alzheimer's disease. Am J Psychiatry 1984;141:1356-64.
6. Harrison J, Minassian SL, Jenkins L, Black RS, Koller M, Grundman M. A neuropsychological test battery for use in Alzheimer disease clinical trials. Arch Neurol 2007;64:1323-9.
7. Ferris S, Lucca U, Mohs R et al. Objective psychometric tests in clinical trials of dementia drugs. Position paper from the international Working Group on Harmonization of Dementia Drug Guidelines. Alzheimer Dis Assoc Disod 1997;11:34-8.
8. Ihl R, Frölich L, Dierks T, Martin EM, Maurer K. Differential validity of psychometric tests in dementia of the Alzheimer type. Psychiatry Res 1992;44:93-106.
9. Kurz A, Farlow M, Quarg P, Spiegel R. Disease stage in Alzheimer disease and treatment effects of rivastigmine. Alzheimer Dis Assoc Disor 2004;18:123-8.
10. Seltzer B, Zolnouni P, Nunez M et al. Efficacy of donepezil in early-stage Alzheimer disease: a randomized placebo-controlled trial. Arch Neurol 2004;61:1852-6.
11. Wilcock GK, Lilienfeld S, Gaens E. Efficacy and safety of galantamine in patients with mild-to-moderate Alzheimer's disease: multicentre randomised controlled trial. Galantamine International-1 Study Group. Br Med J 2000;321:1445-9.
12. Cano SJ, Posner HB, Moline ML et al. The ADAS-cog in Alzheimer's disease clinical trials: psychometric evaluation of the sum and its parts. J Neurol Neurosurg Psychiatry 2010;81:1363-8.
13. Grundman MPH, Petersen RC, Ferris SH, the Alzheimer's Disease Cooperative Study. Mild cognitive impairment can be distinguished from Alzheimer's disease and normal aging for clinical trials. Arch Neurol 2004;61:59-66.
14. Harrison J, Caveney A. 10 years of the neuropsychological test battery (NTB). PRO Newsletter 2011;45:21-4.
15. Schneider LS, Olin JT, Doody RS et al. Validity and reliability of the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change. The Alzheimer's Disease Cooperative Study. Alzheimer Dis Assoc Disor 1997;11:22-32.
16. Folstein MF, Folstein SE, McHugh PR. Mini-mental state. A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res 1975;12:189-98.
17. Black R, Greenberg B, Ryan JM et al. Scales as outcome measures for Alzheimer's disease. Alzheimers Dement 2009;5:324-39.
18. Vellas B, Andrieu S, Sampaio C, Coley N, Wilcock G. European Task Force Group. Endpoints for trials in Alzheimer's disease: a European task force consensus. Lancet Neurol 2008;7:436-50.
19. Food and Drug Administration. Guidance for Industry. Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. 2009; http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf (accessed 15 May 2013).
20. Lamping DL, Schroter S, Marquis P, Marrel A, Duprat-Lomon I, Sagnier P. The community-acquired pneumonia symptom questionnaire: a new, patient-based outcome measure to evaluate symptoms in patients with community-acquired pneumonia. Chest 2002;122:920-9.
21. Cronbach LJ. Coefficient alpha and the internal structure of tests. Psychometrika 1951;16:297-334.
22. Shrout PE, Fleiss JL. Intraclass correlations: uses in assessing rater reliability. Psychol Bull 1979;86:420-8.
23. Fleiss JL. Reliability of measurement. In: Fleiss JL, ed. The design and analysis of clinical experiments. Toronto: Wiley, 1986;1-32.
24. Streiner DL, Norman GR. Health measurement scales. A practical guide to their development and use, 2nd edn. Oxford: Oxford medical publications, 1995;120-2.
25. Cohen J. Statistical power analysis for the behavioral sciences, 2nd edn. Hillsdale, NJ: Lawrence Erlbaum Associates, Inc. Publishers, 1988, 25-7.
26. Gilman S, Koller M, Black RS et al. Clinical effects of Aβ immunization (AN1792) in patients with AD in an interrupted trial. Neurology 2005;64:1553-62.
27. Faux NG, Ritchie CW, Gunn A et al. PBT2 rapidly improves cognition in Alzheimer's disease: additional phase II analysis. J Alzheimers Dis 2010;20:509-16.
28. Scheltens P, Twisk JWR, Blesa R et al. Efficacy of Souvenaid in mild Alzheimer's disease: results from a randomized, controlled trial. J Alzheimers Dis 2012;31:225-36.
29. Hobart JC, Cano SJ, Zajicek JP, Thompson AJ. Rating scales as outcome measure for clinical trials in neurology: problems, solutions, and recommendations. Lancet Neurol 2007;6:1094-105.