Alzheimer's & Dementia: The Journal of the Alzheimer's Association
Volume 5, Issue 4 , Pages 324-339 , July 2009

Scales as outcome measures for Alzheimer's disease

  • Ronald Black

      Affiliations

    • Wyeth Research, Collegeville, PA, USA
  • ,
  • Barry Greenberg

      Affiliations

    • Toronto Western Research Institute, Toronto, Ontario, Canada
  • ,
  • J. Michael Ryan

      Affiliations

    • Wyeth Research, Collegeville, PA, USA
  • ,
  • Holly Posner

      Affiliations

    • Eisai Medical Research, Inc., New York, NY, USA
  • ,
  • Jeffrey Seeburger

      Affiliations

    • Merck Research Laboratories, North Wales, PA, USA
  • ,
  • Joan Amatniek

      Affiliations

    • Ortho-McNeil Neurologics, Inc., Raritan, NJ, USA
  • ,
  • Malca Resnick

      Affiliations

    • Forest Laboratories, Inc., New York, NY, USA
  • ,
  • Richard Mohs

      Affiliations

    • Eli Lilly & Co., Indianapolis, IN, USA
  • ,
  • David S. Miller

      Affiliations

    • United BioSource Corporation, Wayne, PA, USA
  • ,
  • Daniel Saumier

      Affiliations

    • Department of Neurology and Neurosurgery, McGill University, Montreal, Quebec, Canada
    • BELLUS Health, Inc., Laval, Quebec, Canada
  • ,
  • Maria C. Carrillo

      Affiliations

    • Alzheimer's Association, Chicago, IL, USA
    • Corresponding Author InformationCorresponding author. Tel.: 312-335-5722; Fax: 866-741-3716.
  • ,
  • Yaakov Stern

      Affiliations

    • Department of Clinical Neuropsychology, Taub Institute, Columbia University, New York, NY, USA

References 

  1. Mckhann G, Drachman D, Folstein M, Katzman R, Price D, Stadlan EM. Clinical diagnosis of Alzheimer's disease: report of the NINCDS-ADRDA Work Group under the auspices of Department of Health and Human Services Task Force on Alzheimer's Disease. Neurology. 1984;34:939–944
  2. Davis KL, Mohs RC, David BM, Horvath TB, Greenwald BS, Rosen WG, et al. Oral physostigmine in Alzheimer's disease. Psychopharmacol Bull. 1983;19:451–453
  3. Mohs RC, Cohen L. Alzheimer's Disease Assessment Scale (ADAS). Psychopharmacol Bull. 1998;24:627–628
  4. Folstein MF, Folstein SE, McHugh PR. Mini-Mental State: a practical method for grading the cognitive state of patients for the clinician. 1975. J Psychiatr Res. 1975;12:189–198
  5. Hughes CP, Berg L, Danziger WL, Coben LA, Martin RL. A new clinical scale for the staging of dementia. Br J Psychiatry. 1982;140:566–572
  6. Galasko D, Bennett D, Sano M, Ernesto C, Thomas R, Grundman M, et al. An inventory to assess activities of daily living for clinical trials in Alzheimer's disease. The Alzheimer's Disease Cooperative Study. Alzheimer Dis Assoc Disord. 1997;11(Suppl. 2):S33–S39
  7. Gelinas I, Gautheir L, McIntyre M, Gauthier S. Development of a functional measure for persons with Alzheimer's Disease: the Disability Assessment for Dementia. Am J Occup Ther. 1998;53:471–481
  8. Schneider LS, Olin JT, Doody RS, Clark CM, Mooris JC, Reisberg B, et al. Validity and reliability of the Alzheimer's Disease Cooperative Study—Clinical Global Impression of Change (ACDS-CGIC). Alzheimer Dis Assoc Disord. 1997;11(Suppl. 2):S22–S32
  9. Cummings JL, Mega M, Gray K, Rosenberg-Thompson S, Carusi DA, Gornbein J. The Neuropsychiatric Inventory: comprehensive assessment of psychopathology in dementia. Neurology. 1994;44:2308–2314
  10. Schneider LS. Prevention therapeutics of dementia. Alzheimers Dement. 2008;4(Suppl. 1):S122–S130
  11. Irizarry MC, Webb DJ, Bains C, Barrett SJ, Lai RY, Laroche JP, et al. Predictors of placebo group decline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) in 24 week clinical trials of Alzheimer's disease. J Alzheimers Dis. 2008;14:301–311
  12. American Psychological Association, National Council on Measurement in Education, American Educational Research Association. Standards for Educational and Psychological Testing. Washington, DC: American Psychological Association; 1999;
  13. 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. Alzheimer Dis Assoc Disord. 1997;11(Suppl.):S21–S31
  14. Saxton J, McGonigle-Gibson KL, Swihart AA, Boller F. The Severe Impairment Battery (SIB) Manual. Pittsburgh, PA: Alzheimer's Disease Research Center; 1993;
  15. Auer SR, Sclan SC, Yaffee RA, Reisberg B. The neglected half of Alzhneimer disease: cognitive and functional concomitants of severe dementia. J Am Geriatr Soc. 1994;42:1266–1272
  16. Hobart JC, Cano SJ, Zajicek JP, Thompson AJ. Raing sales as outcome measuere for clinical trials in neurology: problems, solutions, and recommendations. Lancet Neurol. 2007;6:1094–1105
  17. Lord FM, Novick MR. Statistical Theories of Mental Test Scores. Reading, MA: Addison-Wesley; 1968;
  18. Hambelton RK, Swaminathan H. Item Response Theory: Principles and Applications. Boston: Kluwer-Nijhoff; 1985;
  19. Write BD. Solving measurement problems with the Rasch model. J Educ Meas. 1977;14:97–116
  20. Write BD, Stone MH. Best Test Design: Rasch Measurement. Chicago: MESA; 1979;
  21. Rasch G. Probabilistic Models for Some Intelligence and Attainment Tests. Copenhagen: Danish Institute for Education Research; 1960;
  22. Andrich D. Rasch Models for Measurement. Beverley Hills, CA: Sage; 1988;
  23. Andrich DA. A rating formulation for ordered response categories. Psychometrika. 1978;43:561–573
  24. Sano M, Ernesto C, Thomas RG, Klauber MR, Schafer K, Grundman M, et al. A controlled trial of selegiline, alpha-tocopherol, or both as treatement for Alzheimer's disease. The Alzheimer's Disease Cooperative Study. N Engl J Med. 1997;336:1216–1222
  25. Mulnard RA, Cotman CE, Kawas C, van Dyck CH, Sano M, Doody R, et al. Estrogen replacement therapy for treatment of mild to moderate Alzheimer disease: a randomized controlled trial. Alzheimer's Disease Cooperative Study. JAMA. 2000;283:1007–1015
  26. Petersen RC, Thomas RD, Grundman M, Bennett D, Doody R, Ferris S, et al. Vitamin E and donepezil for the treatment of mild cognitive impairment. N Engl J Med. 2005;352:2379–2388
  27. Aisen PS, Schafer KA, Grundman M, Pfeiffer E, Sano M, Davis KL, et al. Effects of rofecoxib or naproxen vs placebo on Alzheimer disease progression: a randomized controlled trial. JAMA. 2003;289:2819–2826
  28. Aisen PS, Schneider LS, Sano M, Diaz-Arrastia R, van Dyck CH, Weiner MF, et al. High-dose B vitamin supplementation and cognitive decline in Alzheimer disease: a randomized controlled trial. Alzheimer Disease Cooperative Study. JAMA. 2008;300:1774–1783
  29. Thomas RB, Berg JD, Sano M, Thal L. Analysis of longitudinal data in an Alzheimer's disease clinical trial. Stat Med. 2000;19:1433–1440
  30. Dawson JD, Lagakos SW. Size and power of two-sample tests of repeated measures data. Biometrics. 1993;49:1022–1032
  31. Sano M, Zhu CW, Whitehouse PJ, Edland S, Jin S, Ernstrom K, et al. ADCS Prevention Instrument Project: pharamcoeconomics: assessing health-related resource use among healthy elderly. Alzheimer Dis Assoc Disord. 2006;20(Suppl. 3):S191–S202
  32. Ferris SH, Aisen PS, Cummings J, Galasko D, Salmon DP, Schneider L, et al. ADCS Prevention Instrument Project: overview and initial results. Alzheimer Dis Assoc Disord. 2006;20(Suppl. 3):S109–S123
  33. Ferri CP, Prince M, Brayne C, Brodaty H, Fratigliono L, Ganguli M, et al. Global prevalence of dementia: a Delphi Consensus Study. Lancet. 2005;366:2112–2117
  34. Pandav R, Fillenbaum G, Ratcliff G, Dodge H, Ganguli M. Sensitivity and specificity of cognitive and functional screening instruments for Dementia: the Indo-US Dementia Epidemiology Study. J Am Geriatr Soc. 2002;50:554–561
  35. Baiyewu O, Unverzagt FW, Lane KA, Gureje O, Ogunniyi A, Musick B, et al. The Stick Design Test: a new measure of visuoconstructional ability. J Int Neuropsychol Soc. 2005;11:598–605
  36. Grundman M, Petersen RC, Ferris S, Thomas RG, Aisen PS, Bennet DA, et al. Mild cognitive impairment can be distinguished from Alzheimer disease and normal aging for clinical trials. Arch Neurol. 2004;61:59–66
  37. Mueller SG, Weiner MW, Thal LJ, Petersen RC, Jack CR, Jagust W, et al. Ways toward an early diagnosis in Alzheimer's disease: the Alzheimer's Disease Neuroimaging Initiative (ADNI). Alzheimers Dement. 2005;1:55–66
  38. Beekly DL, Ramos EM, Lee WW, Deitrich WD, Jacka ME, Wu J, et al. The National Alzheimer's Coordinating Center (NACC) database: the Uniform Data Set. Alzheimer Dis Assoc Disord. 2007;21:249–258
  39. Geda YE, Roberts RO, Knopman DS, Petersen RC, Christianson TJ, Pankratz VS, et al. Prevalence of neuropsychiatric symptoms in mild cognitive impairment and normal cognitive aging: population-based study. Arch Gen Psychiatry. 2008;65:1193–1198
  40. Mohs RC, Cohen L. Alzheimer's Disease Assessment Scale (ADAS). Psychopharmacol Bull. 1998;24:627–628
  41. Harrison J, Minassian SL, Jenkins L, Black RS, Koller M, Grundman MPH. The NTB: a Neuropsychological Test Battery for use in Alzheimer's disease clinical trials. Arch Neurol. 2007;64:1323–1329
  42. Lewis MS, Maruff PT, Silbert BS. Examination of the use of cognitive domains in postoperative cognitive dysfunction after coronary artery bypass graft surgery. Ann Thorac Surg. 2005;80:910–916
  43. Winblad B, Gauthier S, Scinto L, Feldman H, Wilcock GK, Truyen L, et al. Safety and efficacy of galantamine in subjects with mild cognitive impairment. Neurology. 2008;70:2024–2035
  44. Randolph C, Tierney MC, Mohr E, Chase TN. The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS): preliminary clinical validity. J Clin Exp Neuropsychol. 1998;20:310–319
  45. Yamashima T, Yoshida M, Kumahashi K, Matsui M, Koshino Y, Higashima M, et al. The Japanese version of RBANS (Repeatable Battery for the Assessment of Neuropsychological Status). [in Japanese] No To Shinkei. 2002;54:463–471
  46. McKay C, Wertheimer JC, Fichtenberg NL, Casey JE. The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS): clinical utility in a traumatic brain injury sample. Clin Neuropsychol. 2008;22:228–241
  47. Delle Chiaie R, Salviati M, Fiorentini S, Biondi M. Add-on mirtazapine enhances effects on cognition in schizophrenic patients under stabilized treatment with clozapine. Exp Clin Psychopharamacol. 2007;15:563–568
  48. Wild K, Howieson D, Webbe F, Seelye A, Kaye J. Status of computerized cognitive testing in aging: a systematic review. Alzheimers Dement. 2008;4:428–437
  49. Jones WP, Loe SA, Krach KS, Rager RY, Jones HM. Automated Neuropsychological Assessment Metrics (ANAM) and Woodcock-Johnson III Test of Cognitive Ability: a concurrent validity study. Clin Neuropsychol. 2008;22:305–320
  50. Tornatore JB, Hill E, Laboff J, McGann ME. Self-administered screening for mild cognitive impairment: initial validation of a computerized test battery. J Neuropsychiatry Clin Neurosci. 2005;17:98–105
  51. Robbins TW, James M, Owen AM, Sahakian BJ, Mcinnes L, Rabbitt P. Cambridge Neuropsychological Test Automated Battery (CANTAB): a factor analytic study of a large sample of normal elderly volunteers. Dementia. 1994;5:266–281
  52. Gualtieri CT, Johnson LG. Reliability and validity of a computerized neurocognitive test battery, CNS Vital Signs. Arch Clin Neuropsychol. 2006;21:623–643
  53. Veroff AE, Cutler NR, Sramek JJ, Prior PL, Mickelson W, Hartman JK. A new assessment tool for neuropsychopharmacologic research: the computerized Neuropsychological Test Battery. J Geriatr Psychiatry Neurol. 1991;4:211–217
  54. Simpson PM, Surmon DJ, Wesnes KA, Wilcock GK. The cognitive drug research computerized assessment system for demented patients: a validation study. Int J Geriatr Psychiatry. 2004;6:95–102
  55. Maruff P, Thomas E, Cysique L, Brew B, Collie A, Snyder P, et al. Validity of the CogState Brief Battery: relationship to standardized tests and sensitivity to cognitive impairment in mild traumatic brain injury, schizophrenia, and AIDS dementia complex. Arch Clin Neuropsychol. 2009 March 25;[Epublication ahead of print]
  56. Erlanger DM, Feldman DJ, Kaplan D, Theodoracopulos A. Development and validation of the cognitive stability index, a web-based protocol for monitoring change in cognitive function. Arch Clin Neuropsychol. 2000;15:693–694
  57. Trenkle DL, Shankle WR, Azen SP. Detecting cognitive impairment in primary care: performance assessment of three screening instruments. J Alzheimers Dis. 2007;11:323–335
  58. Johnson JA, Rust JO. Correlational analysis of MicroCog: assessment of cognitive functioning with the Wechsler Adult Intelligence Scale-III for a clinical sample of veterans. Psychol Rep. 2003;93:1261–1266
  59. Dwolatzky T, Whitehead V, Doniger GM, Simon ES, Schweiger A. Validity of a novel computerized cognitive battery for mild cognitive impairment. BMC Geriatr. 2003;3:4
  60. Bowie CR, Reichenberg A, Patterson TL, Heaton RK, Harvey PD. Determinants of real-world functional performance in schizophrenia subjects: correlations with cognition, functional capacity, and symptoms. Am J Psychiatry. 2006;163:418–425
  61. Patterson TL, Goldman S, McKibbin CL, Hughs T, Jeste DV. UCSD performance based skills assessment: development of a new measure of everyday functioning for severely mentally ill adults. Schizophr Bull. 2001;27:235–245
  62. Feldman H, Gauthier S, Hecker J, Vellas B, Subbiah P, Whalen E. Donepezil MSAD Study Investigators Group. Neurology. 2001;57:613–620
  63. DuBois B, Feldman HH, Jacova C, DeKosky ST, Barberger-Gateau P, Cummings J, et al. Research criteria for the diagnosis of Alzheimer's disease: revising the NINCDS-ADRDA criteria. Lancet Neurol. 2007;6:734–746
  64. Hsiung GR, Alipour S, Jacova C, Grand J, Gauthier S, Black S, et al. Transition from cognitively impaired not demented to Alzheimer's disease: an analysis of changes in functional abilities in a dementia clinic cohort. Dement Geriatr Cogn Disord. 2008;25:483–490
  65. Katz S, Ford AB, Moskowitz RW, Jackson BA, Jaffe MW. Studies of illness in the aged. The index of ADL: a standardized measure of biological and psychosocial function. JAMA. 1963;185:914–919
  66. Winblad B, Palmer K, Kivipelto M, Jelic V, Fratiglioni L, et al. Mild cognitive impairment—beyond controversies, towards a consensus: report of the International Working Group on Mild Cognitive Impairment. J Intern Med. 2004;256:240–246
  67. Farias S, Mungas D, Reed B, Harvey D, Cahn-Weiner D, DeCarli C. MCI is associated with deficits in everyday functioning. Alzheimer Dis Assoc Disord. 2006;20:217–223
  68. Purser J, Fillenbaum G, Wallace R. Memory complaint is not necessary for diagnosis of mild cognitive impairment and does not predict 10-year trajectories of functional disability, word recall, or short portable mental status questionnaire limitations. J Am Geriatr Soc. 2006;54:335–338
  69. Peres K, Chrysostome V, Fabrigoule C, Orgogozo J, Dartigues J, Bargerger-Gateau P. Restriction in complex activities of daily living in MCI: impact on outcome. Neurology. 2006;67:461–466
  70. Daly E, Zaitchik D, Copeland M, Schmahmann J, Gunther J, Albert M. Predicting conversion to Alzheimer disease using standardized clinical information. Arch Neurol. 2000;57:675–680
  71. Perneczky R, Pohl C, Sorg C, Hartmann J, Tosic N, Grimmer T, et al. Impairment of activities of daily living requiring memory or complex reasoning as part of the MCI syndrome. Int J Geriatr Psychiatry. 2006;21:158–162
  72. Farias S, Mungas D, Reed B, Cahn-Weiner D, Jagust W, Baynes K, et al. The measurement of everyday cognition (ECog): scale development and psychometric properties. Neuropsychology. 2008;22:531–544
  73. Jorm A, Korten E. Assessment of cognitive decline in the elderly by informant interview. Br J Psychiatry. 1988;152:209–213
  74. Glosser G, Gallo J, Duda N. Visual perceptual functions predict instrumental activities of daily living in patients with dementia. Neuropsychiatry Neuropsychol Behav Neurol. 2002;15:198–206
  75. Pfeffer R, Kurosaki C, Harrah J, Chance S, Filos S. Measurement of functional activities of daily living of older adults in the community. J Gerontol. 1982;37:323–329
  76. Galvin J, Roe C, Xiong C, Morris J. Validity and reliability of the AD8 informant interview in dementia. Neurology. 2006;67:1942–1948
  77. Grigsby J, Kaye K, Baxter J, Shetterly SM, Hamman RF. Executive cognitive abilities and functional status among community-dwelling older person in the San Luis Valley Health and Aging Study. J Am Geriatr Soc. 1998;46:590–596
  78. Cahn-Weiner DA, Malloy PF, Boyle PA, Marran M, Salloway S. Prediction of functional status from neuropsychological tests in community-dwelling elderly individuals. Clin Neuropsychol. 2000;14:187–195
  79. Farias ST, Harrell E, Neumann C, Houtz A. The relationship between neuropsychological performance and daily functioning in individuals with Alzheimer's disease: ecological validity of neuropsychological tests. Arch Clin Neuropsychol. 2003;18:655–672
  80. Farias ST, Mungas D, Jagust W. Degree of discrepancy between self and other-reported everyday functioning by cognitive status: dementia, mild cognitive impairment, and healthy elders. Int J Geriatr Psychiatry. 2005;20:827–834
  81. Cahn DA, Malloy PF, Salloway S, Rogg J, Gillard E, Kohn R, et al. Subcortical hyperintensities on MRI and activities of daily living in geriatric depression. J Neuropsychiatry Clin Neurosci. 1996;8:404–411
  82. Cahn-Weiner DA, Farias ST, Julian L, Harvey DJ, Kramer JH, Reed BR, et al. Cognitive and neuroimaging predictors of instrumental activities of daily living. J Int Neuropsychol Soc. 2007;13:747–757
  83. Farias ST, Mungas D, Reed B, Haan MN, Jagust WJ. Everyday functioning in relation to cognitive functioning and neuroimaging in community-dwelling Hispanic and non-Hispanic older adults. J Int Neuropsychol Soc. 2004;10:342–354
  84. Boyle PA, Paul RH, Moser DJ, Cohen RA. Executive impairments predict functional declines in vascular dementia. Clin Neuropsychol. 2004;18:75–82
  85. Tomaszewski Farisa S, Cahn-Weiner DA, Harvey DJ, Reed BR, Mungas D, Kramer JH, et al. longitudinal changes in memory and executive functioning are associated with longitudinal change in instrumental activities of daily living in older Adults. Clin Neuropsychol. 2008;23:1–16
  86. Profenno L. Dementia. 3rd ed.. London: Hodder Arnold;; 2005;
  87. Overall JE, Gorham DR. Brief Psychiatric Rating Scale. Psychol Rep. 1962;10:799–812
  88. Teri L, Truax P, Logsdon R, Uomoto J, Zarit S, Vitaliano PP. Assessment of behavioral problems in dementia: the Revised Memory and Behavior Problems Checklist. Psychol Aging. 1992;7:622–631
  89. Helmes E, Csapo KG, Short JA. Standardization and validation of the Multidimensional Observation Scale for Elderly Subjects (MOSES). J Gerontol. 1987;42:395–405
  90. Morris JC, Heyman A, Mohs RC, Hughes JP, van Velle G, Fillenbaum G, et al. The Consortium to Establish a Registry for Alzheimer's Disease (CERAD): part 1—clinical and neuropsychological assessment of Alzheimer's disease. Neurology. 1989;39:1159–1165
  91. Mirra S, Heyman A, McKeel D, Sumi SM, Crain BJ, Brownlee LM, et al. The Consortium to Establish a Registry for Alzheimer's Disease (CERAD): part II—standardization of the neuropathologic assessment of Alzheimer's disease. Neurology. 1991;41:479–486
  92. Wilkinson IM, Graham-White J. Psychogeriatric dependency rating scales (PGDRS): a method of assessment for use by nurses. Br J Psychiatry. 1980;137:558–565
  93. Olin J, Fox LS, Pawluczyk S, Taggart N, Schneider LS. A pilot randomized trial of carbamazepine for behavioral symptoms in treatment-resistant outpatients with Alzheimer's disease. Am J Geriatr Psychiatry. 2001;9:400–405
  94. De Deyn PP, Rabheru K, Rasmussen A, Bocksberger JP, Dautzenberg LJ, Eriksson S, et al. A randomized trial of risperidone, placebo, and haloperidol for behavioral symptoms of dementia. Neurology. 1999;53:946–950
  95. Paleacu D, Barak Y, Mirecky I, Mazeh D. Quetiapine treatment for behavioral and psychological symptoms of dementia in Alzheimer's disease patients: a 6-week, double-blind, placebo-controlled study. Int J Geriatr Psychiatry. 2008;23:393–400
  96. Lott AD, McElroy SL, Keys MA. Valproate in the treatment of behavioral agitation in elderly patients with dementia. J Neuropsychiatry Clin Neurosci. 1995;7:314–319
  97. Tariot PN, Solomon PR, Morris JC, Kershaw P, Lilienfeld S, Ding C. A 5-month, randomized, placebo-controlled trial of galantamine in AD. Neurology. 2000;54:2269–2276
  98. Schnieder LS, Tariot PN, Dagerman KS, Davis SM, Hsaio JK, Ismail MS, et al. Effectiveness of atypical antipsychotic drugs in patients with Alzheimer's disease. N Engl J Med. 2006;355:1525–1538
  99. Profenno LA, Jamimovich L, Holt CJ, Porsteinsson A, Tariot PN. A randomized, double-blind, placebo-controlled pilot trial of safety and tolerability of two doses of divalproex sodium in outpatients with probable Alzheimer's disease. Curr Alzheimer Res. 2005;2:553–558
  100. Tschanz JT, Treiber K, Norton MC, Welsh-Bohmer KA, Toone L, Zandi PP, et al. A population study of Alzheimer's disease: findings from the Cache County Study of Memory, Health and Aging. Care Manag J. 2005;6:107–114
  101. Lyketsos CG. Neuropsychiatric symptoms (behavioral and psychological symptoms of dementia) and the development of dementia treatments. Int Psychogeriatr. 2007;19:409–420
  102. Knopman DS, Knapp MJ, Gracon SI, Davis CS. The clinician interview-based impression (CIBI): a clinician's global change rating scale in Alzheimer's disease. Neurology. 1994;44:2315–2321
  103. Rockwood K, Joffres C. Improving clinical descriptions to understand the effects of dementia treatment: consensus recommendations. Halifax Consensus Conference on Understanding the Effects of Dementia Treatment. Int J Geriatr Psychiatry. 2002;17:1006–1011
  104. Morris JC, McKeel DW, Fulling K, Torack RM, Berg L. Validation of clinical diagnostic criteria for Alzheimer's disease. Ann Neurol. 1998;24:17–22
  105. Berg L, Miller JP, Baty J, Rubin EH, Morris JC, Figiel G. Mild senile dementia of the Alzheimer type. 4. Evaluation of intervention. Ann Neurol. 1992;31:242–249
  106. Mulnard RA, Cotman CW, Kawas C, van Dyck CH, Sano M, Doody R, et al. Estrogen replacement therapy for treatment of mild to moderate Alzheimer disease: a randomized controlled trial. Alzheimer's Disease Cooperative Study. JAMA. 2000;283:1007–1015
  107. Rockwood K. Capacity, population aging and professionalism. Can Med Assoc J. 2006;174:1689
  108. In:  Kiresuk T,  Smith A,  Cardillo J editor. Goal Attainment Scaling: Application, Theory, and Measurement. Hillsdale, NJ: Lawrence Erlbaum; 1994;
  109. Rockwood K, Li Y, Fay S, Mitnitski A. Patient/care partner goals of dementia treatment: comparing clinical trial and web-based accounts. Alzheimers Dement. 2008;4(Suppl. 2):T174
  110. Rockwood K, Fay S, Jarrett P, Asp E. Effect of galantamine on verbal repetition in AD: a secondary analysis of the VISTA Trial. Neurology. 2007;68:1116–1121
  111. Guidance for industry patient reported outcome measures: use in medical product development to support labeling claims. February 2, 2006. Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071975.pdf.
  112. Guidance for industry and review staff: target product profile—a strategic development process tool. March 30, 2007. Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080593.pdf.
  113. Caron M, Emery MP, Marquis P, Piault E, Scott J. Recent trends in the inclusion of patient-reported outcome data in approved drugs labeling by the FDA and EMEA. Patient Reported Outcomes Online. Available at: http://www.pro-newsletter.com/index.php?option=com_content&task=view&id=224&Itemid=77.
  114. Mueller SG, Weiner MW, Thal LJ, Petersen RC, Jack CR, Jagust W, et al. Ways toward an early diagnosis in Alzheimer's disease: the Alzheimer's Disease Neuroimaging Initiative (ADNI). Alzheimers Dementia. 2005;1:55–66
  115. Shaw LM. PENN biomarker core of the Alzheimer's Disease Neuroimaging Initiative. Neurosignals. 2008;16:19–23
  116. Shaw LM, Vanderstichele H, Knapik-Czajka M, Clark CM, Aisen PS, Petersen RC, et al. Cerebrospinal fluid biomarker signature in Alzheimer's Disease Neuroimaging Initiative subjects. Ann Neurol. 2009;65:403–413
  117. Landau SM, Madison C, Wu D, Cheung C, Foster N, Reiman E, et al. Pinpointing change in Alzheimer's disease: longitudinal FDG-PET analysis from the Alzheimer's Disease Neuroimaging Initiative (ADNI). Alzheimers Dement. 2008;4(Suppl 2):T291–T292
  118. Carrillo MC, Sanders CA, Katz RG. Maximizing the Alzheimer's Disease Neuroimaging Initiative (ADNI) II. Alzheimers Dement. 2009;5:271–275

PII: S1552-5260(09)02015-9

doi: 10.1016/j.jalz.2009.05.667

Alzheimer's & Dementia: The Journal of the Alzheimer's Association
Volume 5, Issue 4 , Pages 324-339 , July 2009