1. Schott JM, Aisen PS, Cummings JL, Howard RJ, Fox NC. Unsuccessful trials of therapies for Alzheimer’s disease. Lancet 2019;393:29
4. Committee for Medicinal Products for Human Use (CHMP). Guideline on the clinical investigation of medicines for the treatment of Alzheimer’s disease. London: European Medicines Agency; 2018.
5. Takeshima N, Ishiwata K, Sozu T, Furukawa TA. Primary endpoints in current phase II/III trials for Alzheimer disease: a systematic survey of trials registered at ClinicalTrials.gov. Alzheimer Dis Assoc Disord 2020;34:97-100.
6. US Food and Drug Administration. Study data technical conformance guide. Silver Spring, MD: US Food and Drug Administration; 2016.
8. Downey AS, Olson S. Sharing clinical research data: workshop summary. Washington, DC: National Academies Press; 2013.
10. Team CAsD. CDISC Therapeutic Area Data Standards User Guide for Alzheimer’s Disease and Mild Cognitive Impairment (Version 2.0). CDISC, 2013.
19. Folstein MF, Robins LN, Helzer JE. The mini-mental state examination. Arch Gen Psychiatry 1983;40:812
22. Pfeffer RI, Kurosaki TT, Harrah CH Jr, Chance JM, Filos S. Measurement of functional activities in older adults in the community. J Gerontol 1982;37:323-329.
23. 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.
24. Yesavage JA, Brink TL, Rose TL, Lum O, Huang V, Adey M, et al. Development and validation of a geriatric depression screening scale: a preliminary report. J Psychiatr Res 1982;17:37-49.
25. Morris JC. The clinical dementia rating (CDR): current version and scoring rules. Neurology 1993;43:2412-2414.
26. Guy W. ECDEU assessment manual for psychopharmacology. Washington, DC: US Department of Health, Education, and Welfare; 1976.
27. Rosen WG, Terry RD, Fuld PA, Katzman R, Peck A. Pathological verification of ischemic score in differentiation of dementias. Ann Neurol 1980;7:486-488.
28. 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. Alzheimer Dis Assoc Disord 1997;11(Suppl 2):S33-S39.
30. Cano SJ, Posner HB, Moline ML, Hurt SW, Swartz J, Hsu T, et al. The ADAS-cog in Alzheimer’s disease clinical trials: psychometric evaluation of the sum and its parts. J Neurol Neurosurg Psychiatry 2010;81:1363-1368.
31. Gilman S, Koller M, Black RS, Jenkins L, Griffith SG, Fox NC, et al. Clinical effects of Abeta immunization (AN1792) in patients with AD in an interrupted trial. Neurology 2005;64:1553-1562.
33. 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;64:1323-1329.
34. Saxton J, McGonigle-Gibson KL, Swihart AA, Miller VJ, Boller F. Assessment of the severely impaired patient: description and validation of a new neuropsychological test battery. Psychol Assess 1990;2:298-303.
35. Moniz-Cook E, Vernooij-Dassen M, Woods R, Verhey F, Chattat R, De Vugt M, et al. A European consensus on outcome measures for psychosocial intervention research in dementia care. Aging Ment Health 2008;12:14-29.
36. 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.
37. Aisen PS, Cummings J, Doody R, Kramer L, Salloway S, Selkoe DJ, et al. The future of anti-amyloid trials. J Prev Alzheimers Dis 2020;7:146-151.
39. Reisberg B, Borenstein J, Salob SP, Ferris SH, Franssen E, Georgotas A. Behavioral symptoms in Alzheimer’s disease: phenomenology and treatment. J Clin Psychiatry 1987;48:9-15.
40. Ryu SH, Katona C, Rive B, Livingston G. Persistence of and changes in neuropsychiatric symptoms in Alzheimer disease over 6 months: the LASER-AD study. Am J Geriatr Psychiatry 2005;13:976-983.
41. Knopman DS, Knapp MJ, Gracon SI, Davis CS. The clinician interviewbased impression (CIBI): a clinician’s global change rating scale in Alzheimer’s disease. Neurology 1994;44:2315-2321.
42. Joffres C, Graham J, Rockwood K. Qualitative analysis of the clinician interview-based impression of change (plus): methodological issues and implications for clinical research. Int Psychogeriatr 2000;12:403-413.
43. Boothby H, Mann AH, Barker A. Factors determining interrater agreement with rating global change in dementia: the cibic‐plus. Int J Geriatr Psychiatry 1995;10:1037-1045.
44. Reisberg B. Global measures: utility in defining and measuring treatment response in dementia. Int Psychogeriatr 2007;19:421-456.
45. Schneider LS, Olin JT, Doody RS, Clark CM, Morris JC, Reisberg B, et al. Validity and reliability of the Alzheimer’s disease cooperative studyclinical global impression of change. Alzheimer Dis Assoc Disord 1997;11 Suppl 2:S22-S32.
46. Missotten P, Dupuis G, Adam S. Dementia-specific quality of life instruments: a conceptual analysis. Int Psychogeriatr 2016;28:1245-1262.
47. Coucill W, Bryan S, Bentham P, Buckley A, Laight A. EQ-5D in patients with dementia: an investigation of inter-rater agreement. Med Care 2001;39:760-771.