TY - JOUR
T1 - A multicenter evaluation of new treatment efficacy instruments for Alzheimer's disease clinical trials
T2 - Overview and general results
AU - Ferris, Steven H.
AU - Mackell, Joan A.
AU - Mohs, Richard
AU - Schneider, Lon S.
AU - Galasko, Douglas
AU - Whitehouse, Peter J.
AU - Schmitt, Frederick A.
AU - Sano, Mary
AU - Thomas, Ronald G.
AU - Ernesto, Christopher
AU - Grundman, Michael
AU - Schafer, Kimberly
AU - Thal, Leon J.
PY - 1997
Y1 - 1997
N2 - Evaluating treatment efficacy in Alzheimer's disease (AD) clinical trials requires optimal assessment methods to determine the extent and clinical meaningfulness of potential therapeutic effects of pharmacologic agents. Development of improved outcome measures for AD clinical trials is a major objective of the Alzheimer's Disease Cooperative Study (ADCS), an NIA-sponsored, multisite clinical trials consortium. The ADCS Instrument Development Project evaluated the sensitivity, reliability and validity of new or improved measures in each of five assessment domains: (a) cognition (immediate and delayed memory, praxis, attention, and executive function); (b) clinical global change; (c) activities of daily living; (d) behavioral symptoms (agitation and other noncognitive symptoms); and (e) cognition in severely impaired patients. A total of 306 English-speaking subjects were enrolled in the study, including AD patients stratified by disease severity and cognitively normal, age-matched elderly subjects. Half were retested at 1 month and 2 months after baseline, and all received 6- and 12-month follow-up assessments. Spanish versions of these new measures are currently being evaluated. The development of this multisite study, the common methods and procedures, and a detailed description of the cohort are provided in this overview article. This multisite project demonstrates the feasibility of a consortium approach to instrument development. We were able to develop new instruments and efficiently evaluate their reliability and sensitivity to longitudinal change by capitalizing on the experience and patient resources of the participating ADCS research sites.
AB - Evaluating treatment efficacy in Alzheimer's disease (AD) clinical trials requires optimal assessment methods to determine the extent and clinical meaningfulness of potential therapeutic effects of pharmacologic agents. Development of improved outcome measures for AD clinical trials is a major objective of the Alzheimer's Disease Cooperative Study (ADCS), an NIA-sponsored, multisite clinical trials consortium. The ADCS Instrument Development Project evaluated the sensitivity, reliability and validity of new or improved measures in each of five assessment domains: (a) cognition (immediate and delayed memory, praxis, attention, and executive function); (b) clinical global change; (c) activities of daily living; (d) behavioral symptoms (agitation and other noncognitive symptoms); and (e) cognition in severely impaired patients. A total of 306 English-speaking subjects were enrolled in the study, including AD patients stratified by disease severity and cognitively normal, age-matched elderly subjects. Half were retested at 1 month and 2 months after baseline, and all received 6- and 12-month follow-up assessments. Spanish versions of these new measures are currently being evaluated. The development of this multisite study, the common methods and procedures, and a detailed description of the cohort are provided in this overview article. This multisite project demonstrates the feasibility of a consortium approach to instrument development. We were able to develop new instruments and efficiently evaluate their reliability and sensitivity to longitudinal change by capitalizing on the experience and patient resources of the participating ADCS research sites.
KW - ADCS
KW - Alzheimer's disease
KW - Instrument development
KW - Longitudinal change
KW - Multisite clinical trials
KW - Outcome measures
UR - http://www.scopus.com/inward/record.url?scp=0030819805&partnerID=8YFLogxK
M3 - Article
C2 - 9236947
AN - SCOPUS:0030819805
SN - 0893-0341
VL - 11
SP - S1-S12
JO - Alzheimer Disease and Associated Disorders
JF - Alzheimer Disease and Associated Disorders
IS - SUPPL. 2
ER -