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The Alzheimer's Disease Centers' Uniform Data Set (UDS) ORIGINAL ARTICLE The Alzheimer’s Disease Centers’ Uniform Data Set (UDS) The Neuropsychologic Test Battery Sandra Weintraub, PhD,* David Salmon, PhD,w Nathaniel Mercaldo, MS,z Steven Ferris, PhD,y Neill R. Graff-Radford, MD,J Helena Chui, MD,z Jeffrey Cummings, MD,# Charles DeCarli, MD, ** Norman L. Foster, MD, ww Douglas Galasko, MD,w Elaine Peskind, MD,zz Woodrow Dietrich, BS,z Duane L. Beekly, PhD,z Walter A. Kukull, PhD,z and John C. Morris, MDyy Key Words: aged, 80 and over, Alzheimer disease/diagnosis, data Abstract: The neuropsychologic test battery from the Uniform collection/method, cognition, Neuropsychologic Tests/standards, Data Set (UDS) of the Alzheimer’s Disease Centers (ADC) dementia program of the National Institute on Aging consists of brief measures of attention, processing speed, executive function, (Alzheimer Dis Assoc Disord 2009;23:91–101) episodic memory, and language. This paper describes development of the battery and preliminary data from the initial UDS evaluation of 3268 clinically cognitively normal men and women collected over the first 24 months of utilization. The subjects represent a europsychologic evaluation has played a central role in sample of community-dwelling, individuals who volunteer for Nthe clinical characterization of Alzheimer disease studies of cognitive aging. Subjects were considered ‘‘clinically (AD), its differentiation from ‘‘normal aging’’ and other cognitively normal’’ based on clinical assessment, including the Clinical Dementia Rating scale and the Functional Assessment forms of dementia, its staging over the course of illness, and Questionnaire. The results demonstrate performance on tests its response to cholinergic and other pharmacologic sensitive to cognitive aging and to the early stages of Alzheimer treatments. Neuropsychologic measures have been vali- disease in a relatively well-educated sample. Regression models dated against AD pathology1–12 and have been correlated investigating the impact of age, education, and sex on test scores with genetic risk factors and biomarkers of disease.1,2 The indicate that these variables will need to be incorporated in Alzheimer’s Disease Centers (ADC) program of the subsequent normative studies. Future plans include: (1) determin- National Institute on Aging (NIA) recently designed a ing the psychometric properties of the battery; (2) establishing neuropsychologic test battery as a component of the normative data, including norms for different ethnic minority Uniform Data Set (UDS), a systematic and centralized groups; and (3) conducting longitudinal studies on cognitively method of assessing patients and cognitively intact parti- normal subjects, individuals with mild cognitive impairment, and 13–15 individuals with Alzheimer disease and other forms of dementia. cipants at all contributing ADCs (N = 29). In existence since 1984, the ADC program has been highly successful in promoting research on AD, other dementias, and cognitive aging.16 In 1999, the first step was taken to standardize data collection across all ADCs by the establishment of the National Alzheimer’s Coordinating Received for publication February 18, 2008; accepted June 16, 2008. Center (NACC) and the development of the Minimum From the *Cognitive Neurology and Alzheimer’s Disease Center, Data Set. The Minimum Data Set consisted of a centralized Northwestern University Feinberg School of Medicine, Chicago, IL; wAlzheimer’s Disease Research Center, University of California catalog of clinical and demographic information on San Diego, San Diego, CA; zNational Alzheimer’s Coordinating participants (about 60 data elements), retrospectively Center, University of Washington; zzDepartment of Psychiatry and collected in the ADCs since their inception in 1984. It Behavioral Sciences, University of Washington School of Medicine largely served a registry function but, in combination with and VA Northwest Network Mental Illness, Research, Education and Clinical Center, Seattle WA; yAlzheimer’s Disease Center, New York the companion Neuropathology Data Set, could generate University School of Medicine, New York, NY; JMayo Clinic- and test clinico-pathologic correlation hypotheses. In 2002, Jacksonville, Jacksonville, FL; zHealth Consultation Center, Uni- the ADC Clinical Task Force (CTF) was established by versity of Southern California; #Katherine and Benjamin Kagan NIA with the mission of developing a set of standardized Alzheimer’s Disease Treatment Program, University of California Los Angeles, Los Angeles; **Alzheimer’s Disease Center, University evaluation and data collection procedures for all ADCs. of California Davis, Martinez, CA; wwDepartment of Neurology, The standardization of data collection and its annual Center for Alzheimer’s Care, Imaging and Research, University of schedule of follow-up were intended to provide a solid Utah, Salt Lake City, UT; and yyAlzheimer’s Disease Research platform for multicenter collaboration, enabling research Center, Washington University, St Louis, MO. Supported by National Institute on Aging (NIA) grant (U01 AG016976) on relatively large numbers of subjects, documenting to the National Alzheimer’s Coordinating Center, University of change over time, and helping to develop new research Washington, Seattle, WA. hypotheses. Reprints: Sandra Weintraub, PhD, Cognitive Neurology and Alzheimer’s The UDS gathers data annually from research Disease Center, Northwestern University Feinberg School of Medicine, 320 E. Superior, Searle 11-467, Chicago, IL 60611 (e-mail: participants on a total of 918 variables (20 administrative) [email protected]). relevant to the study of aging and dementia. These include Copyright r 2009 by Lippincott Williams & Wilkins demographics, features of symptom onset and course, Alzheimer Dis Assoc Disord Volume 23, Number 2, April–June 2009 www.alzheimerjournal.com | 91 Weintraub et al Alzheimer Dis Assoc Disord Volume 23, Number 2, April–June 2009 personal medical history, concurrent medications (363 burden for subjects and their study partners. Thus, with variables), family history of dementia, and performance input from the ADCs, the CTF concluded that the measures from neurologic and neuropsychologic examina- neuropsychologic battery should not add more than 30 tions.13 Data are collected from the participants and from minutes to existing protocols at each Center. One implica- their designated study partners by trained clinicians using tion of this principle was that tests already in use by all or structured interviews and objective test measures. Study most ADCs would be high on the list of candidates for partners provide subjective observations regarding partici- inclusion. pants’ cognitive function, behavior, and level of functional The CTF conducted several surveys of the ADCs to ability in activities of daily living, providing evidence for gather data about their ongoing assessment practices decline in these areas. including, among other variables: (1) cognitive domains Although ADCs also follow patients with non-AD tested; (2) specific instruments and versions, for tests with forms of dementia, the initial intent was to create a data multiple forms; (3) populations of subjects followed (ie, set focusing on the continuum from aging in cognitively disease and control groups; clinic and/or community normal controls, to mild cognitive impairment (MCI), to samples); and (4) frequency of subject visits. Once these early stages of AD. Subsequent expansions of the UDS data were acquired, the most commonly tested domains and are planned to also sample symptoms of vascular dementia, the most commonly used specific measures were identified dementia with Lewy bodies (DLB), behavioral variant and comments and approval were solicited from the ADCs. frontotemporal dementia, and primary progressive aphasia. The purpose of the present paper is to describe the Methods for Standardizing Administration development of the neuropsychologic test battery compo- and Scoring nent of the UDS and to present initial descriptive data from Individuals who conduct the cognitive battery differ 3268 participants determined to be ‘‘clinically cognitively across ADCs and may include physicians, neuropsycholo- normal,’’ collected in the first 24 months after implementa- gists, neuropsychology technicians, research coordinators, tion of the UDS in September 2005. and nurses. A number of steps were taken to assure standardization of test administration and scoring. First, a detailed manual of administration and scoring instructions METHODS was designed (UDS Guidebook and Appendix, the latter replaced in Version 2.0 with the Neuropsychological Test Rationale and Procedures for Selection Instructions), distributed to the ADCs for comments, of Cognitive Domains revised on the basis of feedback, and disseminated. A Cognitive domain and test selection were based on a meeting was held in November 2005, after several months combination of methods evolving from regular meetings of of pilot testing, to train individuals who administer and the CTF. A subcommittee was formed to specifically score the tests at each ADC. At the meeting, each item of undertake the design of the neuropsychologic test battery, the testing was reviewed and questions and answers about to bring essential issues to the larger group and to interface the instructions were discussed. On the basis of this with the ADCs. Three overriding criteria governed deci- meeting, possible revisions to the UDS neuropsychologic sions for selecting domains and tests. The first was
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