Mini Mental State Examination and Logical Memory scores for entry into Alzheimer’s disease trials

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Abstract

Background

Specific cutoff scores on the Mini Mental State Examination (MMSE) and the Logical Memory (LM) test are used to determine inclusion in Alzheimer’s disease (AD) clinical trials and diagnostic studies. These screening measures have known psychometric limitations, but no study has examined the diagnostic accuracy of the cutoff scores used to determine entry into AD clinical trials and diagnostic studies.

Methods

ClinicalTrials.gov entries were reviewed for phases II and III active and recruiting AD studies using the MMSE and LM for inclusion. The diagnostic accuracy of MMSE and LM-II cutoffs used in AD trials and diagnostic studies was examined using 23,438 subjects with normal cognition, mild cognitive impairment (MCI), and AD dementia derived from the National Alzheimer’s Coordinating Center database.

Results

MMSE and LM cutoffs used in current AD clinical trials and diagnostic studies had limited diagnostic accuracy, particularly for distinguishing between normal cognition and MCI, and MCI from AD dementia. The MMSE poorly discriminated dementia stage.

Conclusions

The MMSE and LM may result in inappropriate subject enrollment in large-scale, multicenter studies designed to develop therapeutics and diagnostic methods for AD.

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Most cited references 21

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The Alzheimer's Disease Centers' Uniform Data Set (UDS): the neuropsychologic test battery.

Sandra Weintraub, David Salmon, Nathaniel Mercaldo … (2009)

The neuropsychologic test battery from the Uniform Data Set (UDS) of the Alzheimer's Disease Centers (ADC) program of the National Institute on Aging consists of brief measures of attention, processing speed, executive function, 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 sample of community-dwelling, individuals who volunteer for studies of cognitive aging. Subjects were considered "clinically cognitively normal" based on clinical assessment, including the Clinical Dementia Rating scale and the Functional Assessment Questionnaire. The results demonstrate performance on tests sensitive to cognitive aging and to the early stages of Alzheimer disease in a relatively well-educated sample. Regression models investigating the impact of age, education, and sex on test scores indicate that these variables will need to be incorporated in subsequent normative studies. Future plans include: (1) determining the psychometric properties of the battery; (2) establishing normative data, including norms for different ethnic minority groups; and (3) conducting longitudinal studies on cognitively normal subjects, individuals with mild cognitive impairment, and individuals with Alzheimer disease and other forms of dementia.

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Clinical dementia rating: a reliable and valid diagnostic and staging measure for dementia of the Alzheimer type.

J Morris (1997)

Global staging measures for dementia of the Alzheimer type (DAT) assess the influence of cognitive loss on the ability to conduct everyday activities and represent the "ultimate test" of efficacy for antidementia drug trials. They provide information about clinically meaningful function and behavior and are less affected by the "floor" and "ceiling" effects commonly associated with psychometric tests. The Washington University Clinical Dementia Rating (CDR) is a global scale developed to clinically denote the presence of DAT and stage its severity. The clinical protocol incorporates semistructured interviews with the patient and informant to obtain information necessary to rate the subject's cognitive performance in six domains: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. The CDR has been standardized for multicenter use, including the Consortium to Establish a Registry for Alzheimer's Disease (CERAD) and the Alzheimer's Disease Cooperative Study, and interrater reliability has been established. Criterion validity for both the global CDR and scores on individual domains has been demonstrated, and the CDR also has been validated neuropathologically, particularly for the presence or absence of dementia. Standardized training protocols are available. Although not well suited as a brief screening tool for population surveys of dementia because the protocol depends on sufficient time to conduct interviews, the CDR has become widely accepted in the clinical setting as a reliable and valid global assessment measure for DAT.

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The National Alzheimer's Coordinating Center (NACC) Database: an Alzheimer disease database.

Duane L Beekly, Erin Ramos, Gerald van Belle … (2015)

The National Alzheimer's Coordinating Center (NACC) is responsible for developing and maintaining a database of patient information collected from the 29 Alzheimer disease centers (ADCs) funded by the National Institute on Aging. Each of the centers collects center-determined data elements on patients enrolled into its center and transmits a minimum dataset to NACC. Data are managed differently at each center depending on that center's research needs. The centers' data systems vary from a single personal computer running spreadsheet software to a network of servers running an advanced data management system such as Oracle. The challenge for NACC is to expand and adjust previously collected data elements into an integrated database that could be used for administrative as well as research purposes. In addition, NACC sought to allow the centers to have the flexibility they needed for data submission. To accomplish this task, NACC designed a database that contained separate specific datasets each with individual data elements. NACC also designed a data management system to easily collect and manage these data. The NACC web site (www.alz.washington.edu) was created to allow access to the data.

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Author and article information

Contributors

Kimberly R. Chapman: kchap@bu.edu

Hanaan Bing-Canar: hbingcan@bu.edu

Michael L. Alosco: malosco@bu.edu

Eric G. Steinberg: egstein@bu.edu

Brett Martin: brmartin@bu.edu

Christine Chaisson: chaisson@bu.edu

Neil Kowall: nkowall@bu.edu

Yorghos Tripodis: yorghos@bu.edu

Robert A. Stern:

ORCID: http://orcid.org/0000-0002-5008-077X

617-638-5678 , bobstern@bu.edu

Journal

Journal ID (nlm-ta): Alzheimers Res Ther

Journal ID (iso-abbrev): Alzheimers Res Ther

Title: Alzheimer's Research & Therapy

Publisher: BioMed Central (London )

ISSN (Electronic): 1758-9193

Publication date (Electronic): 22 February 2016

Publication date PMC-release: 22 February 2016

Publication date Collection: 2016

Volume: 8

Electronic Location Identifier: 9

Affiliations

[ ]Boston University Alzheimer’s Disease and CTE Center, 72 East Concord Street, Suite B7800, Boston, MA 02118 USA

[ ]Department of Neurology, Boston University School of Medicine, Boston, MA 02118 USA

[ ]Data Coordinating Center, Boston University School of Public Health, Boston, MA 02118 USA

[ ]Department of Biostatistics, Boston University School of Public Health, Boston, MA 02118 USA

[ ]Department of Pathology, Boston University School of Medicine, Boston, MA 02118 USA

[ ]Neurology Service, VA Boston Healthcare System, Boston, MA 02130 USA

[ ]Department of Neurosurgery, Boston University School of Medicine, Boston, MA 02118 USA

[ ]Department of Anatomy & Neurobiology, Boston University School of Medicine, Boston, MA 02118 USA

Author information

Robert A. Stern http://orcid.org/0000-0002-5008-077X

Article

Publisher ID: 176

DOI: 10.1186/s13195-016-0176-z

PMC ID: 4762168

PubMed ID: 26899835

SO-VID: b3839733-5af3-4c3b-892f-987c5849bf49

License:

Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

History

Date received : 21 December 2015

Date accepted : 13 January 2016

Funding

Funded by: NIA/NIH

Award ID: U01 AG016976

Funded by: NIA

Award ID: P30 AG013846

Custom metadata

ScienceOpen disciplines: Neurology

Keywords: alzheimer’s disease,clinical trials,mmse,logical memory,eligibility,mild cognitive impairment,neurodegenerative disease

Data availability:

ScienceOpen disciplines: Neurology

Keywords: alzheimer’s disease, clinical trials, mmse, logical memory, eligibility, mild cognitive impairment, neurodegenerative disease

Mini Mental State Examination and Logical Memory scores for entry into Alzheimer’s disease trials

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Most cited references 21

The Alzheimer's Disease Centers' Uniform Data Set (UDS): the neuropsychologic test battery.

Clinical dementia rating: a reliable and valid diagnostic and staging measure for dementia of the Alzheimer type.

The National Alzheimer's Coordinating Center (NACC) Database: an Alzheimer disease database.

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