title: Mini Mental State Examination and Logical Memory scores for entry into Alzheimer's disease trials.
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.
authors.affiliation: Boston University Alzheimer's Disease and CTE Center, 72 East Concord Street, Suite B7800, Boston, MA, 02118, USA. kchap@bu.edu.
authors.forename: Kimberly R
authors.initials: KR
authors.lastname: Chapman
authors.affiliation: Boston University Alzheimer's Disease and CTE Center, 72 East Concord Street, Suite B7800, Boston, MA, 02118, USA. hbingcan@bu.edu.
authors.forename: Hanaan
authors.initials: H
authors.lastname: Bing-Canar
authors.affiliation: Boston University Alzheimer's Disease and CTE Center, 72 East Concord Street, Suite B7800, Boston, MA, 02118, USA. malosco@bu.edu.|Department of Neurology, Boston University School of Medicine, Boston, MA, 02118, USA. malosco@bu.edu.
authors.forename: Michael L
authors.initials: ML
authors.lastname: Alosco
authors.affiliation: Boston University Alzheimer's Disease and CTE Center, 72 East Concord Street, Suite B7800, Boston, MA, 02118, USA. egstein@bu.edu.
authors.forename: Eric G
authors.initials: EG
authors.lastname: Steinberg
authors.affiliation: Boston University Alzheimer's Disease and CTE Center, 72 East Concord Street, Suite B7800, Boston, MA, 02118, USA. brmartin@bu.edu.|Data Coordinating Center, Boston University School of Public Health, Boston, MA, 02118, USA. brmartin@bu.edu.
authors.forename: Brett
authors.initials: B
authors.lastname: Martin
authors.affiliation: Boston University Alzheimer's Disease and CTE Center, 72 East Concord Street, Suite B7800, Boston, MA, 02118, USA. chaisson@bu.edu.|Data Coordinating Center, Boston University School of Public Health, Boston, MA, 02118, USA. chaisson@bu.edu.|Department of Biostatistics, Boston University School of Public Health, Boston, MA, 02118, USA. chaisson@bu.edu.
authors.forename: Christine
authors.initials: C
authors.lastname: Chaisson
authors.affiliation: Boston University Alzheimer's Disease and CTE Center, 72 East Concord Street, Suite B7800, Boston, MA, 02118, USA. nkowall@bu.edu.|Department of Neurology, Boston University School of Medicine, Boston, MA, 02118, USA. nkowall@bu.edu.|Department of Pathology, Boston University School of Medicine, Boston, MA, 02118, USA. nkowall@bu.edu.|Neurology Service, VA Boston Healthcare System, Boston, MA, 02130, USA. nkowall@bu.edu.
authors.forename: Neil
authors.initials: N
authors.lastname: Kowall
authors.affiliation: Boston University Alzheimer's Disease and CTE Center, 72 East Concord Street, Suite B7800, Boston, MA, 02118, USA. yorghos@bu.edu.|Department of Biostatistics, Boston University School of Public Health, Boston, MA, 02118, USA. yorghos@bu.edu.
authors.forename: Yorghos
authors.initials: Y
authors.lastname: Tripodis
authors.affiliation: Boston University Alzheimer's Disease and CTE Center, 72 East Concord Street, Suite B7800, Boston, MA, 02118, USA. bobstern@bu.edu.|Department of Neurology, Boston University School of Medicine, Boston, MA, 02118, USA. bobstern@bu.edu.|Department of Neurosurgery, Boston University School of Medicine, Boston, MA, 02118, USA. bobstern@bu.edu.|Department of Anatomy & Neurobiology, Boston University School of Medicine, Boston, MA, 02118, USA. bobstern@bu.edu.
authors.forename: Robert A
authors.initials: RA
authors.lastname: Stern
mesh_terms: D000368:Aged; D000544:Alzheimer Disease / Q000175:diagnosis* / Q000523:psychology*; D002986:Clinical Trials as Topic; D003071:Cognition; D060825:Cognitive Dysfunction / Q000175:diagnosis* / Q000523:psychology*; D005260:Female; D006801:Humans; D008297:Male; D008568:Memory; D008609:Mental Status Schedule; D009483:Neuropsychological Tests; D011594:Psychometrics; D012372:ROC Curve