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

Alzheimers Res Ther. 2016 Feb 22;8:9. doi: 10.1186/s13195-016-0176-z.

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.

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Aged
  • Alzheimer Disease / diagnosis*
  • Alzheimer Disease / psychology*
  • Clinical Trials as Topic
  • Cognition
  • Cognitive Dysfunction / diagnosis*
  • Cognitive Dysfunction / psychology*
  • Female
  • Humans
  • Male
  • Memory
  • Mental Status Schedule*
  • Neuropsychological Tests*
  • Psychometrics
  • ROC Curve