A Brief Report on the Appropriateness of the MMSE score as an 
   Lead Investigator:    Kimberly Chapman
   Institution      :    Boston University
   E-Mail           :    kchap@bu.edu
   Proposal ID      :    606


   Publications:


1  Chapman KR, Bing-Canar H, Alosco ML, Steinberg EG, Martin, B, Chaisson C, Kowall N, Triposdis Y, Stern RA
   Mini Mental State Examination and logical Memory scores for entry into Alzheimer's disease trials
   Journal Article  Alzheimers Res Ther,8:9,2016,PMC4762168

   PUBLISHED





   Proposal Description:
   The large majority of Alzheimer???s disease clinical trials use the MMSE score    for inclusion criteria. This is problematic as the MMSE has many limitations,     including large ceiling and floor effects, practice effects, as well as other     psychometric limitations (e.g., inadequate assessment of memory, absence of       executive function items) that may inaccurately characterize the cognitive        status of the participant. Consequently, it is possible that individuals who      are cognitively intact can score within the impaired range on the test (due to    low education, etc), making them eligible for clinical trials that may not be     appropriate for them based on their cognitively healthy status. Conversely,       some individuals who are cognitively impaired and received a diagnosis of MCI     or Alzheimer???s disease (particularly mild AD) may not be eligible for           clinical trials because they have scored relatively well (above the cut-off on    the MMSE) due to factors such as high education. Taken together, due to the use                                                                                   of the MMSE for inclusion into AD clinical trials, it is likely that many         individuals are being included in these high profile and methodologically         rigorous clinical trial studies that may not be appropriate.                                                                                                        The proposed study will first describe the extent and nature of the use of the    MMSE for inclusion/exclusion criteria in current clinical trials for              Alzheimer???s disease. This study will review the psychometric properties and     limitations of the MMSE and then exploit the data from the BU ADC to              demonstrate the inadequacies of the MMSE to support our hypothesis that the       MMSE is not an appropriate tool for determining entry into AD clinical trials.