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Confirmatory cognitive tests aid early Alzheimer

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Area of Science:

  • Neuroscience
  • Clinical Trials
  • Cognitive Assessment

Background:

  • Confirmatory cognitive tests like the FCSRT, RBANS, and Wechsler Memory Scale (WMS)-Logical Memory II are crucial for screening in early Alzheimer's Disease (AD) clinical trials.
  • These instruments ensure participants have objectifiable cognitive decline but can be lengthy and burdensome for participants and raters.
  • This analysis evaluates their utility and added value beyond the Mini-Mental State Examination (MMSE) in early AD screening.

Purpose of the Study:

  • To assess the effectiveness of FCSRT, RBANS, and WMS-LMII in screening participants for early Alzheimer's Disease clinical trials.
  • To determine the added value of these instruments on top of Mini-Mental State Examination (MMSE) inclusion criteria.
  • To compare the performance of different cognitive tests in identifying ineligible subjects.

Main Methods:

  • Analysis of data from 5 large clinical trials in early Alzheimer's Disease.
  • Utilized descriptive statistics and logistic regression models.
  • Tested the performance of FCSRT, RBANS, and WMS-LMII against MMSE scores to exclude unsuitable subjects.

Main Results:

  • RBANS, FCSRT, and WMS-LMII identified 23-37% of subjects meeting MMSE criteria as ineligible.
  • All instruments screened out over 50% of subjects with an MMSE score of 30.
  • Performance varied significantly by MMSE score, with FCSRT and WMS-LMII showing linear performance, while RBANS demonstrated curvilinear performance, especially for MMSE scores below 25.

Conclusions:

  • Confirmatory cognitive tests effectively screen out subjects lacking objectifiable cognitive decline in early AD trials.
  • Significant performance differences exist between FCSRT, RBANS, and WMS-LMII, particularly for participants with lower MMSE scores.
  • Clinical trial designers should consider these performance variations, subject/rater burden, and trial objectives when selecting screening instruments.