Using baseline cognitive severity for enriching Alzheimer's disease clinical trials: How does Mini-Mental State Examination predict rate of change?

Richard E. Kennedy, Gary R. Cutter, Guoqiao Wang, Lon S. Schneider

Research output: Contribution to journalArticlepeer-review

21 Scopus citations

Abstract

Background Post hoc analyses from clinical trials in Alzheimer's disease (AD) suggest that more cognitively impaired participants respond differently from less impaired on cognitive outcomes. We examined pooled clinical trials data to assess the utility of enriching trials using baseline cognition. Methods We included 2882 participants with mild to moderate AD in seven studies from a meta-database. We used mixed effects models to estimate the rate of decline in Alzheimer's disease Assessment Scale-cognitive (ADAS-Cog) scores among Mini-Mental State Examination (MMSE) groups. Findings Baseline MMSE category was associated with baseline scores and rate of decline on the ADAS-Cog, adjusting for age and education (both P <.001). Greater baseline cognitive impairment was associated with more rapid progression. Interpretations Although we found significant differences in rate of decline, most differences between individuals were from baseline ADAS-Cog values. Since enrichment based on MMSE would reduce the recruitment pool while adding only slightly to detecting differences in rate of progression, it is not advised.

Original languageEnglish
Pages (from-to)46-52
Number of pages7
JournalAlzheimer's and Dementia: Translational Research and Clinical Interventions
Volume1
Issue number1
DOIs
StatePublished - Oct 14 2015

Keywords

  • Alzheimer disease
  • Alzheimer's Disease Assessment Scale
  • Alzheimer's Disease Cooperative study (ADCS)
  • Alzheimer's Disease Neuroimaging Initiative (ADNI)
  • Clinical trials
  • Clinical trials and methods
  • Mini-Mental State Examination
  • Simulations

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