Article Text

PDF
Abstracts from the Association of British Neurologists Annual Meeting 2011
024 What is the clinically relevant change on the ADAS-cog?
  1. J Schott,
  2. A Schrag
  1. Institute of Neurology, UCL

Abstract

Background The ADAS-Cog is a principal outcome measure for clinical trials of Alzheimer's disease (AD). To date decisions on how much change in ADAS-Cog score is clinically relevant has been based on consensus opinion. We aimed to use statistical methodology to establish the minimal clinically relevant change (MCRC) on the ADAS-Cog for patients with mild AD.

Methods We analysed data from the Alzheimer's disease Neuroimaging Initiative. We applied anchor-based MCRC methodology comparing ADAS-cog change against clinicians’ judgement of clinically relevant change between baseline and 6 months in four domains: memory and non-memory cognitive performance; Clinical Dementia Rating Scale; and Functional Assessment Questionnaire. The analysis was repeated for the 6–12 month interval. To support these findings, we calculated distribution-based measures including half-baseline SD (1/2SD) and SE of measurement (SEM).

Results 181 patients (baseline ADAS-Cog score 18.5±6.4) had ADAS-Cog data at 0 and 6 months. Those undergoing clinically significant change on any of the four anchor questions (n=41–47) had an average ADAS-Cog change of 3.1–3.8 points. Similar results were found for the 177 patients with 6–12 month data. The average 1/2SD for the baseline ADAS-cog score was 3.2, and SEM was 3.7.

Conclusions These data support three point change on the ADAS-Cog as being an appropriate MCRC for clinical trials of patients with early AD.

Statistics from Altmetric.com

Footnotes

  • Email: jschott{at}dementia.ion.ucl.ac.uk

Request permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.