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Am J Alzheimers Dis Other Demen. 2010 Mar;25(2):119-24. doi: 10.1177/1533317509350298.

Item analysis of ADAS-Cog: effect of baseline cognitive impairment in a clinical AD trial.

Author information

1
Merck Research Laboratories, North Wales, PA, USA. jeffrey.sevigny@novartis.com

Abstract

We explored the association of Alzheimer's disease (AD) Assessment Scale (ADAS-Cog) item scores with AD severity using cross-sectional and longitudinal data from the same study. Post hoc analyses were performed using placebo data from a 12-month trial of patients with mild-to-moderate AD (N =281 randomized, N =209 completed). Baseline distributions of ADAS-Cog item scores by Mini-Mental State Examination (MMSE) score and Clinical Dementia Rating (CDR) sum of boxes score (measures of dementia severity) were estimated using local and nonparametric regressions. Mixed-effect models were used to characterize ADAS-Cog item score changes over time by dementia severity (MMSE: mild =21-26, moderate =14-20; global CDR: mild =0.5-1, moderate =2). In the cross-sectional analysis of baseline ADAS-Cog item scores, orientation was the most sensitive item to differentiate patients across levels of cognitive impairment. Several items showed a ceiling effect, particularly in milder AD. In the longitudinal analysis of change scores over 12 months, orientation was the only item with noticeable decline (8%-10%) in mild AD. Most items showed modest declines (5%-20%) in moderate AD.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00074529.

PMID:
19949163
DOI:
10.1177/1533317509350298
[Indexed for MEDLINE]
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