Predictors of Placebo Group Decline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) in 24 Week Clinical Trials of Alzheimer's Disease
| Autor: | Robert Lai, Chanchal Bains, Steven J. Barrett, Gareth Maher-Edwards, John G. Weil, Janette P. Laroche, David J. Webb, David A. Hosford, Michael C. Irizarry |
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| Rok vydání: | 2008 |
| Předmět: |
Male
medicine.medical_specialty Vasodilator Agents Neuropsychological Tests Placebo Severity of Illness Index behavioral disciplines and activities law.invention Rosiglitazone Double-Blind Method Randomized controlled trial Alzheimer Disease Predictive Value of Tests Risk Factors law Internal medicine mental disorders Severity of illness medicine Humans Prospective Studies Cognitive decline Prospective cohort study Aged business.industry General Neuroscience Cognition General Medicine Clinical trial Psychiatry and Mental health Clinical Psychology Predictive value of tests Physical therapy Female Thiazolidinediones Geriatrics and Gerontology Cognition Disorders business human activities |
| Zdroj: | Journal of Alzheimer's Disease. 14:301-311 |
| ISSN: | 1875-8908 1387-2877 |
| DOI: | 10.3233/jad-2008-14304 |
| Popis: | One limitation of several recent 24 week Alzheimer's disease (AD) clinical trials was the lack of cognitive decline detected by the AD Assessment Scale-cognitive subscale (ADAS-cog) in the placebo groups, possibly obscuring true medication effects. Data from 733 individuals in the placebo arms of six AD clinical trials performed 1996-1997 were pooled to examine the relationship of clinical, demographic, and genetic characteristics with the 24 week change in ADAS-cog. Baseline cognitive and functional status and the screening-to-baseline change in ADAS-cog were the strongest independent predictors of the 24 week change in ADAS-cog. The ADAS-cog did not detect progression in patients with mild dementia (screening Mini-Mental State Exam, MMSE, >or=20). The change in ADAS-cog from screening to baseline was inversely correlated with the 24 week change score; it was more difficult to detect cognitive decline at 24 weeks if individuals markedly worsened from screening to baseline. The effects of baseline MMSE and screening-to-baseline change in ADAS-cog generalized to the placebo group (N=106) of another AD study performed in 2004-2005. Overcoming lack of placebo decline in AD clinical trials will require scales more sensitive to cognitive decline in mild AD and strategies to reduce within-person variability in outcome measures. |
| Databáze: | OpenAIRE |
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