PMID- 17760991
OWN - NLM
STAT- MEDLINE
DCOM- 20071107
LR  - 20220408
IS  - 1471-2377 (Electronic)
IS  - 1471-2377 (Linking)
VI  - 7
DP  - 2007 Aug 30
TI  - The clinical meaningfulness of ADAS-Cog changes in Alzheimer's disease patients 
      treated with donepezil in an open-label trial.
PG  - 26
AB  - BACKGROUND: In 6-month anti-dementia drug trials, a 4-point change in the 
      Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) is held to be 
      clinically important. We examined how this change compared with measures of 
      clinical meaningfulness. METHODS: This is a secondary analysis of a 12 month 
      open-label study of 100 patients (71 women) diagnosed with mild to moderate AD 
      treated with 5-10 mg of donepezil daily. We studied the observed case, 6-month 
      change from baseline on the ADAS-Cog, the Clinician's Interview Based Impression 
      of Change-Plus Caregiver Input (CIBIC-Plus), patient-Goal Attainment Scaling 
      (PGAS) and clinician-GAS (CGAS). RESULTS: At 6 months, donepezil-treated patients 
      (n = 95) were more likely to show no change (+/- 3 points) on the ADAS-Cog (56%) 
      than to improve (20%) or decline (24%) by 4-points. ADAS-Cog change scores were 
      little correlated with other measures: from -0.09 for PGAS to 0.27 for the 
      CIBIC-Plus. While patients who improved on the ADAS-Cog were less likely to 
      decline on the clinical measures (26%), 43% of patients who declined on the 
      ADAS-Cog improved on at least two of the clinical measures. CONCLUSION: The 
      ADAS-Cog did not capture all clinically important effects. In general, ADAS-Cog 
      improvement indicates clinical improvement, whereas many people with ADAS-Cog 
      decline do not show clinical decline. The open-label design of this study does 
      not allow us to know whether this is a treatment effect, which requires further 
      investigation.
FAU - Rockwood, Kenneth
AU  - Rockwood K
AD  - Division of Geriatric Medicine, Department of Medicine, Dalhousie University, 
      Halifax, Canada. Kenneth.Rockwood@Dal.ca
FAU - Fay, Sherri
AU  - Fay S
FAU - Gorman, Mary
AU  - Gorman M
FAU - Carver, Daniel
AU  - Carver D
FAU - Graham, Janice E
AU  - Graham JE
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20070830
PL  - England
TA  - BMC Neurol
JT  - BMC neurology
JID - 100968555
RN  - 0 (Cholinesterase Inhibitors)
RN  - 0 (Indans)
RN  - 0 (Nootropic Agents)
RN  - 0 (Piperidines)
RN  - 8SSC91326P (Donepezil)
SB  - IM
MH  - Activities of Daily Living
MH  - Aged
MH  - Aged, 80 and over
MH  - Alzheimer Disease/*drug therapy/psychology
MH  - Cholinesterase Inhibitors/*therapeutic use
MH  - Clinical Trials as Topic/statistics & numerical data
MH  - Donepezil
MH  - Female
MH  - Humans
MH  - Indans/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Nootropic Agents/*therapeutic use
MH  - Piperidines/*therapeutic use
MH  - *Severity of Illness Index
MH  - Treatment Outcome
PMC - PMC2034585
EDAT- 2007/09/01 09:00
MHDA- 2007/11/08 09:00
PMCR- 2007/08/30
CRDT- 2007/09/01 09:00
PHST- 2006/11/01 00:00 [received]
PHST- 2007/08/30 00:00 [accepted]
PHST- 2007/09/01 09:00 [pubmed]
PHST- 2007/11/08 09:00 [medline]
PHST- 2007/09/01 09:00 [entrez]
PHST- 2007/08/30 00:00 [pmc-release]
AID - 1471-2377-7-26 [pii]
AID - 10.1186/1471-2377-7-26 [doi]
PST - epublish
SO  - BMC Neurol. 2007 Aug 30;7:26. doi: 10.1186/1471-2377-7-26.