Effects of rivastigmine transdermal patch and capsule on aspects of clinical global impression of change in Alzheimer's disease: a retrospective analysis.
BACKGROUND
The Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) scale is widely used in Alzheimer trials. It assesses cognition, activities of daily living (ADLs), behavior and global functioning. To advance the understanding of relationships between the ADCS-CGIC and scores from other commonly used tools, this analysis investigated the ability of each domain to measure change. This was a hypothesis-forming study, designed to provide a basis for possible future research.


METHODS
This retrospective analysis used data from a 24-week, randomized, placebo-controlled trial [study ENA713D2320 (IDEAL)] that evaluated rivastigmine patches and capsules in AD patients.


RESULTS
At week 24, significant treatment effects versus placebo were seen on the ADCS-CGIC cognitive domain with rivastigmine 17.4 mg/24 h patch (p < 0.01), 9.5 mg/24 h patch (p = 0.02) and capsules (p < 0.01); similarly on the ADCS-CGIC ADL domain. The cognition portion of the CGIC correlated with the Alzheimer's Disease Assessment Scale cognitive subscale and the ADL section with the ADCS-ADL trial measures. Variance ascribable to these tools was small, indicating that CGIC detects changes not measured by the domain-specific tools.


CONCLUSIONS
The results of this post hoc analysis suggest that the ADCS-CGIC accurately reflects changes in cognitive and functional domains measured by other tools; it captures changes not assessed by domain-specific instruments. Cognitive alterations show greatest correlation with total CGIC. These results may assist in analyzing and interpreting CGIC results in other trials.
Cummings
Jeffrey L
JL
Mary S. Easton Center for Alzheimer's Disease Research at UCLA, Los Angeles, CA 90095-7226, USA. jcummings@mednet.ucla.edu
Ferris
Steven H
SH
Farlow
Martin R
MR
Olin
Jason T
JT
Meng
Xiangyi
X
D000279:Administration, Cutaneous; D000284:Administration, Oral; D000368:Aged; D000369:Aged, 80 and over; D000544:Alzheimer Disease / Q000188:drug therapy* / Q000523:psychology*; D001519:Behavior; D002214:Capsules; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008606:Mental Processes; D008875:Middle Aged; D018696:Neuroprotective Agents / Q000008:administration & dosage* / Q000627:therapeutic use*; D009483:Neuropsychological Tests; D048448:Phenylcarbamates / Q000008:administration & dosage* / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D012189:Retrospective Studies; D000068836:Rivastigmine; D016896:Treatment Outcome
D002214:Capsules; D018696:Neuroprotective Agents; D048448:Phenylcarbamates; D000068836:Rivastigmine