Responder analysis of a randomized comparison of the 13.3 mg/24 h and 9.5 mg/24 h rivastigmine patch

Alzheimer's Research & Therapy
José L MolinuevoChristine Strohmaier

Abstract

OPtimizing Transdermal Exelon In Mild-to-moderate Alzheimer's disease (OPTIMA) was a randomized, double-blind comparison of 13.3 mg/24 h versus 9.5 mg/24 h rivastigmine patch in patients with mild-to-moderate Alzheimer's disease who declined despite open-label treatment with 9.5 mg/24 h patch. Over 48 weeks of double-blind treatment, high-dose patch produced greater functional and cognitive benefits compared with 9.5 mg/24 h patch. Using OPTIMA data, a post-hoc responder analysis was performed to firstly, compare the proportion of patients demonstrating improvement or absence of decline with 13.3 mg/24 h versus 9.5 mg/24 h patch; and secondly, identify predictors of improvement or absence of decline. 'Improvers' were patients who improved on the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) by ≥4 points from baseline, and did not decline on the instrumental domain of the Alzheimer's Disease Cooperative Study-Activities of Daily Living scale (ADCS-IADL). 'Non-decliners' were patients who did not decline on either scale. Overall, 265 patients randomized to 13.3 mg/24 h and 271 to 9.5 mg/24 h patch met the criteria for inclusion in the intention-to-treat population and were included in the analyses. Significan...Continue Reading

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Citations

Feb 27, 2016·Expert Opinion on Pharmacotherapy·Rachel A NietoGeorge T Grossberg
Jun 3, 2015·Drugs & Aging·William James DeardorffGeorge T Grossberg
Aug 29, 2018·Suicide & Life-threatening Behavior·Brianna J TurnerKim L Gratz
Jan 1, 2015·Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova·E E Vasenina, O S Levin

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Clinical Trials Mentioned

NCT00506415

Software Mentioned

BL
DB
OPTIMA

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