Alzheimer’s disease (AD) is characterized by progressive impairments in cognition and ability to perform activities of daily living (ADL). Instrumental ADL (IADL) require complex thinking to perform, and are generally impaired early in the disease course. This was an exploratory analysis of data from a 48-week, randomized, double-blind trial of 9.5 mg/24 h and 13.3 mg/24 h rivastigmine patch in patients with AD who had demonstrated functional and cognitive decline during open-label treatment with 9.5 mg/24 h patch. The change from double-blind baseline at Week 48 on the AD Cooperative Study–IADL (ADCS-IADL) scale was calculated overall (co-primary outcome) and for individual items, and compared (13.3 versus 9.5 mg/24 h patch). Of 1584 patients enrolled into the initial open-label phase, 567 were randomized (13.3 mg/24 h, N=280; 9.5 mg/24 h patch, N=287). The mean change from baseline on the ADCS-IADL was statistically superior with 13.3 mg/24 h patch from Week 16 onwards (p below 0.05). When individual ADCS-IADL item scores were compared, although between-group differences were slight, suggesting a cumulative effect, patients receiving 13.3 mg/24 h patch experienced numerically less decline from baseline on all 17 items compared with 9.5 mg/24 h patch. The 13.3 mg/24 h patch significantly reduced deterioration in IADL compared with 9.5 mg/24 h patch in this patient population. Less decline was observed with 13.3 versus 9.5 mg/24 h patch on all individual items, including those supporting social interactions and independence. These results indicate high-dose rivastigmine patch offers clinically meaningful benefits for patients and caregivers on key ADL.
Jeffrey Cummings, MD; George Grossberg, MD; Gustavo Alva, MD; Angelika Caputo, PhD; Pamela Downs, BSc; Christine Strohmaier, MD
Novartis Pharmaceuticals Corporation