Abstract Details

Title Efficacy, Safety and Tolerability of Rivastigmine Patch 13.3 mg/24h (15 cm2) Versus 4.6 mg/24h (5 cm2) in Patients with Severe Alzheimer's Disease: Results of the ACTivities of Daily Living and CognitION (ACTION) Study

Topic Clinical Neurophysiology

Presentation(s) P01 - (-)

Poster/Presentation
Number 039

Objective

Background Rivastigmine patch (4.6, 9.5 and 13.3 mg/24h) is approved for treatment of mild-to-moderate AD. Data suggest rivastigmine 13.3 mg/24h patch is efficacious at more advanced disease stages.

Design/Methods ACTION was a 24-week, prospective, randomized, double-blind, multicenter study in patients with severe AD. Patients aged ?50 years, with probable AD and Mini-Mental State Examination (MMSE) score of ?3-?12, were randomized (13.3 or 4.6 mg/24h patch). Co-primary outcomes were change from baseline at Week 24 on AD Cooperative Study-Activities of Daily Living scale-Severe Impairment Version (ADCS-ADL-SIV) and Severe Impairment Battery (SIB) in the Modified Full Analysis Set (MFAS), using a last observation carried forward (LOCF) approach. Sensitivity analysis included efficacy on co-primary outcomes using a pattern mixture model. ADCS-Clinical Global Impression of Change (ADCS-CGIC), 12-item Neuropsychiatric Inventory (NPI-12), safety and tolerability were secondary assessments.

Results Patients were randomized to 13.3 (n=356) or 4.6 mg/24h patch (n=360). Baseline characteristics and demographics were comparable. A similar proportion of both groups completed the study. Significantly less deterioration was observed on ADCS-ADL-SIV and SIB with 13.3 versus 4.6 mg/24h patch in the primary LOCF (p=0.0247 and p<0.0001, respectively) and sensitivity analyses (p=0.0161 and p<0.0001). Significant differences, in favor of high-dose patch, were observed on ADCS-CGIC (p=0.0023), but not NPI-12. The incidence of adverse events (AE) and serious AE (SAE) was comparable with 13.3 and 4.6 mg/24h patch (AE, 74.6% and 73.3%; SAE, 14.9% and 13.6%). Discontinuation due to AE and SAE was higher with 13.3 than 4.6 mg/24h patch (AE, 13.5% and 10.9%; SAE, 8.2% and 4.5%).

Conclusions 13.3 mg/24h rivastigmine patch showed benefit over 4.6 mg/24h on ADL and cognition in patients with severe AD. Preliminary safety review of 13.3 mg/24h patch appears consistent with previous studies.

Authors/Disclosures
Martin R. Farlow, MD, FAAN (Indiana University School of Medicine) PRESENTER	No disclosure on file
	No disclosure on file
Monique Somogyi, MD (Novartis Pharmaceuticals)	No disclosure on file
Martha Morrell, MD, FAAN (NeuroPace/Stanford University)	Dr. Morrell has received personal compensation for serving as an employee of NeuroPace. Dr. Morrell has stock in NeuroPace. The institution of Dr. Morrell has received research support from National Institutes of Health.

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