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NEUROLOGY 2007;69:S14-S22
© 2007 American Academy of Neurology

IDEAL

A 6-month, double-blind, placebo-controlled study of the first skin patch for Alzheimer disease

B. Winblad, MD, G. Grossberg, MD, L. Frölich, MD, M. Farlow, MD, S. Zechner, PhD, J. Nagel, PhD and R. Lane, MD

From the Karolinska Institutet Alzheimer Research Center, Stockholm, Sweden (Prof. Winblad), St. Louis University School of Medicine, St Louis, Missouri (Prof. Grossberg), Ruprecht-Karls-Universität Central Institute for Mental Health, Heidelberg, Mannheim, Germany (Prof. Frölich), Indiana University School of Medicine, Indianapolis, Indiana (Prof. Farlow), Novartis Pharma AG, Basel, Switzerland (Drs. Zechner and Nagel), and Novartis Pharmaceuticals Corporation, East Hanover, New Jersey (Dr. Lane).

Address correspondence and reprint requests to Prof. Bengt Winblad, Karolinska Institutet Alzheimer Research Center, NOVUM, Floor 5, S-14157 Huddinge, Sweden Bengt.Winblad{at}ki.se

The rivastigmine patch is the first transdermal treatment for Alzheimer disease (AD). By providing continuous delivery of drug into the bloodstream over 24 hours, transdermal delivery may offer benefits superior to those of oral administration. This study compared the efficacy, safety and tolerability of rivastigmine patches with capsules and placebo. IDEAL (Investigation of transDermal Exelon in ALzheimer’s disease) was a 24-week, double-blind, double-dummy, placebo- and active-controlled study. Patients with AD were randomized to placebo or one of three active treatment target dose groups: 10-cm2 rivastigmine patch (delivering 9.5 mg/24 hours); 20-cm2 rivastigmine patch (17.4 mg/24 hours); or 6-mg BID rivastigmine capsules. Primary efficacy measures were the Alzheimer’s Disease Assessment Scale–Cognitive subscale and Alzheimer’s Disease Cooperative Study–Clinical Global Impression of Change. Secondary outcome measures assessed a range of domains, including behavior, cognitive performance, attention, executive functions, and activities of daily living. A total of 1,195 AD patients participated. All rivastigmine treatment groups showed significant improvement relative to placebo. The 10-cm2 patch showed similar efficacy to capsules, with approximately two-thirds fewer reports of nausea (7.2% vs 23.1%) and vomiting (6.2% vs 17.0%), incidences statistically not significantly different from placebo (5.0% and 3.3% for nausea and vomiting, respectively). The 20-cm2 patch showed earlier improvement and numerically superior cognitive scores vs the 10-cm2 patch with similar tolerability to capsules. Local skin tolerability was good. The transdermal patch with rivastigmine may offer additional therapeutic benefits and may prove to be the best delivery system for this drug to treat AD.

Disclosure: Prof. Winblad, Prof. Grossberg, and Prof. Frölich have received personal honoraria and grant support from the sponsor during their careers. Prof. Farlow has received personal honoraria (in excess of $10,000) and grant support from the sponsor during his career. Dr. Nagel, Dr. Zechner, and Dr. Lane are employees of the sponsor and have equity or ownership interest. This supplement has been made possible by an educational grant by Novartis Pharma AG, Basel, Switzerland.




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