An international study of the first transdermal patch for patients with Alzheimer’s – a degenerative brain disease estimated to affect more than 15 million people worldwide – has shown that it may provide a promising new treatment approach1.
The six-month IDEAL trial of 1,195 patients with Alzheimer’s disease showed that the Exelon Patch provided benefits across a range of symptoms and the target dose was well tolerated. Results were presented today at the 10th International Conference on Alzheimer’s Disease and Related Disorders (ICAD), presented by the Alzheimer’s Association in Madrid, Spain.
Patients receiving Exelon Patch (rivastigmine transdermal patch) had significant improvements in memory and were better able to maintain everyday activities1 than those receiving placebo. They could also complete a concentration task up to 20 seconds faster compared to those taking placebo, and physicians considered Exelon Patch patients to have done better overall.
In addition, over 70% of caregivers in the IDEAL study preferred the patch to capsules as a method of drug delivery for reasons including helping them follow the treatment schedule, overall ease of use and less interference with daily life2, according to a questionnaire in the study.
“The patch represents an important new option for people with Alzheimer’s disease and their families,” said lead study investigator Professor Bengt Winblad of the Karolinska Institute in Stockholm, Sweden. “The target rivastigmine patch dose provided similar efficacy to that achieved at the highest doses of the capsule with three times fewer reports of nausea and vomiting. A transdermal patch may prove to be the best way to deliver rivastigmine to treat Alzheimer’s.”
Transdermal patches are designed to provide controlled, continuous delivery of drug through the skin. This maintains steady drug levels in the bloodstream, which may reduce side effects and consequently allow access to higher doses. In addition, patches may help caregivers to monitor treatment compliance because they provide visual reassurance that the medication has been taken.
“Although Alzheimer’s disease treatments have been available in oral forms for some time, we believe a patch may offer unique advantages for patients with this condition,” said James Shannon, MD, Global Head of Development at Novartis Pharma AG. “If approved, the Exelon Patch could potentially improve therapy compliance and help patients and their caregivers in reaching a better quality of life.”
Exelon is a cholinesterase inhibitor already approved in many countries for the treatment of mild to moderate Alzheimer’s disease and dementia associated with Parkinson’s disease. The IDEAL results will support the regulatory submission of the Exelon Patch to health authorities, planned by the end of 2006.
Source: Novartis AG