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Joel S. Ross, MD |
MD FACP AGSF CMD CPI |
President and Founder |
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« Why Alzheimer’s Disease, should be renamed Reagan’s Disease. | Home | Iberica USA opens its new State of Art Phase I/IIA Facility »
New Approaches to Alzheimer’s Disease Treatments
By Joel Ross | January 17, 2008
Want to know the newest ways to treat AD?
Elan progresses two of its Alzheimer’s compounds with partners
Elan and Transition Therapeutics have started a Phase II trial of the potential Alzheimer’s disease compound they are jointly developing, ELND005 (formerly AZD-103).
ELND005 is an orally administered product that was shown in animal models to act by preventing and reversing the formation of beta-amyloid fibrils, thus reducing the accumulation of amyloid plaques in the brain.
The randomised, double-blind, placebo-controlled, dose-ranging study will enrol around 340 patients with mild-to-moderate Alzheimer’s disease over approximately 18 months to assess both cognitive and functional endpoints. In Phase I trials in 110 healthy volunteers, it was found to be safe and well tolerated at all doses and regimens and no severe or serious adverse events were seen.
Wyeth compound
Elan, along with its co-development partner Wyeth, has also announced the advancement of another of Alzheimer’s programme, bapineuzumab (AAB-001), a humanised monoclonal antibody that binds to and clears beta-amyloid peptide without the patient needing to mount an immune response. A Phase III programme is under way in North America and will shortly involve equal participation from the rest of the world. The trial is expected to last 18 months.
The companies say that AAB-001 represents the first known late-stage investigational antibody for Alzheimer’s disease. This condition is the most common form of dementia and is estimated to affect more than five million Americans and more than 24 million people worldwide. Currently, the main approved treatments are acetylcholinesterase inhibitors, with Eisai/Pfizer’s Aricept (donepezil) being the most well known, but these only treat the symptoms of Alzheimer’s. Merz’s NMDA antagonist memantine is also approved for the disorder.
The Phase III programme will include four randomised, double-blind, placebo-controlled studies in around 4,000 patients with mild-to-moderate Alzheimer’s disease. The co-primary efficacy endpoints will include one cognitive and one functional endpoint and patients will be evaluated using several methods, including neuropsychiatric scales and imaging and biomarker analysis.
Elan has a third Alzheimer’s programme, also in collaboration with Wyeth: ACC-001, an active A-beta immunotherapeutic conjugate, which is in Phase I trials. The conjugate is intended to induce a highly specific antibody response to beta-amyloid.
Topics: Alzheimer’s Disease, Clinical Research Study, Clinical Trials | No Comments »