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Phase II Data on Lilly's Antibody Show It Affects Amyloid Beta, a Protein Believed To Be Associated with Alzheimer's Disease
Date:7/30/2008

blood. Amyloid plaques, the pathological hallmark of Alzheimer's disease, are composed largely of aggregated amyloid beta proteins. Amyloid plaques or other types of the amyloid beta protein are thought ultimately to disrupt normal nerve cell function in the brain, leading to the dementia that characterizes Alzheimer's disease.

"We are encouraged that in this study, we saw increased amyloid beta which is thought to be bound to LY2062430, in both the blood and cerebrospinal fluid. We hypothesize that this effect may lead to reduced formation of amyloid plaques in the brain after long-term treatment," said Eric Siemers, M.D., Medical Director, Alzheimer's disease research for Eli Lilly and Company. "Alzheimer's disease is complex, and there's a real need for new treatments that might be shown ultimately to slow disease progression. In addition to the biomarker results, we are particularly encouraged by the finding that patients who received the monoclonal antibody treatment over 12 weeks appeared to have no treatment-related side effects."

In this 12-week Phase II study, researchers gave 52 mild to moderate Alzheimer's disease patients infusions of placebo or LY2062430 in varying doses: 100mg or 400mg once a week, or 100mg or 400mg every four weeks. Alzheimer's disease symptom severity was also evaluated. In addition, 16 volunteers each received a single dose of 100mg of LY2062430 or placebo. For all study participants, safety assessments included magnetic resonance imaging (MRI) and cerebrospinal fluid examinations. A sub-study of 24 patients and 13 volunteers underwent single photon emission tomography (SPECT) scanning using an experimental tracer to assess levels of amyloid beta plaque in the brain.

The interim analysis showed that weekly infusions of LY2062430 up to 400mg per dose was well tolerated, with no side effects related to treatment. An evaluation of MRI brain imaging and an assessment of cerebrospinal fluid showed no evidence of brai
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SOURCE Eli Lilly and Company
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