HOFFMAN ESTATES, Ill. and LOS ANGELES, Dec. 20, 2006 – Siemens Medical Solutions will begin clinical trials under an investigational new drug (IND) application submitted to the Food and Drug Administration (FDA) for a breakthrough imaging biomarker that could potentially identify Alzheimer’s disease prior to the onset of noticeable symptoms.

Siemens will collaborate with leading Alzheimer’s researchers at the University of California, Los Angeles (UCLA) to launch a Phase I, Open Label, Single Center Safety Study of one of the first imaging biomarkers designed to identify Alzheimer’s disease pathology specifically. The study will employ a new diagnostic technique developed by UCLA researchers that combines the new imaging biomarker and positron emission tomography (PET). The technique was first reported in the January 2002 issue of the American Journal of Geriatric Psychiatry.

“The clinical diagnosis of Alzheimer’s disease is not definitive, but when it occurs, it is frequently late in the disease progression,” said Dr. Jorge R. Barrio, professor of medical and molecular pharmacology, UCLA, and co-inventor of the imaging biomarker. “This means that physicians would treat the disease only after it had already caused brain damage and impaired the patient’s memory and daily functioning. Use of this biomarker technology may provide physicians with an early diagnostic tool and information in order to help identify susceptible individuals and allow for the early start of a treatment plan before

symptoms appear.”

Traditionally, PET, using the currently approved imaging agent 18F-fluorodeoxyglucose (FDG), measures metabolic function in cells. FDG-PET has been used for years in aiding diagnosis of various neurological conditions including Alzheimer’s and Parkinson’s disease. However, FDG cannot identify the abnormal brain protein deposits – amyloid plaques and tangles – that may cause Alzheimer’s. Current anti-dementia drug development is focusing on treating and preventing the accumulation of these deposits.

After Phase 1, the study protocol will focus on the use of the biomarker in patient populations and its potential to seek out tangles and plaques in the living brain of Alzheimer’s disease patients. Using PET imaging, biomarker molecules are considered to have the potential to “light up” the parts of the brain with high concentrations of the imaging biomarker; through analysis of the PET data, researchers can thus identify the disease specifically, and do so in advance of the onset of symptoms.

More Industry Headlines