December 22, 2006
Siemens Medical Solutions will partner with leading Alzheimer’s researchers at the University of California, Los Angeles (UCLA) to test a new biomarker that could potentially identify the disease before the onset of noticeable symptoms.
Clinical trials under an investigational new drug application submitted to the Food and Drug Administration (FDA) will launch a Phase 1, 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 diagnostic technique developed by UCLA researchers that combines the biomarker and position emission tomography (PET).
After Phase 1, the study protocol will focus on the use of the biomarker in patient populations and its potential to seek out abnormal brain protein deposits –amyloid plaques and tangles – that may cause Alzheimer’s. 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 identify the disease specifically in advance of the onset of symptoms.
After the Phase I study, depending on its outcome, the company will initiate a larger multi-center clinical trial.
