Bayer (BAYGn.DE) has started enrolling participants for the last stage of testing of its Alzheimer’s marker florbetaben, which could offer a way to diagnose early onset of the disease, the drugmaker said on Monday.
About 400 individuals will be enrolled for the third phase of testing usually required for regulatory approval, to assess its potential to detect the debilitating disease.
In a Phase II study, florbetaben was shown to help diagnose the illness in eight out of 10 cases, it had said in June.
Injection of florbetaben highlights beta-amyloid plaques, which are associated with Alzheimer’s, in patients’ brains under a positron emission tomography (PET) scan.
Currently, the illness can only be reliably diagnosed when symptoms such as memory loss, language breakdown and impaired movement are advanced and only a post-mortem brain tissue examination can bring absolute certainty.
The company does not provide an annual peak sales estimate for the product.