Bayer takes Alzheimer’s diagnostic into pivotal trials
pharmafile | December 2, 2009 | News story | Research and Development | Alz, Bayer, diagnostic
An imaging agent that can detect amyloid plaques in the brains of Alzheimer’s patients and so may provide an accurate diagnosis of the disease has been advanced into phase III testing by its developer, German drugmaker Bayer Schering Pharma.
At present, a definitive diagnosis of Alzheimer’s is only possible when the patient’s brain is examined for the presence of amyloid plaques post mortem.
When patients first present with symptoms, clinicians must rely on a mix of cognitive testing and magnetic resonance imaging (MRI) and computed tomography (CT) scans to exclude other forms of dementia. These measures are around 70-80% reliable.
Florbetaben is an injectable, radiolabelled tracer that can be measured using PET (positron emission tomography), an imaging technique that produces a three-dimensional image of functional processes in the body. It has been designed to bind to the beta-amyloid in plaques and so allow them to be detected while the patient is still alive.
If the latest trials bear out florbetaben’s early promise, the agent “is expected to be beneficial for a better and earlier diagnosis of this devastating disease and to eventually enable also an earlier and more specific treatment”, according to Dr Thomas Balzer, head of global clinical development diagnostic imaging at Bayer Schering Pharma.
The phase III trial will enrol 400 patients, some without any evidence of dementia, and others with Alzheimer’s-type dementia that has been diagnosed using current criteria. The correlation between the clinician’s diagnosis and the tracer images will be compared, with initial results due in 2011.
The study is not expected to be fully completed until 2014, however, when histopathology samples from the patients become available.
A study of florbetaben alongside a vaccine designed to break down amyloid plaques, developed by Swiss company AC Immune, got underway a few weeks ago. In this study florbetabin will be used to gauge the effectiveness of the vaccine in dissolving plaques, as well as helping to guide dose selection.
It may also provide an opportunity to test whether amyloid plaques are responsible for the degeneration of nerves in Alzheimer’s or merely a manifestation of some other disease process.
In September, a study of a compound called dimebolin undermined the amyloid hypothesis by showing a beneficial effect on cognitive symptoms despite increasing levels of amyloid in the brain.
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