Alzheimer’s detection agent florbetaben in late phase studies

Florbetaben, a diagnostic agent to detect Alzheimer’s disease, is currently in last phase of clinical trials, the developer of the product Bayer announced.

Bayer began the enrolment of first patients in an international clinical phase-III trial to evaluate the efficacy and safety of florbetaben (BAY 94-9172) PET imaging in the detection of beta-Amyloid deposition in the brain.

The trial will include both subjects with and without manifest dementia (eg Alzheimer’s disease).

Florbetaben has successfully demonstrated its potential to detect beta-amyloid deposition in the brain in the previous phase-II trial. Beta-amyloid deposition is a pathological hallmark of disease in Alzheimer’s patients.

“This phase-III study could prove that florbetaben can be used as a new tool to detect beta-amyloid depositions in the brain in vivo,” stated Dr Thomas Balzer, head of Global Clinical Development Diagnostic Imaging at Bayer Schering Pharma.

The ability to image beta-amyloid depositions already during life, 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.”

The ability to image beta-amyloid depositions already during life, is expected to be beneficial for a better and earlier diagnosis of Alzheimer’s disease.

Currently, there is no diagnostic tool on the market to facilitate the in vivo diagnosis of the various dementia types including Alzheimer’s disease.

Florbetaben (BAY 94-9172) is an investigational positron emission tomography (PET) imaging tracer.

Florbetaben PET imaging scans may differentiate patients with probable Alzheimer’s disease from healthy volunteers, Bayer said presenting results from a global phase II study of florbetaben, its imaging agent in development for the detection of cerebral beta-amyloid plaques, at the 19th World Congress of Neurology (WCN).

Bayer’s Phase II study investigated the efficacy of florbetaben in differentiating between patients with a clinical diagnosis of probable Alzheimer’s disease and healthy volunteers (HVs).

Participants were evaluated using visual assessment of the uptake pattern of florbetaben in the brain and its ability to detect or exclude cerebral beta-amyloid plaques.

Current diagnosis of Alzheimer’s disease is based on cognitive tests that can only indicate a probability of having the disease.  A definitive clinical diagnosis of Alzheimer’s disease is only possible through a post-mortem autopsy or brain tissue biopsy.

Bayer’s global phase II, open-label, non-randomized, multi-center study, florbetaben was used to detect or exclude the presence of cerebral beta-amyloid plaques.

A total of 81 men and women with probable mild-to-moderate Alzheimer’s disease and 69 cognitively non-impaired healthy volunteers aged 55 and older were imaged with a single intravenous injection of florbetaben.

The florbetaben uptake pattern was visually assessed for all time points by three independent, nuclear medicine physicians blinded to the clinical diagnosis and all other clinical data.

PET images using florbetaben had a specificity of approximately 90 percent, results showed. This means that the florbetaben scan indicated the presence of cerebral beta-amyloid plaques in approximately 10 percent of the healthy volunteers.

Bayer’s florbetaben study results also showed a sensitivity of approximately 80 percent, meaning that about 80 percent of the subjects with probable Alzheimer’s disease had florbetaben scans indicating the presence of cerebral beta-amyloid plaques.

This is consistent with the results of studies where the clinical diagnosis of Alzheimer’s disease was compared with the definitive post-mortem histopathological diagnosis.  Additional data analysis is still ongoing in this study, Bayer said.

Florbetaben is an inlicensed 18F-labelled PET tracer that specifically binds to deposition of beta-Amyloid.