Florbetaben scan detects beta-amyloid plaques in Alzheimer’s patients: Bayer

Florbetaben imaging may differentiate patients with probable Alzheimer’s disease from healthy

Bayer HealthCare has developed florbetaben an imaging agent to help detection of beta-amyloid plaques in Alzheimer’s disease patients.

Cerebral beta-amyloid plaques are one of the pathological hallmarks of 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 in-licensed 18F-labeled PET tracer currently being investigated for imaging of cerebral beta-amyloid plaques, which are one of the pathological hallmarks of Alzheimer’s disease.

Florbetaben is a leading candidate in Bayer’s efforts to build a strong pipeline of PET tracers in neuroimaging,oncology, and cardiovascular disease.  Additional phase II and pivotal phase III global studies are under preparation to validate the potential shown by
florbetaben in this phase II setting. Start of the phase III program is planned for end of 2009.

Amyloidosis is a disease caused by the build-up of abnormal proteins (amyloids) in body tissues, which leads to organ failure. The heart, kidneys, liver, and almost any other organ can be affected. Around 500 new cases are diagnosed each year in the UK, and – despite the fact that patients receive the best available therapy – the prognosis for patients is poor and new treatments are urgently needed.

Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG.

Bayer HealthCare is one of the world’s leading companies that combines the activities of the Animal Health,Consumer Care, Diabetes Care, and Pharmaceuticals divisions.

Bayer HealthCare Pharmaceuticals comprises: Women’s Healthcare, Diagnostic Imaging, General Medicine, which includes Cardiology and Primary Care and Specialty Medicine, which includes Hematology, Oncology and Multiple Sclerosis.