FDA approves biomarker for Alzheimer's disease

The Food and Drug Administration recently approved a biomarker used for the early diagnosis of Alzheimer’s disease.

Piramal Imaging developed the biomarker, called Neuraceq, an agent used in Positron Emission Tomography imaging of the brain. The biomarker allows researchers to image a type of plaque associated with Alzheimer’s, said Emily Fisher, public relations for Piramal Imaging.

“Beta-amyloid plaques are microscopic clumps of protein that build up in the brain,” Fisher said. “Researchers believe the plaque damages brain cells, which can disrupt cell-to-cell communication [and] activate immune cells that devour and ultimately kill disabled cells.”

Neuraceq has two applications: one as an aid in diagnosing patients with Alzheimer’s disease symptoms, the other as a test for asymptomatic patients to determine whether or not they will develop the disease.

“Neuraceq is not a stand-alone diagnostic tool,” said Fisher. “It is used in conjunction with other clinical evaluations, including medical history, mental status testing and a physical and neurological exam.”

When using Neuraceq, if the scan is positive, chances are that it’s Alzheimer’s disease, said Dr. Geoff Ahern, the medical director of Behavioral Neuroscience and Alzheimer’s Clinic and professor of neurology, psychology and psychiatry at the UA. If it’s negative, then a different form of dementia may be present.

The biomarker can also be used in patients who do not display symptoms of Alzheimer’s disease, but are at risk because of family history, for example.

Research is still being done on this application, but the outlook appears favorable.
“There is good evidence that amyloid scans will be positive prior to the development of overt symptoms,” said Dr. Phillip Kuo, Chief of Nuclear Medicine and Director of PET/CT at the UA. “[The application] may be advantageous for early detection.”

Neuraceq may be the newest development in Alzheimer’s diagnosis, but it is not the only imaging agent around. Another biomarker, Amyvid, developed by Eli Lilly, became the first beta-amyloid marker to be approved by the FDA in 2012.

“Amyvid and Neuraceq are similar,” said Kuo. “Basically, the imaging agents allow one to visualize amyloid in the brain without the need for a biopsy.”

Along with genetic testing, amyloid imaging technologies are paving the way for doctors looking to accurately predict Alzheimer’s disease, which, according to the Alzheimer’s Association, accounts for 60 to 80 percent of dementia cases.

—Follow Dara Farhadi @Dara_Farhadi


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