What is Neuraceq®
Neuraceq® has been well-studied
Neuraceq® was studied in a large clinical trial program for this type of agent. This program was approved by the Food and Drug Administration (FDA) and European Medicines Agency (EMA).
A memory or thinking test can tell a doctor if you have cognitive impairment. However, it cannot tell your doctor the cause of the problem.
An image of the brain, or a “scan,” gives your doctor a minimally invasive way to look inside the brain to see what might be causing memory and thinking problems.
The most common cause of cognitive impairment due to a neurodegenerative disease is Alzheimer’s disease (AD). In AD, sticky clumps of protein called beta(β)‐amyloid plaques build up in the brain, affecting the way the brain works.
Neuraceq® is a radioactive tracer designed to stick to β-amyloid neuritic plaques in the brain for a short time. When used with PET scanning to create an image of your brain, Neuraceq® can reveal the presence or absence of β-amyloid plaque.
Neuraceq® has been well-studied
Neuraceq® was studied in a large clinical trial program for this type of agent. This program was approved by the Food and Drug Administration (FDA) and European Medicines Agency (EMA).
It was demostrated that Neuraceq® is an accurate diagnostic tool for the estimation of β-amyloid neuritic plaque in the living brain.
Neuraceq® is radioactive but only stays active in the brain for a short time. More than half of it disappear within 2 hours of being injected.
No serious side effects related to Neuraceq® have been reported. All side effects were mild to moderate and of short duration.
PRODUCT INDICATIONS AND USE: NEURACEQ is a radioactive diagnostic drug indicated for positron emission tomography (PET) of the brain to estimate amyloid beta neuritic plaque density in adults with cognitive impairment for: Evaluation of Alzheimer’s disease (AD) and other causes of cognitive decline, and selection of patients who are indicated for amyloid beta-directed therapy as described in the prescribing information of the therapeutic products.
NEURACEQ IMPORTANT SAFETY INFORMATION:
CONTRAINDICATIONS: None
WARNINGS AND PRECAUTIONS:
ADVERSE REACTIONS:
USE IN SPECIFIC POPULATIONS:
OVERDOSAGE:
In the event of administration of a radiation overdose with NEURACEQ, the absorbed organ dose to the patient should be reduced by increasing elimination of the radionuclide from the body by inducing frequent micturition. Prior to NEURACEQ administration, please read the full Prescribing Information for additional Important Safety Information.
SUSPECTED ADVERSE REACTIONS: please report to: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program