Cognitive impairment could be due to Alzheimer's disease, or not.

Knowing can help you plan the path ahead

When memory loss begins to affect daily life, knowing the cause is critical. A brain scan with Neuraceq® gives your doctor information that can help assess your condition.

Neuraceq® gives physicians a “window into the brain”

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 non-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. It is 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® gives physicians a “window into the brain”

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 non-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. It is 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.

Accurate diagnostic tool

It was demostrated that Neuraceq® is an accurate diagnostic tool for the estimation of β-amyloid neuritic plaque in the living brain

Only Active for a Short time

Neuraceq® is radioactive but only stays active in the brain for a short time. More than half of it will be eliminated from the body within 2 hours of being injected

No serious side effects

No serious side effects related to Neuraceq® use have been reported. All side effects were mild to moderate and of short duration

Neuraceq® has been
well-studied

Neuraceq® was studied in the largest clinical trial program for this type of agent. This program was reviewed by the Food and Drug Administration (FDA) and European Medicines Agency (EMA).
PET SCAN

Preparing for your Neuraceq® PET scan

PET SCAN

Checklist

  • Wear comfortable clothing with no metal parts. You should not wear jewelry. You may be asked to remove items containing metal, such as eyeglasses
  • Be sure to bring a list of all the medications you are currently taking, and be ready to share your medical history
PET SCAN

What to expect

A Neuraceq® PET scan involves an injection into a vein in your arm and a short scan. After the injection, some saline solution (salt water) may be injected to help the Neuraceq® move more quickly through the bloodstream.

Injection
Injection

The Neuraceq® injection is given through an IV (intravenous) tube

45+ Minutes
45+ Minutes

The Neuraceq® PET scan can be done 45 to 130 minutes after injection and usually lasts 15 to 20 minutes

During the scan
During the scan

During the scan, you will lie down on a table while the PET-scanner camera passes overhead

After the scan
After the scan

After the scan, an imaging specialist will view the results, write a report, and send it to your doctor

PET SCAN

What to expect

A Neuraceq® PET scan involves an injection into a vein in your arm and a short scan. After the injection, some saline solution (salt water) may be injected to help the Neuraceq® move more quickly through the bloodstream.

Injection
Injection

The Neuraceq® injection is given through an IV (intravenous) tube

45+ Minutes
45+ Minutes

The Neuraceq® PET scan can be done 45 to 130 minutes after injection and usually lasts 15 to 20 minutes

During the scan
During the scan

During the scan, you will lie down on a table while the PET-scanner camera passes overhead

After the scan
After the scan

After the scan, an imaging specialist will view the results, write a report, and send it to your doctor

A negative or positive scan can help give you and your doctor clarity to move forward

During your follow-up appointment, your doctor will review your Neuraceq® PET scan along with results from other tests to figure out whether your cognitive impairment may be due to AD or something else.

Emilia Clarke
A Positive scan
If the Neuraceq® PET scan is positive, it can help your doctor figure out if you have AD. β-amyloid neuritic plaques are sticky clumps of protein that form in the brains of people who have AD. However, β-amyloid plaques may also be present in other diseases and in people without cognitive symptoms. These plaques affect the way the brain works. The presence of β‐amyloid plaques is a key component for the confirmation of AD.
Emilia Clarke
A Negative scan
If the Neuraceq® PET scan is negative, your doctor may consider different causes of cognitive impairment that are not due to AD.





Get the most out of your discussion

Here are some things to help to prepare for your appointment and questions to ask in order to understand the results of your scan. You may want to consider asking a friend or family member to support you.

  • Write down a list of all medications you are taking
  • Write down important information about your medical history
  • Come up with a list of questions you may have for the doctor
  • Take notes during the appointment
  • What did my Neuraceq® PET scan show?
  • What do my results mean?
  • What steps do I need to take?
  • What else do you recommend?
FAQ

Frequently Asked Questions about Neuraceq®

Who is Neuraceq® for?
Neuraceq® is for adults who are experiencing unexplained memory loss or problems with thinking. A Neuraceq® PET scan can give your phyician important information about what could be causing your memory or thinking problems.
Where can I get additional information about Neuraceq® ?

If you have not found the information you need on this website, or want more information about Neuraceq®, please speak with your doctor and refer to the Full Prescribing Information.

You can also contact us at:

Life Molecular Imaging
75 State Street, Floor 1
Boston, MA 02109
Phone: 617-725-0070

General Information: info@life-mi.com

Adverse Event Reporting: You are encouraged to report side effects of Neuraceq® by calling 1-855-545-5245. Suspected adverse reactions can also be reported directly to the FDA by visiting MedWatch or calling 1-800-FDA-1088.

Does Neuraceq® diagnose Alzheimer's disease?

Your doctor will use your Neuraceq® PET scan results, along with other tests and observations, to help make a diagnosis. A negative scan is not consistent with a diagnosis of AD and allows your doctor to explore other possible causes of your memory or thinking problems. A positive Neuraceq® PET scan reveals the presence of β-amyloid plaques in the brain. β-amyloid plaques are sticky clumps of protein that are a key indicator of AD, but are also sometimes seen in other diseases and in healthy people without memory problems.

 

What are some of the benefits of getting a Neuraceq® PET scan?

Neuraceq® alone does not diagnose AD, it should be used in conjunction with other tests done by your doctor to make a diagnosis. Having a diagnosis allows you (and/or your loved one) to be involved in planning the path forward. Being able to participate early in the planning of care and other important decisions, such as finances, allows you to have more control in making the decisions that are right for you.

How can I get a Neuraceq® PET scan?

Only your doctor can determine if a Neuraceq® PET scan is appropriate for you.

 

Important Safety Information

Risk for Image Misinterpretation and Other Errors
Neuraceq® can be used to estimate the density of β-amyloid neuritic plaque deposition in the brain. Neuraceq® is an adjunct to other diagnostic evaluations. Neuraceq® images should be interpreted independent of a patient’s clinical information. Physicians should receive training prior to interpretation of Neuraceq® images. Following training, image reading errors (especially false positive) may still occur. Additional interpretation errors may occur due to, but not limited to, motion artifacts or extensive brain atrophy.

Radiation Risk
Administration of Neuraceq®, similar to other radiopharmaceuticals, contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. It is important to ensure safe handling to protect patients and health care workers from unintentional radiation exposure.

Most Common Adverse Reactions
In clinical trials, the most frequently observed adverse drug reactions in 872 subjects with 1090 Neuraceq® administrations were injection/application site erythema (1.7%), injection site irritation (1.1%), and injection site pain (3.4%).

Medwatch link (for adverse event reporting)

Neuraceq® - Product Indications And Use

PRODUCT INDICATIONS AND USE: Neuraceq is indicated for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s Disease (AD) and other causes of cognitive decline. A negative Neuraceq scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient’s cognitive impairment is due to AD. A positive Neuraceq scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Neuraceq is an adjunct to other diagnostic evaluations.

Limitations: Limitations of Use
A positive Neuraceq scan does not establish the diagnosis of AD or any other cognitive disorder. The safety and effectiveness of Neuraceq have not been established for Predicting the development of dementia or other neurologic conditions or monitoring responses to therapies.

IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS: None

WARNINGS AND PRECAUTIONS

  • Risk for Image Misinterpretation and other Errors
    Errors may occur in the Neuraceq estimation of brain neuritic β-amyloid plaque density during image interpretation [see Clinical Studies (14)]. Image interpretation should be performed independently of the patient’s clinical information. The use of clinical information in the interpretation of Neuraceq images has not been evaluated and may lead to errors. Errors may also occur in cases with severe brain atrophy that limits the ability to distinguish gray and white matter on the Neuraceq scan. Errors may also occur due to motion artifacts that result in image distortion. Neuraceq scan results are indicative of the presence of brain neuritic β-amyloid plaques only at the time of image acquisition and a negative scan result does not preclude the development of brain neuritic β-amyloid plaques in the future.
  • Radiation Risk
    Neuraceq, similar to other radiopharmaceuticals, contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure [see Dosage and Administration.

ADVERSE REACTIONS:

  • The most commonly reported adverse reactions in clinical trials were injection site pain (3.4%), injection/appliucation site erythema (1.7%), injection site irritation (1.1%).

DRUG INTERACTIONS

  • Drug-drug interaction studies have not been performed in patients to establish the extent, if any, to which concomitant medications may alter Neuraceq image results.

USE IN SPECIFIC POPULATIONS

  • Pregnancy: All radiopharmaceuticals, including Neuraceq, have a potential to cause fetal harm depending on the stage of fetal development and the magnitude of the radiopharmaceutical dose. If considering Neuraceq administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from the drug and the gestational timing of exposure.
  • Lactation: There are no data on the presence of florbetaben F 18 injection in human milk, the effects on the breastfed infant, or the effects of florbetaben F 18 injection on milk production. Exposure of Neuraceq to a breastfed infant can be minimized by temporary discontinuation of breastfeeding. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Neuraceq and any potential adverse effects on the breastfed child from Neuraceq or from the underlying maternal condition.
  • Pediatric Use: Neuraceq is not indicated for use in pediatric patients.
  • Geriatric Use: No overall differences in safety were observed between older and younger subjects

OVERDOSAGE
A pharmacological overdose of Neuraceq is unlikely given the relatively low doses used for diagnostic purposes. 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

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