Beta Amyloid in AD

A precise diagnostic tool is needed to reduce the time to accurate diagnosis

Diagnostic assessment of cognitive impairment during life is improved by detecting the presence or absence of β-amyloid neuritic plaques in the brain.

  • Structural imaging with MRI may not detect early disease or clearly distinguish the etiology of neuronal changes2

  • FDG-PET may not be able to detect cortical hypometabolism until several years after detectable β-amyloid pathology has occurred, and may not clarify the reason for the hypometabolism3, 4

  • Structural and metabolic changes remain surrogate rather than direct markers of dementia pathology4

  • Determining if cognitive decline is due to AD relies on detecting the presence of β-amyloid neuritic plaques

  • β-amyloid neuritic plaques accumulate early, before the onset of symptoms—but historically could only be visualized via post-mortem histopathology1

  • Symptoms alone make the diagnostic interpretation challenging; up to 39% of patients will not have a typical cognitive profile and disparities across cognitive domains occur even between "typical" patients5

Negative and positive scans with Neuraceq® help you clarify the clinical picture and plan the path ahead

Neuraceq® delivers valuable information for greater confidence in diagnosis and more personalized patient management.

VIEW A NEURACEQ SCAN 

  • Negative Neuraceq® PET scans allow you to consider alternative causes of cognitive impairment
  • A positive Neuraceq® PET 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 cognition1
  • Neuraceq® is an adjunct to other diagnostic evaluations and enables physicians and patients to plan accordingly
  • The safety and efficacy of Neuraceq® has not been fully established for the prediction of the development of dementia or other neurologic conditions
  • Symptoms alone make the diagnostic interpretation challenging: up to 39% of patients will not have a typical cognitive profile and disparities across cognitive domains occur even between "typical" patients3

FDG-PET, fludeoxyglucose positron emission tomography; MRI, magnetic resonance imaging.1Fodero-Tavoletti MT, Brockschnieder D, Villemagne VL, et al. In vitro characterization of [18F]-florbetaben, an AB imaging radiotracer. Nucl Med Biol. 2012;39(7):1042-1048. 2Bloudek LM, Spackman DE, Blankenburg M, Sullivan SD. Review and meta-analysis of biomarkers and diagnostic imaging in Alzheimer’s disease. J Alzheimers Dis. 2011;26(4):627-645 3Prestia A, Caroli A, van der Flier WM, et al. Prediction of dementia in MCI patients based on core diagnostic markers for Alzheimer’s disease. Neurology. 2013;80(11):1048-1056. 4Mosconi L, Berti V, Glodzik L, Pupi A, DeSanti S, de Leon MJ. Pre-clinical detection of Alzheimer’s disease using FDG-PET, with or without amyloid imaging. J Alzheimers Dis. 2010;20(3)843-854 5Snowden JS, Stopford CL, Julien CL, et al. Cognitive phenotypes in Alzheimer’s disease and genetic risk. Cortex. 2007;43(7):835-845. 6Grossberg GT, Christensen DD, Griffith PA, Kerwin DR, Hung G, Hall EJ. The art of sharing the diagnosis and management of Alzheimer’s disease with patients and caregivers: recommendations of an expert consensus panel. Prim Care Companion J Clin Psychiatry. 2010;12:PCC.09cs00833. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2882814, Accessed January 22, 2014. 7Neuraceq® (florbetaben F18 injection) prescribing information. Life Molecular Imaging; June 2025. Fareham, UK.

Neuraceq® - Product Indications And Use

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:

  • Risk for Image Misinterpretation and other Errors
    NEURACEQ Risk of Image Misinterpretation and Other Errors: Image interpretation errors have been observed. [see Section 5.1 of the full prescribing information]
  • 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 in the full prescribing information].

ADVERSE REACTIONS:

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

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 : Temporarily discontinue breastfeeding. A lactating woman should pump and discard breast milk for 24 hours after NEURACEQ administration.
  • Pediatric Use:  The safety and effectiveness of NEURACEQ have not been established in pediatric patients.
  • Geriatric Use: No overall differences in safety or effectiveness were observed between subjects 65 years of age and older and younger adult subjects.

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

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