About Neuraceq®

about-neuraceq

High quality scans lead to better patient management decisions

Neuraceq® assists in the diagnostic assessment of cognitive impairment – helping you plan the clinical path ahead

  • Scientifically proven ability to detect the presence or absence of β-amyloid neuritic plaques, as demonstrated in a robust clinical trial program
  • FDA approved for amyloid plaque quantification and patient selection for amyloid-targeting therapies
  • High sensitivity and specificity
  • Reproducibility and reliability of visual assessment
  • A demonstrated safety profile with a low radiation dose
  • A wide, stable, and flexible scanning window

Diagnostic performance of Neuraceq® PET was thoroughly validated in a histopathology study, used in the real-world IDEAS study and in AD drug development studies

  • High sensitivity and specificity1
  • Approximately 30% of scans in IDEAS were performed with Neuraceq®2
  • Neuraceq®was involved in major AD drug development studies and used for confirming eligibility criteria3

Reliability and reproducibility of the clinically applicable image interpretation methodology was confirmed1

This was validated in a study with 5 newly trained readers by way of electronic media training; 454 images from previous clinical studies were included from subjects with a range of diagnoses.

Inter-reader agreement across all 5 readers had a kappa coefficient of 0.79 (95% CI 0.77, 0.83

Inter-reader reproducibility assessed from 46 images (10% of overall sample) ranged from 91% to 98%

PET reading results from IDEAS investigators confirmed by expert readers

Average interrater agreement between individual experts and local readers was highest for Neuraceq® among all three amyloid PET tracers used in IDEAS study4

1. Neuraceq® (florbetaben F18 injection) prescribing information. Life Molecular Imaging; June 2025. Fareham, UK.

2. La Joie et al. AAIC 2023

3. van Dyck et al. 2022, Sims et al. 2023, Bateman et al. 2023

4. Windon C. et al. HAI 2024

Neuraceq® has an established safety profile and a low radiation dose

The safety of Neuraceq® was evaluated in 872 subjects from 9 clinical trials

There were no reported serious adverse reactions (ARs) in these trials

All reported ARs were mild to moderate and of short duration

The most common ARs were erythema (1.7%), irritation (1.1%), and pain (3.4%) at the injection site

Neuraceq® delivers a lower radiation dose than a typical chest CT scan.

 
 
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LEARN MORE ABOUT BETA AMYLOID IN AD

Neuraceq® - Indications, Use and Important Safety Information

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

X
INDICATION

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
  • Selection of patients who are indicated for amyloid beta-directed therapy as described in the prescribing information of the therapeutic products

Please see full Prescribing Information for NEURACEQ®

IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Risk of Image Misinterpretation and Other Errors

Image interpretation errors have been observed. Errors may occur in the estimation of brain amyloid beta neuritic plaque density during NEURACEQ® image interpretation. The use of clinical information in the interpretation of NEURACEQ® images has not been evaluated and may lead to an inaccurate assessment. Severe brain atrophy as well as motion artifacts that result in image distortion may limit the ability to distinguish gray and white matter on a NEURACEQ® scan. Perform image interpretation independently of the patient’s clinical information. For cases where there is uncertainty as to the location of cortical signal, use co-registered anatomical imaging to improve localization of signal.

Radiation Risk

NEURACEQ® 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 drug handling to protect patients and health care providers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration.

ADVERSE REACTIONS

Most common adverse reactions (incidence ≥1%) were injection site pain, injection site erythema, and injection site irritation.

USE IN SPECIFIC POPULATIONS

Lactation: Temporarily discontinue breastfeeding. A lactating woman should pump and discard breast milk for 24 hours after NEURACEQ® administration.

To report suspected adverse reactions of NEURACEQ®, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. or Lantheus Biosciences Ltd. at 1-833-491-2524 or phv@lantheus.com.

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