Risk for Image Interpretation 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)
http://www.fda.gov/Safety/MedWatch/default.htm


Neuraceq™ assists in the diagnostic assessment of cognitive impairment, helping you plan the clinical path

Neuraceq accurately visualizes β-amyloid neuritic plaques for more personalized patient management.

Scientifically proven ability to detect the presence or absence of β-amyloid neuritic plaques, as demonstrated in a robust clinical trial program

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

Neuraceq was evaluated in a
robust clinical trial program

The efficacy and safety of Neuraceq have been demonstrated through the largest
clinical trial program of an F18 β-amyloid neuritic plaques positron emission tomography (PET) tracer1

The safety of Neuraceq was evaluated in 872 subjects

1Neuraceq [prescribing information]. Life Molecular Imaging; 2016

Highly sensitive β-amyloid detection with both reader
training methods (n=82)1

High sensitivity to detect β-amyloid was achieved with both in-person and electronic media training1

  • Images were taken from 205 end-of-life subjects enrolled and compared with postmortem histopathology as the Standard of Truth (SoT) in 82 subjects
    • The histopathologic examination used Bielschowsky silver staining (BSS) of 6 brain regions assessed by a Pathology Consensus Panel masked to all clinical information
  • Study A evaluated Neuraceq PET images with 3 readers who received in-person training
  • Study B used 5 readers who underwent training with electronic media

1Neuraceq [prescribing information]. Life Molecular Imaging; 2016

Training for Neuraceq is provided to ensure proper
interpretation of scan images

a median: 98%; range: 96%-98%. b median: 80%; range: 77%-83%. c median: 96%; range: 90%-100%. d median: 77%; range: 47%-80%.

Study C evaluated the reliability and reproducibility of the clinically applicable image interpretation
methodology using the electronic media training; 461 images from previous clinical studies were included
from subjects with a range of diagnoses.

Five new readers underwent training with electronic media

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

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

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.

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

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

Assessment of cognitive decline due to AD depends on detecting the presence or absence of β-amyloid neuritic plaques

β-amyloid neuritic plauqes accumulate early, before the onset of symptoms—but until recently could only be visualized via postmortem 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

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 Psyciatry. 2010;12:PCC.09cs00833. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2882814, Accessed January 22, 2014.

A typical patient experiences symptoms for >2 years and visits an average of 2.3 doctors before receiving a diagnosis6

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.

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 cognition.3

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.

A positive scan alone does not establish the diagnosis of AD or any other
cognitive disorder, particularly in the absence of cognitive impairment.

3Neuraceq [prescribing information]. Life Molecular Imaging; 20163Prestia 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.

Neuraceq™ delivers sensitive and reliable
detection of β-amyloid neuritic plauqes

Neuraceq is an accurate diagnostic tool to aid in the evaluation of cognitive decline1

  • Neuraceq reveals β-amyloid neuritic plaques by uptake in different brain regions, thereby allowing an estimate of plaque density by degree of uptake1

Visual assessment is based on the systematic comparison of tracer uptake in gray and white matter,
focusing on specific cortical regions, as seen in black and white scan images

Top row images are negative scans, corresponding to lower tracer uptake in gray matter than white matter, and reduced likelihood that cognitive decline is a result of AD

Bottom row images show positive scans with equal or higher tracer uptake in gray matter than white matter and moderate to frequent β-amyloid neuritic plaques

1Neuraceq [prescribing information]. Life Molecular Imaging; 2016.

Neuraceq scan reports can help facilitate dialogue
between physicians, patients, and caregivers

While the actual diagnosis is made by reading the black and white scans, useful reports provided to you
by your patient's imaging specialist include an accompanying written assessment.

NeuraLinQ connects you to your patient's imaging specialist

To facilitate communication with your patient's imaging specialist, access is also provided to NeuraLinQ.

NeuraLinQ offers:

  • A digital online community
  • A platform for information exchange regarding patients' Neuraceq scans and diagnostic reports
  • A secure, compliant portal for exchanging medical information

The Neuraceq scan is convenient for patients

Neuraceq provides a wide, stable scan window and a short scan time, making the process quick
and convenient for your patients. A Neuraceq PET scan involves an injection
into a vein in the arm and a short scan.

Neuraceq™ Injection

Wait at least 45 minutes before PET scan can begin

The PET scan lasts 15 to 20 minutes

The PET scan should be completed within about 2 and a half hours after injection

Frequently Asked Questions
about Neuraceq™

Is Neuraceq currently available?

Neuraceq was FDA approved in March 2014 and is available in many imaging centers across the US.

Contact Us for specific details on Neuraceq availability in your area or send an email to sales@life-mi.com.

What role can this test play in the diagnostic process?

Neuraceq can give you important information in cases where Alzheimer's disease is suspected. If the scan is positive, it means that beta amyloid plaques are present in the brain. If the scan is negative, it means that beta amyloid plaques are not present, and another diagnosis can be considered.

How does a positive or negative scan assist in my ability to assess patients?

Early detection and intervention can benefit patients. Neuraceq alone does not diagnose AD, it should be used in conjunction with other tests. Having a diagnosis gives patients the opportunity to plan ahead. Pharmacological and non-pharmacological interventions can begin sooner. Knowing a diagnosis gives patients the opportunity to take part in clinical trials.

Do you have any materials I can provide to my patient to help explain the Neuraceq scan?

Our patient and Caregiver information can be viewed on our patient and caregiver page. If you would like a printed copy of the brochure please contact 617-725-0070 or send an email to sales@life-mi.com.

Who can I contact for more information?

Contact Us for more information.

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Resources & Support

 

Case Study 1

72-year-old man, with cognitive and behavioural disturbances for 1.5 years

Disclaimer

  • The following case examples assume that interpretation of the beta-amyloid imaging PET data has been completed independently of the patient’s clinical evaluation. The use of clinical information in the interpretation of Neuraceq images has not been evaluated and may lead to errors.
  • Neuraceq is an adjunct to other diagnostic evaluations. A positive Neuraceq scan does not establish the diagnosis of Alzheimer’s disease or any other cognitive disorder.
  • Decisions regarding therapeutic interventions should be made based on the totality of the patient’s history. Safety and effectiveness of Neuraceq have not been established for monitoring responses to therapies.
  • Representations of medication history of patients in Case Studies are not representative of studies or recommendations of Life Molecular Imaging. These medication histories are representative of patients observed by Life Molecular Imaging, however Life Molecular Imaging does not recommend, and has not studied, these therapies. They are solely provided for contextual purposes.

Medical history

  • 3 major depressive episodes treated with psychiatric medications
  • Mildly positive family history (80-year-old father)
  • Hyperuricemia, rheumatoid arthritis
  • Diurnal sleepiness
  • Fluctuations of consciousness
  • Urinary incontinence
  • Neuroleptic hypersensitivity

Medications

  • Escitalopram, quetiapine, prednisone, lansoprazole, folinic acid
Etiology of cognitive impairment: likely due to Alzheimer’s disease
Medical treatment: acetylcholinesterase inhibitor

Neurocognitive exam

  • MMSE=13/30 – Parkinsonism

Test results

  • MRI scan
    • Mild generalized atrophy
    • Enlargement of temporal horn of lateral ventricles
    • No white matter changes
  • FDG-PET
    • Moderate hypometabolism in frontopolar, temporal, parieto-occipital regions
  • CSF
    • 42=700 pg/mL (v.n. >650 pg/mL)
    • Total tau=230 pg/mL (v.n. <400 pg/mL)
  • SPECT DaTscan: negative
  • EEG: normal

PET Beta-Amyloid Imaging Results

case-study-imaging-results-1

Diagnosis and Plan

Diagnosis

  • Cognitive impairment unlikely due to Alzheimer’s disease
  • Psychiatric disorder (major depression)

Therapy

  • Acetylcholinesterase inhibitor discontinued
  • Quetiapine reduced and discontinued
  • Trazodone initiated for insomnia
  • Sertraline initiated

Follow-up

  • 2 months: MMSE=17/30
  • 9 months: MMSE=29/30

Case Study 2

59-year-old man presenting for a second opinion for MCI due to AD

Disclaimer

  • The following case examples assume that interpretation of the beta-amyloid imaging PET data has been completed independently of the patient's clinical evaluation. The use of clinical information in the interpretation of Neuraceq images has not been evaluated and may lead to errors.
  • Neuraceq is an adjunct to other diagnostic evaluations. A positive Neuraceq scan does not establish the diagnosis of Alzheimer’s disease or any other cognitive disorder.
  • Decisions regarding therapeutic interventions should be made based on the totality of the patient’s history. Safety and effectiveness of Neuraceq have not been established for monitoring responses to therapies.
  • Representations of medication history of patients in Case Studies are not representative of studies or recommendations of Life Molecular Imaging. These medication histories are representative of patients observed by Life Molecular Imaging, however Life Molecular Imaging does not recommend, and has not studied, these therapies. They are solely provided for contextual purposes.

Medical history

  • Memory loss, apathy, and loss of interest for 1 year (following a demotion at work)
  • Negative family history
  • High socioeconomic status
  • No comorbidities
  • Diagnosis of MCI due to AD

Medications

  • Acetylcholinesterase inhibitor
Etiology of cognitive impairment: mild cognitive impairment possibly due to Alzheimer’s disease
Medical treatment: continuation of acetylcholinesterase inhibitor

Neurocognitive exam

  • MMSE=29/30 – normal neurological examination

Neuropsychological tests

  • Abnormal: verbal learning, visuospatial learning, constructional abilities

Test results

  • MRI scan
    • Moderate bilateral posterior cortical atrophy
    • Mild medial temporal lobe atrophy (Scheltens 1/4 2/4)
    • Nonsignificant white matter changes (Wahlund 3/30)
  • FDG-PET
    • Normal brain glucose metabolism
  • CSF
    • Aβ42=671 pg/mL (v.n. >650 pg/mL)

PET Beta-Amyloid Imaging Results

case-study-imaging-results-1

Diagnosis and Plan

Diagnosis

  • Cognitive impairment due to depression

Therapy

  • Acetylcholinesterase inhibitor discontinued
  • Sertraline initiated

Follow-up

  • At the first follow-up after 2 weeks, improvement of depressive symptoms

Case Study 3

76-year-old man with episodic memory loss for 2 years

Disclaimer

  • The following case examples assume that interpretation of the beta-amyloid imaging PET data has been completed independently of the patient’s clinical evaluation. The use of clinical information in the interpretation of Neuraceq images has not been evaluated and may lead to errors.
  • Neuraceq is an adjunct to other diagnostic evaluations. A positive Neuraceq scan does not establish the diagnosis of Alzheimer’s disease or any other cognitive disorder.
  • Decisions regarding therapeutic interventions should be made based on the totality of the patient’s history. Safety and effectiveness of Neuraceq have not been established for monitoring responses to therapies.
  • Representations of medication history of patients in Case Studies are not representative of studies or recommendations of Life Molecular Imaging. These medication histories are representative of patients observed by Life Molecular Imaging, however Life Molecular Imaging does not recommend, and has not studied, these therapies. They are solely provided for contextual purposes.

Medical history

  • Negative family history
  • High socioeconomic status
  • Sinus bradycardia
  • No depression or anxiety

Medications

  • Manidipine, low-dose aspirin, omega-3, tamsulosin

Neurocognitive exam

  • MMSE=26-30/30 – normal neurological exam
Etiology of cognitive impairment: possibly due to Alzheimer’s disease
Medical treatment: initiation of acetylcarnitine and piracetam

Neuropsychological tests

  • Abnormal: visuospatial learning, executive functions
  • Borderline: verbal learning, visuospatial short-term memory

Test results

  • MRI scan
    • Moderate bilateral temporal, parietal, occipital atrophy
    • No medial temporal lobe atrophy (Scheltens 1/4 0/4)
    • Nonsignificant white matter changes (Wahlund 2/30)
  • FDG-PET
    • Normal
    • PALZ score=4.412 (v.n. <11.090)
  • CSF
    • Aβ42=657 pg/mL (v.n. >650 pg/mL)
    • Total tau=579 pg/mL (v.n. <400 pg/mL)

PET Beta-Amyloid Imaging Results

case-study-imaging-results-1

Diagnosis and Plan

Diagnosis

  • Mild cognitive impairment likely due to Alzheimer’s disease

Therapy

  • Initiation of Souvenaid®

Follow-up

  • Under observation

 

 

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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 Events 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%).


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)
http://www.fda.gov/Safety/MedWatch/default.htm