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What is AD

About AD

Alzheimer’s Disease (AD), an insidious neurodegenerative ailment, unfolds with a clandestine onset and progressive deterioration, comprising preclinical, mild cognitive impairment (MCI), and dementia stages. During the preclinical phase, patients typically manifest no overt cognitive decline or merely exhibit subjective cognitive descent. In the MCI stage, patients begin to experience cognitive impairments, particularly in memory. In the dementia stage, individuals gradually forfeit fundamental life capabilities, profoundly impacting the mental and physical well-being of the middle-aged and elderly, imposing a substantial burden on families and society.

With the ongoing escalation of population aging in China, the populace of AD patients is rapidly proliferating. A 2022 report from the international medical journal “The Lancet Public Health” reveals that there are presently approximately 10 million AD patients in China, with an anticipated surge to 30 million by 2030. Due to the limited awareness of the disease among patients and their families, coupled with the constrained diagnostic methods offered by hospitals, numerous patients are unable to receive timely diagnosis and treatment.

Urgent measures are to needed enhance the diagnosis and treatment of AD in response to the escalating burden of the disease in China, compounded by low rates of diagnosis and treatment.

What is AD

Six Stages of the AD Progression

The abnormal deposition of β-amyloid neuritic plaques in the brain is the earliest pathological change in Alzheimer’s Disease (AD) and serves as a core biomarker for AD. Clinical practice often involves PET-CT/PET-MRI scans to detect the level of Aβ deposition in the brain, enabling the diagnosis, differential diagnosis, and efficacy assessment of AD.

The progression of AD comprises six stages. In the first two stages, there are no apparent cognitive decline symptoms, making it challenging to identify. It is noteworthy that, during this period, β-amyloid neuritic plaques deposition is already present in the brain. As the disease advances and noticeable symptoms emerge in stages 3, 4, 5, and 6, Aβ deposition in the brain may have been occurring for up to 20 years.

 

Alzheimer’s disease (AD)course – six stages (2018 NIA-AA)

AD has the characteristics of insidious onset and irreversible disease progression. Early diagnosis and intervention of the disease are the key to controlling disease progression.

 

Accurate diagnostic tool

It was demostrated that florbetaben F 18 injection is an accurate diagnostic tool for the estimation of beta-amyloid neuritic plaque in the living brain.

Only Active for a Short time

Florbetaben F 18 injection 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 florbetaben F 18 injection use have been reported. All side effects wre mild to moderate and of short duration.

What is Florbetaben F 18 Injection

Florbetaben F 18 injection（with English trademark Neuraceqr®, and Chinese trademark 欧韦宁®) is the first domestically approved Aβ-PET imaging agent used for Alzheimer’s disease diagnosis.

Florbetaben F 18 is an 18F-labeled diphenylethene derivative capable of specific binding to β-amyloid neuritic plaques in the cerebral cortex. The positron signals generated by the 18F isotope can be visualized through positron emission tomography (PET) scans, providing a direct depiction of the presence and spatial distribution of β-amyloid neuritic plaques in the brain.

Florbetaben F 18 injection is the first domestically approved Aβ-PET imaging agent for Alzheimer’s disease (AD) diagnosis. It enables early, precise, and non-invasive diagnosis of AD, addressing a gap in the domestic market.

PET SCAN

Advantages of PET scanning

PET scans are typically combined with CT scans to enhance diagnostic accuracy. Compared to traditional imaging, PET/CT scans using Florbetaben F 18 injection can provide clear images of β-amyloid plaques, aiding both the subject and the clinician in making more precise treatment decisions.
Before PET SCAN

Checklist

The examinee should opt for comfortable clothing, avoiding garments with metal accessories, jewelry, glasses, etc., which must be removed before the examination.

It is essential for the examinee to bring a list of all currently taken medications and share their medical history with the doctor.

During PET SCAN

workflows

A florbetaben F 18 injection 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 florbetaben F 18 injection move more quickly through the bloodstream.

  • Injection——the florbetaben F 18 injection injection is given through an iv(intravenous) tube.
  • 45+Minutes——the florbetaben F 18 injection PET scan can be done 45 to 130 minutes after injection and usually lasts 15 to 20 minutes.
  • 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, an nuclear mdicine imaging specialist will view the results write a report, and send it to your doctor.
After PET SCAN

Outcome

The examinee should bring the examination reports for the clinician to review and make a diagnosis. The doctor will assess the results of the patient’s PET scan and other examinations, combining them with clinical manifestations, to determine whether the cognitive impairment in the patient may be attributed to Alzheimer’s Disease.

The negative or positive scan results can assist both patients and physicians in clarifying the underlying causes.

A positive scan

If the florbetaben F 18 injection 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.

A Negative scan

If the florbetaben F 18 injection PET scan is negative, your doctor may consider different causes of cognitive impairment that are not due to AD.

 
 
 
Patient Support

How to communicate with your doctor

Notes on appointment and scanning of florbetaben F 18 injection
It’s advisable to have a relative or friend accompany you for the appointment and examination.
Please provide a list of all medications you are currently taking, along with essential medical history.

Come up with a list of questions you may have for the doctor.

  • Can you talk to me about PET / CT scans and their safety?
  • Is a PET / CT scan with florbetaben F 18 injection the best choice for me?
  • What did my florbetaben F 18 injection PET scan show?
  • What do my results mean?
  • What else do you recommend?
Patient Support

Frequently Asked Questions about Florbetaben F 18 injection

Who is florbetaben F 18 injection for?

Florbetaben F 18 injection 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.

Does florbetaben F 18 injection diagnose Alzheimer’s disease?

Your doctor will make a diagnosis based on the results of the Florbetaben F 18 injection PET scan, along with other examinations and observations. A negative florbetaben F 18 injection 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 florbetaben F 18 injection 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. Florbetaben F 18 injection is an adjunct to other diagnostic evaluations.

Limitations of Use

  • A positive florbetaben F 18 injection scan does not establish the diagnosis of AD or any other cognitive disorder.
  • Safety and effectiveness of florbetaben F 18 injection have not been established for the follwing aspects.
    • Predicting development of dementia or other neurologic conditions
    • Monitoring responses to therapies.

What are some of the benefits of getting a florbetaben F 18 injection PET scan?

Florbetaben F 18 injection 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.

Does a florbetaben F 18 injection PET scan suits me？

Only your doctor can determine if a florbetaben F 18 injection PET scan is appropriate for you.

What are the important safety information of florbetaben F 18 injection?

  • Risk for Image Misinterpretation and Other Errors
    Errors may occur in the florbetaben F 18 injection estimation of brain neuritic β-amyloid plaque density during image interpretation. Image interpretation should be performed independently of the patient’s clinical information. The use of clinical information in the interpretation of florbetaben F 18 injection 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 florbetaben F 18 injection scan. Errors may also occur due to motion artifacts that result in image distortion. Florbetaben F 18 injection 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
    Florbetaben F 18 injection, 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.
  • Overdosage
    A pharmacological overdose of florbetaben F 18 injection is unlikely given the relatively low doses used for diagnostic purposes. In the event of administration of a radiation overdose with florbetaben F 18 injection, the absorbed organ dose to the patient should be reduced by increasing elimination of the radionuclide from the body by inducing frequent micturition.
 

Important Information of Florbetaben F 18 Injection

Early diagnosis

Guidelines and consensus consistently recommend the use of beta-amyloid PET detection for early diagnosis and differential diagnosis of Alzheimer’s Disease (AD).
 
  • Beta-amyloid PET serves as a core biomarker in the imaging examination of AD.
  • Positive imaging results have been observed as early as 15-20 years before the onset of dementia symptoms.

Accurate

Florbetaben F 18 injection, through detection, precisely identifies beta-amyloid plaques in AD patients.
  • High sensitivity and specificity.
  • Reveals the pathological spatial distribution.
  • Facilitates visual qualitative interpretation.

Non-invasive

The detection method of Florbetaben F 18 injection is non-invasive and highly practical, avoiding discomfort and potential complications associated with invasive procedures.