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Study on the Benefits of Amyloid PET Imaging with Florbetaben (18F) and Flutemetamol (18F) for Patients with Various Types of Dementia

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the benefits of using a special type of brain scan called amyloid PET imaging for people with different types of dementia. Dementia is a condition that affects memory, thinking, and the ability to perform everyday activities. The study includes various forms of dementia, such as Alzheimer's disease, vascular dementia, and dementia related to other conditions like Parkinson's disease and HIV. The trial aims to see if amyloid PET imaging can provide better information compared to standard methods without this imaging.

Participants in the study will receive either the amyloid PET imaging or standard diagnostic procedures. The imaging involves using a solution for injection, such as Neuraceq or VIZAMYL, which contains substances like florbetaben (18F) or flutemetamol (18F). These substances help highlight certain areas of the brain during the scan. The study will observe how this imaging affects the management of daily activities and overall quality of life for those with dementia.

The trial will last for several weeks, with follow-up assessments to monitor changes in cognitive performance, quality of life, and any potential side effects. The goal is to determine if amyloid PET imaging can improve the understanding and treatment of dementia compared to current diagnostic methods. Participants will be monitored by healthcare professionals throughout the study to ensure their safety and well-being.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on criteria such as age, insurance coverage, and dementia diagnosis.

    Written informed consent is required, either by the patient or a legal representative.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the severity of dementia using tools like the Clinical Dementia Rating Scale and the Mini-Mental-Status Test.

    The assessment helps determine the suitability for amyloid PET imaging.

  3. Step 3

    Randomization

    Participants are randomly assigned to either the amyloid PET imaging group or the control group.

    Those in the amyloid PET group will undergo the imaging procedure.

  4. Step 4

    Amyloid PET imaging

    For those in the amyloid PET group, the imaging involves an intravenous injection of either Neuraceq or VIZAMYL solution.

    The procedure aims to provide a clearer diagnosis of dementia.

  5. Step 5

    Follow-up assessments

    Follow-up assessments occur at 26, 52, 78, and 104 weeks after randomization.

    These assessments measure cognitive performance, quality of life, and the need for care.

  6. Step 6

    Final evaluation

    A final evaluation is conducted to assess the ability to manage daily activities and any changes in dementia diagnosis.

    The evaluation also considers any adverse events experienced during the trial.

Who can join the trial?

11 criteria

  • Be at least 50 years old.
  • Have someone who can provide information about you, like a family member or friend.
  • Have valid health insurance from a German compulsory health insurance.
  • Have mild to moderate **dementia syndrome**. Dementia syndrome refers to a group of symptoms affecting memory, thinking, and social abilities.
  • Have a **Clinical Dementia Rating Scale (CDR)** score greater than 0.5 and less than 3.0. The CDR is a tool used to assess the severity of dementia.
  • Have a **Mini-Mental-Status Test (MMSE)** score greater than 10. The MMSE is a test that measures cognitive function.
  • Have an unclear diagnosis of dementia or uncertain diagnosis of Alzheimer's disease, meaning the certainty of the diagnosis is less than 85%.
  • Have a diagnosis of Alzheimer's disease with at least a 15% probability, meaning Alzheimer's disease cannot be completely ruled out.
  • Cannot have a diagnosis made by examining the **CSF** (cerebrospinal fluid) because: a) there is a medical reason not to do the CSF test, b) you refuse the CSF test, or c) the diagnosis is still unclear after the CSF test.
  • Be willing to undergo **amyloid PET** diagnostics and agree to know the result if selected for this part of the study. Amyloid PET is a type of brain scan used to detect amyloid plaques, which are associated with Alzheimer's disease.
  • Provide written informed consent, either by yourself or through a legal representative, based on what you would likely want.

Who cannot join the trial?

8 criteria

  • Patients with any type of dementia cannot participate. Dementia is a condition that affects memory, thinking, and social abilities.
  • Patients with Parkinson's disease who also have dementia are excluded. Parkinson's disease is a disorder that affects movement.
  • Patients with Alzheimer's disease of any type, including early or late onset, are not eligible. Alzheimer's disease is a common form of dementia.
  • Patients with vascular dementia are excluded. Vascular dementia is caused by problems in the blood supply to the brain.
  • Patients with HIV who have dementia cannot participate. HIV is a virus that attacks the immune system.
  • Patients with Pick's disease or Huntington's disease who have dementia are not eligible. These are rare brain disorders.
  • Patients with Creutzfeldt-Jakob disease who have dementia are excluded. This is a rare, degenerative brain disorder.
  • Patients with any other specified diseases that cause dementia are not eligible.
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Investigated drugs

Amyloid PET Imaging is a type of brain scan used in this clinical trial to help detect amyloid plaques, which are associated with Alzheimer's disease and other forms of dementia. The goal of using this imaging technique is to provide a clearer picture of the brain's condition, potentially leading to better diagnosis and treatment planning for patients with dementia.

What is already known about the treatment

Amyloid PET Imaging – This diagnostic tool is administered through a specialized imaging procedure known as positron emission tomography (PET). It is currently being evaluated in clinical trials to assess its benefits in diagnosing various types of dementia, including Alzheimer's disease and other related conditions. The main therapeutic indication is to improve the accuracy of dementia diagnosis by detecting amyloid plaques in the brain, which are associated with Alzheimer's disease. At the molecular level, amyloid PET imaging works by using a radioactive tracer that binds to amyloid plaques, allowing them to be visualized on the PET scan. This method falls under the pharmacological classification of diagnostic radiopharmaceuticals.

Investigated diseases

  • Dementia in Parkinson disease

    This condition occurs in individuals with Parkinson's disease, characterized by a decline in cognitive abilities such as memory, attention, and problem-solving. It typically progresses gradually, with symptoms worsening over time. Patients may experience difficulties with daily activities and changes in mood or behavior.

  • Dementia in Alzheimer disease, atypical or mixed type

    This form of dementia involves symptoms that do not fit the typical pattern of Alzheimer's disease, often including a mix of cognitive impairments. It progresses with a decline in memory, language, and other cognitive functions, affecting the ability to perform everyday tasks.

  • Vascular dementia, unspecified

    This type of dementia is caused by problems in the blood supply to the brain, leading to cognitive decline. The progression can vary, with symptoms such as confusion, disorientation, and difficulty with concentration and communication.

  • Multi-infarct dementia

    This condition results from multiple small strokes that cause damage to brain tissue, leading to a decline in cognitive abilities. It progresses in a stepwise manner, with sudden changes in symptoms following each stroke.

  • Dementia in other specified diseases classified elsewhere

    This category includes dementia associated with various other medical conditions. The progression and symptoms depend on the underlying disease but generally involve a decline in cognitive functions.

  • Dementia in Alzheimer disease with late onset

    This form of Alzheimer's disease begins after the age of 65 and is characterized by a gradual decline in memory and cognitive abilities. It progresses slowly, affecting daily living activities and social interactions.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503705-10-00Protocol codePETAD01Estimated enrolment1 126 patientsSponsorDeutsches Zentrum Fuer Neurodegenerative Erkrankungen e.V.

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