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Study on the Use of Flortaucipir for Diagnosing Mild Cognitive Impairment and Dementia in Patients

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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 mild cognitive impairment and dementia, which are conditions that affect memory and thinking skills. The study will use a treatment called Flortaucipir, also known by its code name LY3191748. Flortaucipir is a solution for injection that helps in imaging the brain to detect abnormal protein deposits associated with these conditions. The purpose of the study is to evaluate how well this imaging technique, known as tau PET, can improve the accuracy of diagnosing these memory-related conditions and enhance patient care.

Participants in the study will undergo a tau PET scan, which is a type of imaging test that helps doctors see changes in the brain. This test will be compared to other diagnostic methods to see if it provides better information. The study will look at how the use of tau PET affects the diagnosis, the confidence of doctors in their diagnosis, and the management of the patient's condition. It will also assess how this imaging technique impacts the patient's wellbeing, including their levels of anxiety and uncertainty.

The study will also explore how tau PET compares to new blood tests and artificial intelligence tools in diagnosing these conditions. The goal is to see if tau PET can offer a more reliable way to understand and manage mild cognitive impairment and dementia, ultimately improving the care and quality of life for patients with these conditions.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit

    Upon joining the study, you will have an initial visit where the study team will explain the trial process and answer any questions you may have.

    You will be asked to provide informed consent, confirming your understanding and willingness to participate in the study.

  2. Step 2

    Screening and baseline assessments

    You will undergo a series of assessments to confirm your eligibility for the study. These assessments include basic cognitive screening tests and an MRI scan.

    The study team will review your medical history and current health status to ensure you meet the study criteria.

  3. Step 3

    Tau PET scan

    You will receive an injection of a solution called flortaucipir, which is used to perform a tau PET scan. This scan helps to visualize certain proteins in the brain.

    The injection is administered through an intravenous bolus injection or IV infusion. The scan will help the study team assess the presence of tau proteins, which are associated with cognitive impairment.

  4. Step 4

    Follow-up assessments

    After the tau PET scan, you will have follow-up assessments to evaluate any changes in your diagnosis and management.

    These assessments will help determine the impact of the tau PET scan on your diagnosis and treatment plan.

  5. Step 5

    Final evaluation

    At the end of the study period, you will have a final evaluation to assess your overall wellbeing and any changes in your condition.

    The study team will compare your pre- and post-scan results to evaluate the effectiveness of the tau PET scan as a diagnostic tool.

Who can join the trial?

5 criteria

  • Patients must be 50 years or older.
  • Patients should be in the prodromal stage (also known as mild cognitive impairment or MCI), where they have some memory or thinking problems, or in the mild dementia stage, where they have a Clinical Dementia Rating (CDR) score of 1.
  • Patients must have completed a routine work-up, which includes basic memory and thinking tests and an MRI scan (a type of brain imaging) with a specific 3D sequence.
  • There should be substantial diagnostic uncertainty after routine dementia screening. This means there is less than 85% certainty about the diagnosis due to reasons like mixed types of brain changes, unusual symptoms, or conflicting results from other tests like MRI or cerebrospinal fluid (CSF) tests. Alzheimer's disease (AD) should be considered as a possible diagnosis.
  • Patients must be able to tolerate study procedures (only for those participating in the tau PET scan) and be able to make a well-informed decision to participate, as judged by their neurologist.

Who cannot join the trial?

8 criteria

  • Patients with any other serious medical condition that could interfere with the study.
  • Patients who are unable to undergo a PET scan. A PET scan is a type of imaging test that helps doctors see how your tissues and organs are functioning.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had a significant head injury in the past year.
  • Patients with a history of drug or alcohol abuse in the past year.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a known allergy to any of the substances used in the study.
  • Patients who have a mental health condition that could interfere with their ability to participate in the study.
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Investigated drugs

The clinical trial titled "The clinical value of tau PET in the memory clinic (TAP-TAU)" is focused on assessing the value of tau PET as a diagnostic tool. However, the provided data does not include specific medications or therapies involved in the trial. Therefore, I am unable to list any medications or therapies based on the given information.

What is already known about the treatment

Tau PET – Tau PET is a diagnostic imaging tool used in the form of a scan to help identify changes in the brain associated with mild cognitive impairment and dementia. It is currently being studied in clinical trials to determine its effectiveness in improving diagnostic accuracy and patient management. The main therapeutic indication for Tau PET is to assist in diagnosing conditions related to memory loss and cognitive decline. At the molecular level, Tau PET works by detecting abnormal tau protein deposits in the brain, which are often linked to neurodegenerative diseases. It is classified as a diagnostic imaging agent rather than a traditional medication.

Investigated diseases

  • Mild Cognitive Impairment

    Mild Cognitive Impairment (MCI) is a condition characterized by noticeable changes in cognitive abilities, such as memory and thinking skills, that are greater than expected for a person's age but do not interfere significantly with daily life. Individuals with MCI may experience forgetfulness, difficulty in finding words, or trouble with complex tasks. The progression of MCI can vary; some individuals may remain stable or even improve, while others may progress to more severe forms of cognitive decline. MCI is often considered an intermediate stage between normal cognitive aging and dementia. It is important to monitor cognitive changes over time to understand the progression of the condition.

  • Dementia

    Dementia is a general term for a decline in mental ability severe enough to interfere with daily life. It involves a deterioration in memory, thinking, behavior, and the ability to perform everyday activities. The progression of dementia is typically gradual, with symptoms worsening over time. Early stages may involve mild memory loss and confusion, while later stages can lead to significant impairment in communication, reasoning, and personal care. Dementia is caused by damage to brain cells, which affects their ability to communicate with each other. The most common type of dementia is Alzheimer's disease, but there are other forms, including vascular dementia and Lewy body dementia.

Trial detailsLast updated 7 Oct 2026
Age65+ yearsPhasePhase IVTrial ID2023-505430-10-00Estimated enrolment360 patientsSponsorAmsterdam UMC Stichting

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