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Study on the Use of 18F-PI-2620 to Detect Alzheimer's in People with Down Syndrome

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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 Alzheimer's disease and Down syndrome. The treatment being tested is a special imaging agent called [18F]PI-2620, which is a solution for injection. This agent is used in a type of brain scan called Positron Emission Tomography (PET) to help detect certain changes in the brain associated with these conditions.

The purpose of the study is to gather information on how well [18F]PI-2620 works in identifying tau protein build-up in the brain, which is linked to Alzheimer's disease in people with Down syndrome. The study will also look at the safety of this imaging agent in both healthy individuals and those with Down syndrome. Participants will receive the injection of [18F]PI-2620 and then undergo a PET scan to see how the agent highlights areas of the brain affected by tau protein.

Throughout the study, participants will be monitored for any side effects for 24 hours after receiving the injection. The study aims to provide valuable insights into the use of [18F]PI-2620 for better understanding and potentially diagnosing Alzheimer's disease in individuals with Down syndrome over time.

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, the participant will be required to understand and accept the study procedures. This includes signing an informed consent form, which may be done by the participant or their guardian.

  2. Step 2

    Initial assessment

    Participants will undergo an initial assessment to ensure they meet the study's inclusion criteria. This includes being over 35 years of age, having no cognitive complaints, and achieving a certain score on neuropsychological tests.

  3. Step 3

    Administration of tracer

    The participant will receive an intravenous injection of the tracer [18F]PI-2620. This is a solution specifically designed for injection into the bloodstream.

  4. Step 4

    Imaging procedure

    After the injection, images will be taken using a technique called positron emission tomography (PET). This will occur within 90 minutes of the tracer administration. The images will help measure the presence of tau protein aggregates in the brain.

  5. Step 5

    Monitoring for adverse effects

    Participants will be monitored for any adverse effects for 24 hours following the administration of the tracer. This is to ensure the safety of the participant throughout the study.

  6. Step 6

    Follow-up assessments

    Participants may be required to return for follow-up assessments to measure the efficacy of the tracer over time. These assessments will help gather information on the tracer's ability to detect tau pathology associated with Alzheimer's disease in individuals with Down syndrome.

Who can join the trial?

8 criteria

  • Men and women who are older than 35 years.
  • No complaints about memory or thinking abilities.
  • Normal results on a thinking and memory test called the MMSE, with scores between 24 and 30. This means no memory problems or memory loss. Another test, the Free and Cued Selective Reminding Test (FCSRT), should have a score of 8 or higher. A score of 0 on the Clinical Dementia Rating (CDR) scale is also required, which means no signs of dementia.
  • Understanding and agreeing to the study procedures, and signing a consent form. This can be done by the patient or their guardian.
  • For participants with Down Syndrome (DS): Men and women diagnosed with DS who are older than 35 years.
  • For participants with DS: An intelligence quotient (IQ) higher than 34, which means mild to moderate intellectual disability.
  • For participants with DS: Having a reliable person who knows them well to provide information.
  • For participants with DS: Participants or their legal guardians must sign a consent form to join the study.

Who cannot join the trial?

2 criteria

  • Patients with a diagnosis of Alzheimer's disease cannot participate.
  • Patients with Down Syndrome are not eligible.
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Investigated drugs

18F-PI-2620 is a special type of imaging agent used in a medical scan called a PET scan. This agent helps doctors see certain proteins in the brain that are linked to Alzheimer's disease, especially in people with Down syndrome. The purpose of using this agent in the study is to find out how well it can detect these proteins over time and to ensure it is safe for both healthy individuals and those with Down syndrome. By using this agent, doctors hope to better understand the changes happening in the brain and improve the diagnosis and monitoring of Alzheimer's disease in these patients.

What is already known about the treatment

18F-PI-2620 – This medication is administered as an injection and is used in a specialized imaging technique called positron emission tomography (PET) to help visualize certain brain changes. It is currently being studied in clinical trials to understand its effectiveness in detecting tau protein build-up in the brains of people with Alzheimer's disease and Down syndrome. The main purpose of this medication is to help doctors see tau pathology, which is a hallmark of these conditions, and to ensure it is safe for use in both healthy individuals and those with Down syndrome. At the molecular level, 18F-PI-2620 binds to tau proteins, allowing them to be seen on PET scans, which helps in diagnosing and understanding the progression of these diseases. This medication falls under the category of diagnostic radiopharmaceuticals, which are substances used to diagnose medical conditions through imaging techniques.

Investigated diseases

  • Alzheimer disease

    Alzheimer disease is a progressive neurological disorder that leads to the degeneration of brain cells. It primarily affects memory, thinking, and behavior. The disease progresses through stages, starting with mild memory loss and confusion. As it advances, individuals may experience difficulty in recognizing familiar people, performing daily tasks, and communicating. In later stages, individuals may lose the ability to respond to their environment and require full-time care. The progression of symptoms varies among individuals.

  • Down Syndrome

    Down Syndrome is a genetic disorder caused by the presence of an extra chromosome 21. It is characterized by developmental delays and physical features such as a flat facial profile and upward slanting eyes. Individuals with Down Syndrome may experience mild to moderate intellectual disability. The condition can also be associated with various health issues, including heart defects and thyroid problems. Developmental milestones are typically reached at a slower pace compared to peers. The degree of progression and associated health challenges can vary widely among individuals.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515574-27-00Protocol codeIIBSP-FPI-2019-108Estimated enrolment80 patientsSponsorFundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau

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