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Study on Sleep and Temperature Changes in Alzheimer’s Disease for Down Syndrome Patients Using Izaflortaucipir (18F)

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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 relationship between sleep disorders and changes in body temperature as potential risk factors for the progression of Alzheimer's disease in individuals with Down syndrome. The study involves the use of a special imaging agent called [18F]PI-2620, which is a solution for injection. This agent helps in visualizing certain brain changes associated with Alzheimer's disease.

The purpose of the study is to understand how sleep and body temperature might influence the development of Alzheimer's disease in people with Down syndrome. Participants will receive an injection of the imaging agent [18F]PI-2620 through a slow injection into a vein. This will allow researchers to take detailed images of the brain using a technique called magnetic resonance imaging (MRI). These images will help in assessing changes in the brain over time.

The study will follow participants over a period to observe any changes in their brain structure and function. The information gathered from this study could provide valuable insights into how sleep and body temperature affect Alzheimer's disease progression in individuals with Down syndrome. Participants will be monitored for any changes in their condition, and the results will contribute to a better understanding of these complex interactions.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes verifying the diagnosis of Down syndrome and ensuring there is no acquired cognitive impairment.

    A series of neuropsychological evaluations will be performed to assess intellectual abilities and general health status.

  2. Step 2

    Baseline imaging

    A baseline imaging session will be scheduled. This involves an MRI scan to capture detailed images of the brain structure.

    The [18F]PI-2620 solution will be administered through an intravenous slow bolus injection to help visualize specific brain regions.

  3. Step 3

    Follow-up assessments

    Regular follow-up assessments will be conducted to monitor changes over time. These assessments will include additional neuropsychological evaluations and imaging sessions.

    The frequency and duration of these follow-up assessments will be determined by the study protocol and communicated during the trial.

  4. Step 4

    Final evaluation

    At the end of the study period, a final evaluation will be conducted. This will include a comprehensive review of all collected data, including imaging and neuropsychological results.

    The final evaluation aims to assess the relationship between sleep disorders, body temperature variations, and the progression of Alzheimer's disease in individuals with Down syndrome.

Who can join the trial?

6 criteria

  • People with Down syndrome who are between 40 and 60 years old.
  • Both men and women can participate.
  • Participants should have mild to moderate intellectual disabilities, which means they may have some learning difficulties but can still understand and follow instructions.
  • A confirmed diagnosis of Down syndrome through karyotyping, which is a test that looks at the chromosomes in cells.
  • Participants should not have any additional cognitive impairments, which means no extra problems with thinking, memory, or understanding, as shown by special tests called neuropsychological evaluations.
  • Participants should be in good general health, meaning they do not have any serious illnesses or conditions that could affect their overall well-being.

Who cannot join the trial?

4 criteria

  • Patients who do not have a diagnosis of Alzheimer's Disease cannot participate.
  • Patients who do not have Down Syndrome cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
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Investigated drugs

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Investigated diseases

  • Alzheimer's Disease

    Alzheimer's disease is a progressive neurological disorder that leads to the degeneration of brain cells. It primarily affects memory, thinking, and behavior. The disease typically begins with mild memory loss and confusion, which gradually worsen over time. As it progresses, individuals may experience difficulties with language, disorientation, mood swings, and impaired judgment. In advanced stages, individuals may lose the ability to carry out daily activities and recognize loved ones. The progression of Alzheimer's disease varies among individuals, but it generally leads to significant cognitive decline.

  • 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, upward slanting eyes, and a single deep crease across the palm. Individuals with Down syndrome often experience mild to moderate intellectual disability. The condition can also be associated with various health issues, including heart defects and thyroid problems. Developmental milestones, such as walking and talking, may be delayed. The progression of Down syndrome varies, with some individuals achieving a high level of independence and others requiring lifelong support.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-506609-21-00Protocol codeIIBSP-DOW-2022-150Estimated enrolment60 patientsSponsorFundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau

sourced from the EU Clinical Trials Register and site verification

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