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Using [18F]DED PET imaging to study brain changes in patients with Alzheimer's disease, CADASIL, and other forms of dementia.

Verified siteInvestigationalNo placebo
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What is this trial about?

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

This study focuses on understanding brain changes in people living with various forms of Dementia, which is a group of symptoms that affect memory, thinking, and social abilities. The research includes specific types of the condition such as Alzheimer's Disease, including cases that are Autosomal Dominant Alzheimer's Disease, Late onset Alzheimer Disease, and Sporadic early onset Alzheimer Disease. Additionally, the study involves individuals with CADASIL, a rare genetic condition that affects the small blood vessels in the brain. The primary goal is to investigate how certain brain cells called astrocytes react during the progression of these diseases.

To observe these changes, a specialized imaging technique called PET, or positron emission tomography, will be used. During the process, a substance known as [18F]DED will be administered through an intravenous injection, which means it is delivered directly into a vein. This substance acts as a tracer that allows doctors to see specific activities in the brain through medical scans. This imaging process helps to identify how the brain cells are behaving in different stages of neurodegenerative diseases, which are conditions where the nervous system gradually declines over time.

The research process

The trial runs in 1 step.

  1. Step 1

    Brain imaging scan

    An intravenous bolus injection, which is a single dose of medicine delivered directly into a vein, is administered. the substance used is [18F]DED, a specialized liquid for injection.

    The dose of [18F]DED is 240,000,000 becquerels (a unit used to measure radioactivity).

    A pet scan, which is a type of imaging used to observe how tissues and organs function, is performed to study changes in the brain.

Who can join the trial?

6 criteria

  • You or your legal representative must provide written informed consent, which is a formal document signed to show you agree to take part in the study.
  • You must be a man or a woman who has already been part of the specific group of people being studied in Barcelona.
  • You must be between 18 and 99 years old at the time you join the study group.
  • You must have a cerebral MRI (a type of medical imaging used to look at the structure of the brain) taken within the last 18 months, or you must be willing to have a new one performed for the study.
  • Your cognitive status (your level of mental function, such as memory, thinking, and reasoning) must have been evaluated as part of the previous study group, ideally within the last 12 months.
  • You must have a good understanding of either Spanish or Catalan.

Who cannot join the trial?

17 criteria

  • You are a current or active smoker.
  • You have a history of encephalitis (inflammation of the brain), ictus (a sudden medical event such as a stroke), or seizures (sudden electrical disturbances in the brain), though childhood convulsions caused by fever are not an exclusion.
  • A brain scan called an MRI shows serious unexpected issues, such as severe macrovascular disease (significant damage to large blood vessels in the brain, often from multiple strokes) or a brain tumor (an abnormal growth of cells in the brain).
  • You have participated in a clinical study using a new experimental medicine within the last 30 days, or a study using a radioactive tracer within a specific timeframe determined by the drug's half-life (the time it takes for half of the substance to leave your body).
  • You have significant renal insufficiency (kidney problems) or hepatic insufficiency (liver problems), which are identified through specific blood test results for liver enzymes and kidney filtration rates.
  • You have any other health condition that could make the study unsafe or interfere with the results.
  • You have a known allergy or hypersensitivity (an extreme immune reaction) to any of the ingredients used in the study products.
  • You have implants or devices that cannot be used inside an MRI machine, such as pacemakers (devices to control heart rhythm), defibrillators, cochlear implants (devices to help with hearing), or pieces of metal in the body.
  • Your body size or weight prevents you from safely using the MRI scanner.
  • You have an active drug or alcohol abuse problem.
  • You have had a bad reaction or intolerance to previous PET studies (a type of imaging scan that uses a radioactive substance to show how organs are working).
  • You are a woman of childbearing potential (able to become pregnant) and are not using a highly effective form of contraception (birth control), or you have not had a negative pregnancy test.
  • You are currently pregnant or breast-feeding.
  • You are unable to lie flat on your back in a supine position for 60 minutes.
  • You are taking any MAO-B inhibitors, which are a specific type of medication often used to treat certain neurological conditions.
  • You have a psychiatric disorder (a mental health condition) such as major depressive disorder, generalized anxiety disorder, schizophrenia, or bipolar disorder.
  • You have significant visual impairment (problems with seeing) or hearing impairment (problems with hearing).
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Investigated drugs

[18F]DED is a specialized substance injected into the bloodstream that is used during a PET scan. It works as a tracer to help doctors and researchers see and study how certain brain cells, called astrocytes, react in people with neurodegenerative diseases like Alzheimer's.

What is already known about the treatment

[18F]DED - This substance is an injectable liquid that is delivered directly into a person's vein through a single injection or a slow drip. Currently used as a specialized research tool in medical imaging, it is being studied to help doctors see changes in brain cells during scans. It works by traveling to specific areas of the brain where brain cells become active or irritated, allowing them to be highlighted on a PET scan. This tool is classified as a radioactive imaging agent used to help understand conditions like dementia and Alzheimer's disease.

Investigated diseases

  • Dementia

    This condition involves a decline in mental abilities that interferes with daily life. It typically starts with mild memory loss or confusion. Over time, the impairment spreads to other cognitive functions such as reasoning and language. The process generally involves a gradual loss of brain cell connections.

  • Cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy

    This is a genetic disorder that affects the small blood vessels in the brain. It is characterized by repeated small strokes and damage to the white matter of the brain. The condition often progresses through stages of worsening cognitive and physical functions. It is caused by mutations in specific genes that impact blood vessel health.

  • Late onset Alzheimer Disease

    This is a progressive brain disorder that typically affects older adults. It begins with subtle changes in memory and thinking. As the disease advances, it impacts various cognitive processes and behaviors. The damage to brain cells increases steadily over time.

  • Autosomal Dominant Alzheimer's Disease

    This is a rare form of the disease that is passed down through families via a specific genetic mutation. It often begins at an earlier age compared to other forms. The disease involves the accumulation of certain proteins in the brain. It progresses through a continuous decline in cognitive abilities.

  • Sporadic early onset Alzheimer Disease

    This condition refers to the disease occurring in younger individuals without a clear family history of the disorder. It involves the gradual loss of brain cells and their connections. The symptoms typically emerge as a decline in memory and cognitive skills. The progression follows a pattern of worsening neurological function over time.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-523284-37-00Protocol codeAstrocyte-PET/BBRCEstimated enrolment300 patientsSponsorBarcelonabeta Brain Research Center

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