Not recruiting

A study comparing [18F]SynVesT-1 and [18F]flortaucipir to measure synaptic density and tau protein levels in patients with Alzheimer's disease

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 research study focuses on Alzheimer's disease, a condition that affects memory and thinking abilities. The study will use two imaging substances: 18F-Synvest-1 and Flortaucipir, which are special solutions given through an injection into a vein. These substances help create detailed pictures of specific changes in the brain that are associated with Alzheimer's disease.

The purpose of this study is to measure two important features in the brain of people with Alzheimer's disease: the density of connections between brain cells (called synapses) and the presence of abnormal protein deposits (called tau). Both substances will be administered as an injection into a vein, with each injection containing a precisely measured amount of the imaging substance.

During the study, participants will receive these special imaging substances that allow doctors to see detailed pictures of their brain. The substances help show how brain cells are connecting with each other and where abnormal protein deposits might be located in the brain. This information will help researchers better understand how Alzheimer's disease affects the brain.

The research process

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

Step 1
Initial PET scan with first tracer
You will receive an intravenous injection of 18F-Synvest-1, a substance that helps visualize synaptic density in your brain
A PET scan (special brain imaging) will be performed to measure brain activity patterns
The entire procedure takes approximately 2 hours
Step 2
Break period
A mandatory waiting period between scans is required to ensure the first tracer has completely cleared from your body
Step 3
Second PET scan with different tracer
You will receive an intravenous injection of Flortaucipir, a substance that helps visualize tau protein accumulation in your brain
Another PET scan will be performed to measure tau protein patterns
The entire procedure takes approximately 2 hours
Step 4
Study completion
After completing both scans, your participation in the study is finished
The study will analyze the relationship between synaptic density and tau protein in your brain
The total study period runs from April 2024 to April 2026

Who can join the trial?

8 criteria

Must be at least 50 years old
Must have positive biomarker evidence (through CSF or PET scan) showing the presence of amyloid beta (Aβ) protein buildup in the brain (CSF is cerebrospinal fluid - the clear liquid that surrounds the brain and spinal cord; PET is a special type of medical imaging scan)
Must be able to understand and complete all study procedures, as determined by the neurologist
Must be mentally capable of making an informed decision about participating in the study
Must sign the informed consent form for the study
Can be either male or female
Must be able to undergo brain imaging procedures
Must be willing to participate in all required study visits and assessments

Who cannot join the trial?

14 criteria

Any neurological disorders other than Alzheimer's disease (conditions affecting the brain and nervous system)
Current participation in other clinical trials or use of investigational drugs
History of severe allergic reactions to medications
Inability to undergo MRI or PET scans (medical imaging procedures)
Significant heart, liver, or kidney disease
Current alcohol or substance abuse
Pregnancy or breastfeeding
Major psychiatric disorders requiring hospitalization in the past year
Use of certain medications that could interfere with brain imaging
Severe claustrophobia (fear of enclosed spaces) that would prevent imaging procedures
Presence of metal implants or devices incompatible with MRI
Inability to provide informed consent
History of brain surgery or significant head trauma
Severe vision or hearing impairments that would interfere with testing

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Verified sites

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Amsterdam UMC
Responsive
Amsterdam, The Netherlands

Trial locations

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Investigated drugs

Based on the provided trial data, the study involves two radioactive tracers used in brain imaging: SynVesT-1 is a radioactive imaging agent that helps doctors see and measure synaptic density (the connections between brain cells) in the brain. It is labeled with fluorine-18 and used during PET scans to help evaluate brain function, particularly in people with Alzheimer's disease. Flortaucipir is a radioactive imaging agent that binds to tau protein deposits in the brain. When used in PET scans, it helps doctors visualize the buildup of abnormal tau proteins, which is one of the hallmarks of Alzheimer's disease. This allows researchers to study the progression of the disease and evaluate potential treatments.

What is already known about the treatment

Flortaucipir
A radioactive diagnostic agent administered via intravenous injection, used specifically in positron emission tomography (PET) imaging to detect tau protein deposits in the brains of patients being evaluated for Alzheimer's disease. This specialized imaging tracer binds to abnormal tau protein aggregates in the brain, allowing doctors to visualize the distribution and density of tau tangles, which are characteristic markers of Alzheimer's disease progression. Currently approved by regulatory authorities and widely documented in medical literature, this diagnostic tool helps in the accurate assessment of Alzheimer's disease pathology and belongs to the radiopharmaceutical class of medications.
SynVesT-1
An investigational radioactive imaging agent administered through intravenous injection, designed to measure synaptic density in the brain using PET scanning technology. This novel tracer specifically binds to synaptic vesicle protein 2A (SV2A), enabling visualization and quantification of synaptic density, which is particularly important in understanding neurodegeneration in Alzheimer's disease. Currently in clinical trials, this diagnostic tool represents a new approach to measuring brain connectivity and neuronal health, belonging to the radiopharmaceutical class of diagnostic agents.

Investigated diseases

Alzheimer's disease - A progressive brain disorder that gradually destroys memory, thinking skills, and the ability to carry out simple tasks. The disease begins slowly and gets worse over time, affecting areas of the brain that control thought, memory, and language. It causes brain cells to degenerate and die, leading to a steady decline in memory and mental function. Changes in the brain begin years before the first symptoms appear, with abnormal protein deposits forming throughout the brain. As more brain cells die, affected individuals gradually lose their ability to engage and communicate with others. The disease primarily affects older adults, though younger people can also develop it.