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Study on Neurodegenerative Diseases Using [18F]RO6958948 for Early Detection and Mapping in At-Risk Patients

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 clinical trial focuses on studying neurodegenerative diseases, which are conditions that affect the brain and nervous system, leading to a gradual decline in mental and physical abilities. The study uses a special imaging technique called tau PET to help identify early signs of these diseases. The treatment being tested is a solution for injection known as [18F]RO6958948, also referred to as RO948 (18F). This solution contains a chemical substance that helps in visualizing certain brain processes during imaging.

The purpose of the study is to explore how this imaging method can be used to detect changes in the brain that are associated with neurodegenerative diseases. Participants will receive injections of the solution and undergo imaging scans to map the presence of tau, a protein that can build up in the brain and is linked to these diseases. The study will also involve some participants receiving a placebo, which is a substance with no active treatment, to compare results.

Throughout the study, participants will have regular imaging sessions and may undergo additional tests to measure various substances in the body, such as proteins in the blood and cerebrospinal fluid. These tests help researchers understand how the disease progresses and how the treatment affects the brain. The study aims to provide valuable insights into the early detection and understanding of neurodegenerative diseases, potentially leading to better treatment options in the future.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
Upon joining the study, you will attend an initial visit where the study team will explain the trial in detail. You will be asked to sign an informed consent form, confirming your understanding and willingness to participate.
During this visit, your eligibility will be confirmed based on criteria such as age, language proficiency, and participation in specific studies. You must be at least 18 years old and able to understand Swedish without an interpreter.
Step 2
Screening and baseline assessments
You will undergo various assessments to establish baseline measurements. These may include cognitive tests, medical history review, and possibly imaging scans like MRI to assess brain structure and function.
Blood and cerebrospinal fluid (CSF) samples may be collected to measure specific proteins and markers related to neurodegenerative diseases.
Step 3
Administration of study medication
You will receive an injection of the study medication, RO948 (18F), which is a solution for injection. This medication is used to help map brain changes associated with neurodegenerative diseases.
The injection is administered to help visualize certain brain processes using imaging techniques.
Step 4
Imaging sessions
Following the administration of the study medication, you will participate in imaging sessions. These sessions use advanced imaging techniques to capture detailed images of your brain.
The primary goal is to observe the uptake of the study medication in different brain regions, which helps in understanding disease processes.
Step 5
Follow-up assessments
Throughout the trial, you will have follow-up visits to monitor your health and any changes in your condition. These visits may include additional cognitive tests and imaging scans.
Blood and CSF samples may be collected again to track changes in specific markers over time.
Step 6
End of study procedures
At the end of your participation in the study, you will undergo final assessments to gather comprehensive data on your health and any effects of the study medication.
You will have the opportunity to discuss your experience and any concerns with the study team.

Who can join the trial?

10 criteria

Signed informed consent form. This means you agree to participate after understanding the study details.
Must be 18 years or older.
Must be able to understand the study information and make an informed decision about participating.
Must be part of one of the following studies: H75, H70 Clinical Study, Epilepsy Study, BioMin Study, or SWEDOWN study.
Must speak and understand Swedish well enough to not need an interpreter.
Women who can have children must agree to use a highly effective form of birth control for 90 days after each study treatment. This includes methods like:
- Combined hormonal birth control (estrogen and progestogen) that stops ovulation.
- Progestogen-only hormonal birth control that stops ovulation.
- Intrauterine device (IUD).
- Intrauterine hormone-releasing system (IUS).
- Men with female partners who can have children must use condoms for at least 90 days after each study treatment, unless their partner is using a highly effective birth control method.

Who cannot join the trial?

3 criteria

Patients with any **neurodegenerative diseases** cannot participate. These are conditions where the brain and nerves gradually worsen over time.
Patients who are not within the specified age range for the study cannot participate.
Patients who belong to certain vulnerable groups may not be eligible to participate. This includes individuals who might need special protection or care.

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Verified sites

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Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vaestra Goetalandsregionen
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Gothenburg, Sweden

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Investigated drugs

NeuroPET GBG 001 is a new type of brain scan that helps doctors see changes in the brain that might lead to diseases like Alzheimer's. This scan looks for a protein called tau, which can build up in the brain and cause problems. By using this scan, doctors hope to find out who might get these diseases early on and understand how the disease changes over time.

2-(6-[18F]Fluoro-Pyridin-3-Yl)-9H-Dipyrido[2,3-B:3',4'-D]Pyrrole

What is already known about the treatment

NeuroPET GBG 001 – This medication is administered through a specialized imaging technique called PET (Positron Emission Tomography) to help visualize and map the presence of tau proteins in the brain. It is currently being studied in clinical trials to determine its effectiveness in identifying early signs of neurodegenerative diseases, such as Alzheimer's. The main therapeutic indication is to aid in the early detection and monitoring of these diseases by highlighting areas of tau accumulation. At the molecular level, it works by binding to tau proteins, which are associated with the progression of neurodegenerative disorders, allowing them to be seen on PET scans. This medication falls under the pharmacological classification of diagnostic agents used in neuroimaging.

Investigated diseases

Alzheimer's Disease – Alzheimer's Disease is a progressive neurodegenerative disorder characterized by the gradual decline in cognitive function, including memory, reasoning, and language skills. It typically begins with mild memory loss and confusion, which can lead to difficulties in recognizing familiar people and places. As the disease progresses, individuals may experience significant changes in personality and behavior, such as increased agitation or withdrawal. The accumulation of abnormal protein deposits, such as amyloid plaques and tau tangles, in the brain is a hallmark of the disease. Over time, these changes lead to the loss of neurons and brain tissue, affecting the ability to perform daily activities. The progression of Alzheimer's Disease varies among individuals, but it generally leads to severe cognitive impairment and dependency on others for care.