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Study on Brain Imaging with [18F]PI-2620 for Progressive Supranuclear Palsy Patients

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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 a brain condition known as Progressive Supranuclear Palsy (PSP). PSP is a rare brain disorder that affects movement, control of walking, balance, speech, swallowing, vision, mood, and behavior. The study will use a special imaging technique called PET scan to look at the brain. A substance called [18F]PI-2620 will be used in the PET scan. This substance helps to highlight certain proteins in the brain that are linked to PSP.

The purpose of the study is to compare the amount of a specific protein, called tau 4R, in the brains of people with PSP to those without any neurodegenerative conditions. Participants will receive an injection of the [18F]PI-2620 solution, which will help doctors see the tau 4R protein deposits in the brain during the PET scan. The study will also look at how the brain uses sugar, which is important for understanding brain activity, and will assess symptoms related to movement and mood.

Participants in the study will include people diagnosed with PSP and a control group of individuals without neurodegenerative diseases. The study will help researchers understand more about PSP and how it affects the brain, potentially leading to better ways to diagnose and treat this condition in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
Upon joining the clinical trial, an initial visit is scheduled. During this visit, eligibility is confirmed based on age and medical condition. Consent to participate is required.
A clinical diagnosis of progressive supranuclear palsy (PSP) or being part of the control group is necessary. The control group includes individuals with Parkinson's disease or healthy subjects with normal cognitive status.
Step 2
Preparation for imaging
Preparation for the imaging study involves understanding the procedure and what to expect during the PET-Tau imaging study.
The purpose of the imaging is to assess the brain deposit of tau 4R protein using the 18F-PI2620 radiotracer.
Step 3
Imaging procedure
The imaging procedure involves receiving an injection of the 18F-PI2620 solution. This is administered as an intravenous slow bolus injection.
The imaging study is conducted to visualize the brain and assess the presence of tau protein deposits.
Step 4
Follow-up assessments
Follow-up assessments may include evaluating patterns of glucose metabolism and monitoring motor and non-motor symptoms.
These assessments help in understanding the progression of symptoms and the impact of the tau protein deposits.
Step 5
Completion of trial
The trial is expected to continue until December 2026. Participation involves periodic assessments and imaging studies as outlined in the trial protocol.
The primary goal is to compare the brain deposit of tau protein in patients with PSP to those without neurodegenerative tauopathy.

Who can join the trial?

6 criteria

Participants must be between 40 and 79 years old.
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Participants must belong to one of the following groups:
- Patients with Progressive Supranuclear Palsy (PSP): Must have a clinical diagnosis of PSP based on specific criteria.
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  Control Group:
  - Patients with Parkinson's Disease (PD): Must have a clinical diagnosis of PD and normal cognitive status, which means they score above 24 on a test called MoCA.
  - Healthy individuals: Must have a normal neurological examination and normal cognitive status, also scoring above 24 on the MoCA test.
  - The participant, or their representative, must have given consent to join the study.
  - The participant must be able, in the opinion of the study doctor, to meet all the requirements of the clinical trial.

Who cannot join the trial?

7 criteria

Patients who have any other serious medical condition that might interfere with the study.
Patients who are unable to undergo a PET-Tau imaging study. This is a special type of scan that helps doctors see certain proteins in the brain.
Patients who are currently participating in another clinical trial.
Patients who have a history of severe allergic reactions to any of the substances used in the study.
Patients who are pregnant or breastfeeding.
Patients who have a history of drug or alcohol abuse within the past year.
Patients who have any condition that, in the opinion of the study doctor, makes them unsuitable for the study.

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Hospital Universitario De Navarra
Pamplona, Spain

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Investigated drugs

18F-PI2620 is a special substance used in a type of brain scan called a PET scan. This substance helps doctors see certain proteins in the brain that are linked to a condition called Progressive Supranuclear Palsy (PSP). By using this substance, doctors can compare the amount of these proteins in people with PSP to those without this condition. This helps in understanding how the disease affects the brain and can assist in diagnosing and monitoring the condition.

Izaflortaucipir (18F)

What is already known about the treatment

18F-PI2620 – This medication is administered as an injection and is used in a PET scan, a type of imaging test. It is currently being studied in clinical trials to understand its effectiveness in detecting tau protein deposits in the brain, specifically in people with progressive supranuclear palsy (PSP). The main therapeutic indication is to help visualize and measure the amount of tau protein, which is associated with certain neurodegenerative diseases. At the molecular level, 18F-PI2620 binds to the tau protein, allowing it to be seen on the PET scan. It is classified as a radiotracer, a type of substance used in medical imaging to highlight specific areas of the body.

Investigated diseases

Progressive supranuclear palsy – Progressive supranuclear palsy is a rare brain disorder that affects movement, control of walking, balance, speech, swallowing, vision, mood, and behavior. It is characterized by the accumulation of tau protein in the brain, leading to the deterioration of certain brain cells. The disease typically begins with problems in balance and walking, often resulting in unexplained falls. As it progresses, individuals may experience stiffness, slow movements, and difficulty with eye movements, particularly looking up or down. Speech and swallowing difficulties can also develop, along with changes in mood and cognitive abilities. Over time, these symptoms can become more pronounced, affecting daily activities and quality of life.