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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

Participants must be between 40 and 79 years old.
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.
- 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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	01.08.2023

Trial locations

Investigated drugs:

Izaflortaucipir (18F)

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.

Investigated diseases:

Progressive supranuclear palsy

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.

Trial ID:

2023-503538-37-00

Protocol code:

CUN-PETNeuroTau

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

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