Comparison of Three PET Tau Tracers ([18F]RO948, [18F]PI2620, and [18F]MK-6240) in People with Cognitive Impairment

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What is this study about?

This study focuses on comparing different imaging methods for detecting tau proteins in the brain of people with various forms of cognitive disorders. The study will use three different radioactive substances: [18F]RO6958948, [18F]PI-2620, and [18F]MK-6240, which are special tracers that can help visualize tau proteins in the brain using PET scanning. Additionally, Vizamyl will be used as a complementary imaging agent.

The research aims to understand how these different imaging tracers work in people with various cognitive conditions, including Mild Cognitive Impairment, Alzheimer’s Disease, Frontotemporal Dementia, Progressive Supranuclear Palsy, Corticobasal Degeneration, Dementia with Lewy Bodies, and Down’s Syndrome. Each participant will receive the imaging substances through an injection into a vein.

During the study, participants will undergo several brain scans. The imaging substances will be given in very small amounts and are designed to attach to tau proteins in the brain, making them visible during the scanning procedure. These scans will help researchers compare how well each tracer works in showing tau protein buildup in different brain areas over time.

1 Initial PET scan session

You will receive an intravenous injection of one of the three imaging substances: Florquinitau F-18, VIZAMYL, or PI-2620.

A PET scan (a special type of brain imaging) will be performed to create detailed pictures of your brain.

The scan will focus on measuring tau protein levels in your brain tissue.

2 Brain structure imaging

An MRI scan (detailed brain structure imaging) will be performed.

The MRI images will be used together with the PET scan results for accurate analysis.

3 Blood sample collection

Blood samples will be taken to measure specific proteins related to brain health.

The blood test will check for different forms of tau protein in your blood.

4 Follow-up visits

Multiple visits will occur between July 2024 and May 2027.

Each visit will include similar procedures to track changes over time.

The study will measure how tau protein levels change in your brain during this period.

5 Cognitive assessments

Regular memory and thinking tests will be conducted.

These tests will help track any changes in cognitive function over time.

Who Can Join the Study?

For healthy individuals without memory problems:
- Must be over 18 years old
- At least 5 young participants aged 18-28 years needed
- Must have normal cognitive function (CDR score of 0)
For individuals with Mild Cognitive Impairment (MCI):
- Age between 50-90 years
- Must meet NIA-AA 2018 diagnostic criteria
- Memory test score (MMSE) between 22-28 points
For individuals with Alzheimer’s Disease:
- Age between 50-90 years
- Must meet NIA-AA 2018 diagnostic criteria
- Memory test score (MMSE) between 11-24 points
For individuals with other conditions:
- Age between 50-90 years for:
  - Frontotemporal Dementia
  - Primary Progressive Aphasia (speech problems)
  - Progressive Supranuclear Palsy
  - Corticobasal Degeneration
  - Dementia with Lewy Bodies
For individuals with Down’s Syndrome:
- Must be over 18 years old
Both men and women can participate in the study

Who Cannot Join the Study?

History of severe allergic reactions or hypersensitivity to any PET tracer components
Presence of any metallic implants that would interfere with brain imaging (such as pacemakers, surgical clips)
Current pregnancy or breastfeeding
Inability to lie still for approximately 90 minutes during the scanning procedure
Severe claustrophobia (fear of confined spaces) that would prevent completion of the scanning
Participation in other clinical trials involving investigational drugs within 30 days prior to this study
Any medical condition that, in the investigator’s opinion, makes the person unsuitable for the study
Known severe kidney or liver dysfunction
History of significant head trauma or brain surgery
Unable to provide informed consent
Weight exceeding the scanning equipment’s maximum capacity (usually 350 pounds/160 kg)
Active substance abuse or dependence within the past year

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Hvxpdtrm Dc Lp Sklfq Cnpu I Slfg Pvo	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	01.07.2024

Trial locations

Investigated drugs:

[18F]RO948 is a specialized radioactive tracer used in PET brain imaging. It helps doctors see abnormal protein deposits called tau in the brain. This tracer allows visualization of brain changes that may be related to various neurological conditions.

[18F]PI2620 is a radioactive imaging agent used in PET scans of the brain. It binds to tau protein accumulations, helping doctors to see these deposits in living patients. This tracer is designed to provide detailed images of tau distribution in the brain.

[18F]MK-6240 is a radioactive substance used in PET brain imaging. Like the other tracers, it attaches to tau protein deposits in the brain, allowing doctors to see their location and amount. This helps in studying brain changes and potential neurological conditions.

Cognitive Impairment – A condition that affects mental abilities, including memory, learning, concentration, and decision-making. It ranges from mild to severe forms and can affect one or multiple cognitive functions. The condition may develop gradually over time, impacting daily activities and social interactions. Cognitive impairment can affect people’s ability to process information, understand complex tasks, or remember important details. While some individuals experience stable symptoms, others may notice progressive changes in their cognitive abilities over time.

Trial ID:

2023-510508-31-01

Protocol code:

IIBSP-HEA-2022-145

Trial Phase:

Therapeutic exploratory (Phase II)

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Comparison of Three PET Tau Tracers ([18F]RO948, [18F]PI2620, and [18F]MK-6240) in People with Cognitive Impairment

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?