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Study on Brain Changes in Alzheimer's Disease Using Flortaucipir (18F) for Patients with Alzheimer's and Its Variants

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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 Alzheimer's disease and its different forms. The study will use a special imaging technique called PET (Positron Emission Tomography) to look at the brain. A substance called 18F-AV-1451, also known as Flortaucipir (18F), will be used in this imaging process. This substance is injected into the body and helps highlight certain areas of the brain during the scan.

The purpose of the study is to understand how the brain changes in people with Alzheimer's disease. Researchers will look at how certain brain areas are affected and how these changes relate to the brain's structure and function. The study will involve taking images of the brain using MRI (Magnetic Resonance Imaging) and PET scans. These images will help researchers see where certain proteins, called tau proteins, build up in the brain. The study will also explore how these protein buildups are connected to changes in brain size and function.

Participants in the study will undergo several brain scans over a period of time. These scans will help researchers gather information about the distribution of tau proteins and how they affect brain networks. The study aims to provide a better understanding of the mechanisms behind Alzheimer's disease and its impact on the brain. This research could lead to new insights into how the disease progresses and potentially inform future treatments.

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
Joining the study
Upon joining the study, the participant will be required to provide informed consent. This involves signing a form that confirms understanding of the study's purpose and procedures.
Step 2
Initial assessment
An initial assessment will be conducted to confirm eligibility. This includes a review of medical history and specific tests to verify the presence of Alzheimer's pathology.
Tests may include the analysis of cerebrospinal fluid (CSF) to check for specific protein levels and a PET-amyloid imaging test.
Step 3
Imaging procedures
Participants will undergo various imaging procedures to study brain activity and structure. These include PET brain imaging using the solution for injection called 18F-AV-1451.
The imaging will help in understanding the distribution of tau lesions in the brain and their correlation with brain structure and function.
Step 4
Follow-up assessments
Regular follow-up assessments will be conducted to monitor changes over time. These assessments may include additional imaging and cognitive tests.
The frequency and duration of these follow-up assessments will be determined by the study protocol and communicated to the participant.
Step 5
Completion of the study
Upon completion of the study, participants will receive a summary of their individual results and any relevant findings from the study.
The estimated end date for the study is December 20, 2028.

Who can join the trial?

19 criteria

Must be affiliated with a social security insurance or be a beneficiary.
Must sign an informed consent form, or have it signed by a legal representative.
Must have in vivo proof of Alzheimer's pathology. This means there should be evidence of Alzheimer's disease from tests done on the body while the person is alive.
Specific proteins must be detected in the cerebrospinal fluid (CSF)
Aβ1-42 peptide less than 500 micrograms per milliliter (μg/ml).
tau protein greater than 450.
phosphorylated tau protein greater than 60.
IATI index less than 1.
tau/Aβ protein ratios greater than 1.23.
phosphorylated tau protein/Aβ1-42 greater than 0.211.
Or, a positive PET-amyloid imaging test, which is a type of brain scan that can show signs of Alzheimer's disease.
Must have an early-onset episodic memory deficit, meaning memory problems that start before the age of 65 and get worse over time.
Must show evidence of hippocampal amnesic syndrome during memory tests. This is a condition where the part of the brain responsible for memory (the hippocampus) is not working properly, leading to memory problems.
For the PCA group (Posterior Cortical Atrophy), patients must have a clinical and cognitive profile suggestive of PCA, characterized by:

In vivo proof of Alzheimer's pathology.
Specific impairment of neuro-visual abilities, meaning problems with processing visual information, without major memory or executive function disorders.
Two possible variants:

Occipito-temporal variant: problems with visual perception, difficulty recognizing objects, symbols, words, or faces.
Biparietal variant: problems with spatial awareness, including conditions like Gerstmann syndrome, Balint syndrome, gestural apraxia, and visual-spatial neglect.
For the control subjects group, participants must have normal neurological and neuropsychological examinations and be matched in age to patients.
Both male and female participants are eligible.
Vulnerable populations are included in the study.

Who cannot join the trial?
7 criteria

Patients who do not have a diagnosis of Alzheimer's disease.
Patients who are not within the specified age range for the study.
Patients who are not able to undergo PET brain imaging or MRI scans. PET stands for Positron Emission Tomography, a type of imaging test that helps doctors see how the organs and tissues inside your body are working. MRI stands for Magnetic Resonance Imaging, a test that uses powerful magnets and radio waves to create pictures of the body.
Patients who are unable to provide informed consent or understand the study procedures.
Patients who have other medical conditions that might interfere with the study results.
Patients who are pregnant or breastfeeding.
Patients who are participating in another clinical trial at the same time.

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Verified sites
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French Alternative Energies And Atomic Energy Commision
Orsay, France
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Hopital Beaujon
Clichy, France
Trial locations
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Investigated drugs

18F-AV-1451 is a special type of imaging agent used in brain scans to help doctors see certain changes in the brain that are linked to Alzheimer's disease. It works by attaching to tau proteins, which can build up in the brains of people with Alzheimer's. By using this agent in a PET scan, doctors can get a clearer picture of where these tau proteins are located in the brain. This helps them understand how the disease is affecting the brain and can guide them in studying how the brain might be trying to resist or adapt to these changes.

Flortaucipir (18F)

What is already known about the treatment

18F-AV-1451 – This medication is administered through an injection and is used in PET brain imaging to study Alzheimer's disease. It is currently being researched to understand its role in identifying tau protein deposits in the brain, which are associated with Alzheimer's. The main therapeutic indication is to help visualize and map the distribution of tau lesions in the brain, aiding in the diagnosis and understanding of Alzheimer's pathology. At the molecular level, 18F-AV-1451 binds to tau proteins, allowing them to be seen on PET scans. It is classified as a radiopharmaceutical used in diagnostic imaging.

Investigated diseases

Alzheimer's Disease – Alzheimer's Disease is a progressive neurological disorder characterized by the degeneration of brain cells, leading to memory loss and cognitive decline. It typically begins with mild memory lapses and confusion, which gradually worsen over time. As the disease progresses, individuals may experience difficulties with language, disorientation, mood swings, and behavioral changes. The accumulation of abnormal protein deposits, such as amyloid plaques and tau tangles, disrupts communication between brain cells. This disruption leads to the shrinking of brain regions involved in memory and reasoning. Eventually, Alzheimer's Disease affects the ability to carry out daily activities and recognize familiar people and places.