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Study of flortaucipir and florbetapir in patients with memory disorders including Alzheimer's disease and dementia

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study examines several different conditions that affect memory and thinking abilities. These conditions include Alzheimer's disease, Lewy Body Dementia, a language disorder called Semantic Variant Primary Progressive Aphasia, memory problems related to Alcohol Use Disorder, memory loss conditions grouped as organic amnesia syndrome, and Narcolepsy which is a sleep disorder. The study will use two imaging substances called flortaucipir (18F) and florbetapir (18F) which are given through injection into a vein. These substances help doctors see certain changes in the brain using special scanning equipment.

The purpose of this study is to examine how memory-related brain networks are preserved or damaged in different groups of patients with memory disorders from various causes, and to understand the different types of memory strategies that memory experts use. The study will also include healthy people, professional theater actors, and memory athletes who compete in memory competitions. By comparing these different groups, researchers want to learn more about how the brain supports memory and what happens when memory becomes impaired.

Participants will undergo several days of testing and examinations. These will include brain scans using different techniques, memory and thinking tests, questionnaires about daily life and sleep, sleep monitoring, blood tests, and physical measurements. Some participants will receive the imaging substances to allow detailed pictures of their brain to be taken. The study will measure the size of different brain areas, how blood flows through the brain, and the presence of certain proteins that are associated with memory disorders. The information gathered will help researchers understand the brain structures and networks that support memory function in both healthy individuals and those with various memory problems.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessments and baseline evaluations
After joining the study, you will undergo several days of assessments as part of the evaluation process.
You will complete various questionnaires to collect information about your lifestyle, sleep patterns, and psychological well-being.
You will participate in neuropsychological tests to evaluate different aspects of your memory and cognitive function. These tests measure how well you remember, learn, and process information.
You will complete a directed forgetting task, which involves identifying words you were asked to remember or forget.
A medical interview will be conducted to collect your health information and physical measurements such as height and weight.
An electrocardiogram will be performed to record the electrical activity of your heart.
If applicable to your group, a Fibroscan may be performed to measure liver fibrosis. This is a non-invasive test that uses sound waves to assess liver health.
A blood sample will be collected for laboratory analysis.
Step 2
Sleep monitoring and assessment
You will complete sleep questionnaires to provide information about your sleep quality and patterns.
You will wear an actigraphy device, which is a small watch-like monitor that tracks your movement and sleep-wake patterns over a period of time.
You will undergo polysomnographic recording, which is an overnight sleep study that monitors your brain waves, breathing, heart rate, and other body functions while you sleep.
A SomnoArt device will be used to collect additional sleep-related data.
Step 3
Brain imaging with magnetic resonance imaging
You will undergo magnetic resonance imaging, also known as MRI, which uses magnetic fields and radio waves to create detailed images of your brain.
The MRI will measure the volume of gray matter in different areas of your brain, including the hippocampus (a region important for memory) and the thalamus.
The scan will also assess the white matter of your brain, looking at its structure and any areas of damage.
A special type of MRI called functional MRI will measure brain activity while you perform memory tasks, such as learning and recalling text.
During the functional MRI, you will complete tasks involving reading, verbal articulation, encoding information, and recalling what you have learned.
Step 4
Brain imaging with positron emission tomography using florbetapir
You will receive an intravenous injection of a radiopharmaceutical called florbetapir (18F), also known as Amyvid.
This substance is injected into a vein and travels to your brain, where it binds to beta-amyloid protein deposits. Beta-amyloid is a protein that can accumulate in the brains of people with certain memory disorders.
After the injection, you will undergo a positron emission tomography scan, also known as PET scan, which creates images showing the distribution of the radiopharmaceutical in your brain.
The early-phase images from this scan will also provide information about blood flow in different brain regions.
The scan will measure the amount of beta-amyloid burden throughout your brain.
Step 5
Brain imaging with positron emission tomography using flortaucipir
You will receive an intravenous injection of a radiopharmaceutical called flortaucipir (18F), also known as Tauvid.
This substance is injected into a vein and travels to your brain, where it binds to abnormal tau protein. Tau protein can form tangles in the brain that are associated with certain memory disorders.
After the injection, you will undergo a positron emission tomography scan, which creates images showing where the tau protein is located in your brain.
The scan will measure the burden of neurofibrillary tangles and abnormally phosphorylized tau protein, particularly in the temporal region of your brain.
Step 6
Brain electrical activity monitoring
You will undergo electroencephalography, also known as EEG, which records the electrical activity of your brain using sensors placed on your scalp.
During the EEG, you will listen passively to auditory stimuli (sounds) while the device records your brain's responses.
The EEG will also record your brain's spontaneous oscillatory activity while you are in a resting state, meaning you are awake but not performing any specific task.
This assessment measures how different areas of your brain communicate with each other through functional brain connectivity.
Step 7
Informant assessment
If applicable, a person who knows you well and spends time with you regularly may be asked to complete questionnaires about you.
This person, called an informant, will provide information about your daily functioning and any changes they have observed.
The informant will also provide basic information about their relationship with you, including how often you meet and how long you have known each other.

Who can join the trial?

42 criteria

All participants must have completed at least 7 years of education
All participants must be native French speakers and educated in French
All participants must be affiliated with a French social security scheme or be a beneficiary of such a scheme
All participants must be willing to undergo several days of assessments
All participants must follow certain lifestyle considerations
All participants must sign an informed consent form to participate in the study
Healthy participants must be 18 years of age or older
Healthy participants must have brain function test results that are normal for their age and education level on all screening tests
Healthy participants must be considered able to follow the study procedures according to the doctor's judgment
Memory athletes must be 18 years of age or older
Memory athletes must have participated in a memory competition at international, European, or national level
Memory athletes must be considered able to follow the study procedures according to the doctor's judgment
Participants with subjective cognitive decline, which means they feel their memory is declining but tests do not show major problems, must be 60 years of age or older
Participants with subjective cognitive decline must be recruited from memory clinics, which are specialized centers that evaluate memory problems
Participants with subjective cognitive decline must meet recognized medical criteria for subjective cognitive decline in the context of the early stage of Alzheimer's disease
Participants with mild cognitive impairment due to Alzheimer's disease, which means they have noticeable memory problems but can still manage daily activities, must be 60 years of age or older
Participants with mild cognitive impairment due to Alzheimer's disease must be recruited from memory clinics
Participants with mild cognitive impairment due to Alzheimer's disease must meet current recognized medical criteria for this condition
Participants with dementia due to Alzheimer's disease, which means they have significant memory and thinking problems that affect daily life, must be 60 years of age or older
Participants with dementia due to Alzheimer's disease must be recruited from memory clinics
Participants with dementia due to Alzheimer's disease must meet current and recognized medical criteria for major neurocognitive disorder, which is a severe decline in thinking abilities, due to probable Alzheimer's disease
Participants with Lewy body dementia, which is a type of dementia that affects thinking, movement, and behavior, must be 60 years of age or older
Participants with Lewy body dementia must be recruited from memory clinics
Participants with Lewy body dementia must meet current and recognized medical criteria for probable Lewy body dementia or its early stage
Participants with semantic variant primary progressive aphasia, which is a condition that affects language and the ability to understand word meanings, must be 50 years of age or older
Participants with semantic variant primary progressive aphasia must be recruited from memory clinics
Participants with semantic variant primary progressive aphasia must meet current and recognized medical criteria for semantic dementia
Participants with alcohol use disorder must be 18 years of age or older
Participants with alcohol use disorder must be recruited from an addiction treatment service
Participants with alcohol use disorder must be undergoing treatment primarily for an alcohol use disorder at the time of joining the study
Participants with alcohol use disorder must be detoxified, which means their body has cleared the alcohol, with withdrawal symptoms resolved and certain medications stopped at the time of joining the study
Participants with alcohol use disorder must be abstinent from all substances that affect the mind, except tobacco and prescribed medication, at the time of joining the study
Participants with organic amnesia syndrome, which is severe memory loss caused by physical damage to the brain, must be 18 years of age or older
Participants with organic amnesia syndrome must be recruited from hospital services or residential facilities
Participants with organic amnesia syndrome must have major cognitive impairment mainly characterized by severe memory deficits that significantly impact daily functioning and independence, and are persistent and stable over time
Participants with narcolepsy, which is a sleep disorder causing excessive daytime sleepiness and sudden sleep attacks, must be 18 years of age or older
Participants with narcolepsy must be diagnosed with type 1 narcolepsy according to recognized international criteria, which includes daytime sleepiness lasting more than 3 months and either sudden muscle weakness triggered by emotions or very low levels of a specific brain chemical
Informants, who are people providing information about a participant, must be 18 years of age or older
Informants must spend at least one day per week with a relative included in one of the patient groups
Actors must be 18 years of age or older
Actors must have performed in at least one theatre play in the last three years
Actors must be or have been a professional actor for at least 5 years

Who cannot join the trial?

7 criteria

The study does not list specific reasons why patients cannot participate
However, general safety considerations typically apply to all clinical trials
Patients should discuss their complete medical history with the research team to determine if participation is appropriate
Certain medications or other medical conditions not listed in the study description may affect eligibility
Pregnancy or plans to become pregnant may be a consideration for female participants
Inability to undergo brain imaging (pictures of the brain using special machines) may prevent participation
Severe medical conditions that could make study procedures unsafe may exclude participation

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Centre Hospitalier Universitaire De Caen Normandie
Caen, France

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Investigated drugs

Amyvid
is a radioactive imaging agent used during a special brain scan called a PET scan. It helps doctors see and measure the amount of amyloid plaques in the brain. Amyloid plaques are abnormal protein deposits that can build up in the brain and are associated with memory problems and certain brain conditions.
Tauvid
is a radioactive imaging agent used during a PET scan to help doctors visualize tau protein tangles in the brain. Tau tangles are abnormal structures that form inside brain cells and are linked to memory decline and certain brain disorders. This medication allows doctors to see where these tangles are located and how much of them are present in the brain.

What is already known about the treatment

Amyvid
Amyvid is an injectable imaging agent used during brain scans to detect beta-amyloid plaques, which are abnormal protein deposits associated with Alzheimer's disease and other memory disorders. It is administered intravenously and works by binding to amyloid plaques in the brain, making them visible on PET (positron emission tomography) scans. This radiopharmaceutical belongs to the class of diagnostic imaging agents and is approved for clinical use to help physicians evaluate patients with cognitive decline. The scan results, combined with other medical information, assist doctors in determining whether memory problems may be related to Alzheimer's disease or other neurological conditions.
Tauvid
Tauvid is an injectable diagnostic imaging drug used to visualize tau protein tangles in the brain through PET scanning, which helps in assessing patients with cognitive impairment. It is given intravenously and works by attaching to abnormal tau proteins that form tangles inside brain cells, a hallmark feature of Alzheimer's disease and certain other brain disorders affecting memory. As a radiopharmaceutical diagnostic agent, Tauvid is approved for medical use and provides doctors with important information about the distribution and density of tau tangles in a patient's brain. This imaging tool helps healthcare providers better understand the nature of memory problems and supports more accurate diagnosis of neurodegenerative diseases.

Investigated diseases

Semantic Variant Primary Progressive Aphasia
This is a progressive brain disorder that primarily affects language abilities. It begins with difficulties in understanding and using words, particularly in naming objects and finding the right words during conversation. Over time, the person loses knowledge of word meanings, which makes it increasingly hard to communicate. The condition gradually worsens, affecting the ability to read and write as well. Memory for recent events and daily activities typically remains relatively preserved in the early stages. The disease is caused by the gradual deterioration of specific areas in the brain responsible for language processing.
Alcohol Use Disorder
This is a medical condition characterized by an inability to control or stop alcohol consumption despite negative consequences. The disorder develops when repeated alcohol use causes significant problems in daily life, relationships, work, or health. People with this condition often experience strong cravings for alcohol and may need to drink more to achieve the same effects. When they try to reduce or stop drinking, they may experience withdrawal symptoms such as anxiety, tremors, or sweating. The pattern of drinking becomes increasingly difficult to manage over time. The disorder can range from mild to severe depending on the number of symptoms present.
Organic Amnesia Syndrome
This condition involves significant memory impairment caused by physical damage or disease affecting the brain. People with this syndrome have difficulty forming new memories and may also struggle to recall past events. The memory problems are severe enough to interfere with daily functioning and social activities. The condition can result from various causes including brain injury, stroke, infections, or lack of oxygen to the brain. Unlike normal forgetfulness, the memory loss is persistent and does not improve with reminders or cues. Other mental abilities such as language and reasoning may remain relatively intact.
Narcolepsy
This is a chronic sleep disorder characterized by overwhelming daytime drowsiness and sudden attacks of sleep. People with narcolepsy find it difficult to stay awake for extended periods regardless of the circumstances. The condition often includes sudden loss of muscle tone triggered by strong emotions, which is called cataplexy. Sleep paralysis and vivid dream-like experiences when falling asleep or waking up are also common. Nighttime sleep is often disrupted with frequent awakenings. The symptoms typically begin in adolescence or young adulthood and persist throughout life.
Alzheimer Disease
This is a progressive brain disorder that gradually destroys memory and thinking skills. It typically begins with mild memory loss, particularly difficulty remembering recent events or conversations. As the disease advances, individuals experience increasing confusion, disorientation, and difficulty with language and problem-solving. Changes in mood and behavior become more pronounced, and the person may have trouble recognizing family members and familiar places. Daily activities become increasingly challenging, eventually requiring full-time assistance. The disease is caused by abnormal protein deposits in the brain that damage and kill brain cells over time.
Lewy Body Dementia
This is a progressive brain disease caused by abnormal protein deposits called Lewy bodies that develop inside brain cells. The condition causes problems with thinking, movement, behavior, and mood. People with this disease experience fluctuating cognition, with alertness and attention varying significantly from day to day or even hour to hour. Visual hallucinations, particularly seeing things that are not present, are common and occur early in the disease. Movement problems similar to those seen in Parkinson disease, such as slowness, stiffness, and tremor, often develop. Sleep disturbances, including acting out dreams during sleep, are frequent features of the condition.