This study is looking at Alzheimer’s Disease in its early stages, which includes people with mild cognitive impairment or mild dementia caused by Alzheimer’s. Alzheimer’s Disease is a brain condition that affects memory, thinking, and the ability to perform daily activities. The study will test a medication called trontinemab, which is given through a vein, and compare it to placebo. Several imaging substances will also be used during the study, including Amyvid, Vizamyl, Neuraceq, and a substance with the code name [18F]MK-6240. These imaging substances contain radioactive materials called florbetapir, flutemetamol, florbetaben, and florquinitau that help doctors see certain proteins in the brain.
The purpose of the study is to see if trontinemab can slow down the worsening of symptoms in people with early Alzheimer’s Disease over a period of 72 weeks. During the study, people will receive either trontinemab or placebo through an infusion into a vein. The imaging substances will be given as injections to take special brain scans that show protein deposits linked to Alzheimer’s Disease. These scans help doctors understand what is happening in the brain.
Throughout the study, doctors will check how well people can think, remember things, and carry out everyday tasks using various tests and questionnaires. They will also monitor safety by checking for side effects, doing physical examinations, taking blood samples, and performing brain scans to look for any changes or problems. Some people in the study will have additional tests, including spinal fluid collection to measure certain proteins and extra brain scans to see tau protein, which is another substance that builds up in Alzheimer’s Disease. The study will measure changes in symptoms, brain protein levels, and overall safety of the treatment.
1Initial screening and confirmation
Your vision and hearing will be assessed to ensure they are adequate for completing the tests required during the study.
Your ability to perform memory and thinking tests will be evaluated. This includes a test called Mini-Mental State Examination, where your score must be 22 or higher.
Your overall cognitive function will be assessed using the Clinical Dementia Rating scale, which should show a score of 0.5 or 1.0.
A memory test called Repeatable Battery for the Assessment of Neuropsychological Status will be performed. Your delayed memory score must be 85 or lower to qualify.
Confirmation of Alzheimer’s disease pathology will be required through either a PET scan (a brain imaging test that shows amyloid protein deposits) or a cerebrospinal fluid test (a sample of fluid from around your spine).
A study partner must be available to participate with you throughout the study. This person should know you well and can provide information about your daily activities and symptoms.
2Randomization and treatment assignment
You will be randomly assigned to receive either trontinemab (the study medication) or placebo (an inactive substance that looks like the study medication but contains no active ingredient).
Neither you nor the study staff will know which treatment you are receiving. This is called a double-blind study design.
3Treatment phase
You will receive your assigned treatment through an intravenous infusion (a slow injection into a vein) or intravenous bolus injection (a quick injection into a vein).
The treatment will continue for 72 weeks (approximately 18 months).
The exact dosage and frequency of administration will be determined by the study protocol.
4Regular monitoring visits
Throughout the 72-week treatment period, you will attend regular visits for monitoring and assessments.
At these visits, your thinking abilities and memory will be tested using several assessments, including the Alzheimer’s Disease Assessment Scale-Cognition 13, which evaluates various aspects of cognitive function.
Your ability to perform daily activities will be assessed using the Alzheimer’s Disease Cooperative Study Activities of Daily Living Inventory.
Your overall cognitive and functional status will be evaluated using the integrated Alzheimer’s Disease Rating Scale.
The Mini-Mental State Examination will be repeated to track changes in your mental state.
The Clinical Dementia Rating assessment will be performed to monitor any progression in your condition.
5Safety monitoring
Blood samples will be collected regularly to check for any changes in laboratory values and to measure specific proteins in your blood, including phosphorylated tau-217 and glial fibrillar acidic protein.
Your vital signs (such as blood pressure, heart rate, and temperature) will be measured at each visit.
Physical examinations, including neurological assessments, will be performed regularly.
An electrocardiogram (a test that records the electrical activity of your heart) will be performed periodically.
You will be asked questions from the Columbia-Suicide Severity Rating Scale to monitor your mental health and safety.
Any side effects or health problems you experience will be recorded and evaluated throughout the study.
6Brain imaging assessments
Regular MRI scans (magnetic resonance imaging) will be performed to monitor for specific changes in your brain, including amyloid-related imaging abnormalities. These abnormalities can include swelling or fluid accumulation (ARIA-E) or small areas of bleeding (ARIA-H).
Amyloid PET scans will be conducted to measure the amount of amyloid protein in your brain. These scans use small amounts of radioactive tracers, including substances called florbetapir, flutemetamol, or florbetaben, which are injected into a vein.
If you are selected for a subset group, tau PET scans will be performed to measure tau protein levels in your brain using a tracer called florquinitau.
7Cerebrospinal fluid collection (subset of participants)
If you are selected for a subset group, samples of cerebrospinal fluid will be collected at certain time points.
These samples will be analyzed to measure specific biomarkers, including phosphorylated tau-181, neurogranin, and amyloid-beta 42, which help track disease progression.
8Monitoring for infusion reactions
During and after each infusion, you will be monitored for any infusion-related reactions, which are side effects that can occur during or shortly after receiving the medication through a vein.
The type, frequency, severity, and timing of any such reactions will be recorded.
9Antibody testing
Blood samples will be collected to check if your body develops anti-drug antibodies (proteins produced by your immune system in response to the study medication).
The presence and levels of these antibodies will be measured throughout the study and compared to baseline levels.
10Final assessments at week 72
At the end of the 72-week treatment period, all cognitive, functional, and safety assessments will be repeated.
Final brain imaging scans will be performed to measure changes in amyloid and tau protein levels.
Blood and possibly cerebrospinal fluid samples will be collected for final biomarker measurements.
A comprehensive evaluation of your overall health and any side effects experienced during the study will be conducted.
Who Can Join the Study?
You must be able to speak and understand the language used for the tests at the study location
You must be able to see and hear well enough to complete thinking and memory tests, as determined by the doctor
You must have proof of Alzheimer’s disease confirmed by a special brain scan called amyloid PET scan (a test that shows protein buildup in the brain) or by testing the fluid around your spinal cord called CSF
Your score on a memory test called Mini-Mental State Examination or MMSE (a test that checks thinking abilities) must be 22 or higher
Your score on a rating scale called Clinical Dementia Rating Global Score or CDR-GS (a scale that measures how severe dementia symptoms are) must be 0.5 or 1.0
Your score on a memory test called Repeatable Battery for the Assessment of Neuropsychological Status Delayed Memory Index or RBANS DMI (a test that checks how well you remember information after a delay) must be 85 or lower
You must have a study partner available, which means someone who knows you well and can attend study visits with you and answer questions about your daily activities and symptoms
Who Cannot Join the Study?
The source data does not provide specific exclusion criteria for this clinical trial
Exclusion criteria are reasons why someone cannot join a study, such as having certain other health conditions, taking specific medications, or having test results outside required ranges
Without detailed information, we cannot list the specific reasons that would prevent participation in this trial
This study is testing a medicine called trontinemab in people with early memory and thinking problems due to Alzheimer’s disease
The trial accepts both men and women as participants
Trontinemab is an investigational medication being studied for the treatment of early Alzheimer’s disease. This medicine is designed to help slow down the progression of symptoms in people who have mild cognitive impairment or mild dementia caused by Alzheimer’s disease. In this study, trontinemab is being tested to see if it can help slow the worsening of memory and thinking problems compared to a placebo.
Early Symptomatic Alzheimer’s Disease – This condition represents the initial stages of Alzheimer’s disease when symptoms first become noticeable. It includes a phase called mild cognitive impairment, where memory and thinking problems are present but do not significantly interfere with daily life. As the disease progresses to mild dementia, these cognitive difficulties become more apparent and begin to affect everyday activities. People with this condition may experience problems with memory, language, decision-making, and performing familiar tasks. The disease gradually worsens over time, with brain changes including the buildup of abnormal proteins that damage nerve cells. During this early symptomatic phase, individuals are still able to function relatively independently but may need some assistance with complex tasks.
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