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Efficacy and Safety of Trontinemab with [18F]MK-6240 in Cognitively Unimpaired Individuals at Risk for Alzheimer’s Disease

Fast replyInvestigationalNo placebo

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What is this trial about?

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

Alzheimer’s disease is a brain condition that gradually impairs memory and thinking. The study focuses on people who currently have normal thinking abilities but have risk factors that may lead to the development of symptoms later in life. The goal of the study is to find out whether the new medicine can delay the time it takes for symptoms to appear.

Participants receive either the experimental drug Trontinemab or a placebo through an intravenous infusion, which means the medication is delivered slowly into a vein. Throughout the trial, participants undergo regular brain scans using a special imaging test called MRI after receiving a tracer named [18F]MK-6240 to help visualize specific brain changes. In addition to the scans, they complete a series of simple memory and thinking tests and have routine health checks to monitor safety. The study lasts several years, with visits scheduled at set intervals to collect all of this information.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment and randomization
After signing consent, you are assigned to receive either trontinemab or a matching placebo in a double‑blind manner, meaning you will not know which one you receive.
Step 2
Baseline assessments
A series of tests are performed to record your current health and cognitive status, including memory tests, questionnaires, physical examination, laboratory tests, electrocardiogram, and brain imaging.
An imaging agent called [18f]mk-6240 is injected at a dose of 185 mbq by intravenous bolus to evaluate amyloid presence in the brain.
Step 3
First study drug infusion
You receive an iv infusion of the assigned study drug (trontinemab or placebo) according to the study schedule.
The specific amount of trontinemab is defined by the protocol and is delivered as a solution for injection.
Step 4
Regular follow‑up visits and additional infusions
Throughout the study, you attend scheduled visits where additional iv infusions of the study drug are given as directed by the protocol.
At each visit, the same set of cognitive and functional tests, laboratory assessments, vital‑sign checks, electrocardiogram, and safety questionnaires are repeated.
Brain imaging with [18f]mk-6240 may be repeated at predetermined times to monitor changes.
Step 5
Monitoring for safety and adverse events
At every visit, staff check for any side effects, including infusion‑related reactions, changes in laboratory values, vital signs, electrocardiogram results, and signs of inflammation or bleeding in the brain seen on magnetic resonance imaging.
A specific questionnaire called the columbia‑suicide severity rating scale is used to assess mood.
Step 6
Final assessment at week 216
After approximately 216 weeks (about four years), a final set of all previous assessments is performed to determine any changes from the start of the study.
The final data are used to evaluate the effectiveness of trontinemab compared with placebo.

Who can join the trial?

6 criteria

Be between 55 and 64 years old and have at least one close family member (parent, sibling, or child) who was diagnosed with dementia before turning 75.
Weigh no more than 150 kilograms (about 330 pounds).
Have enough vision and hearing (glasses or hearing aids are allowed) to complete the memory and thinking tests used in the study.
Show no signs of problems with thinking, memory, or daily activities; in other words, be cognitively and functionally unimpaired.
Agree to use a very reliable form of birth control (methods that have less than 1% chance of failure) for the whole study period if you are a female participant.
Agree not to give any blood or blood products for transfusion while you are in the study and for one year after the last dose of the study medication.

Who cannot join the trial?

6 criteria

Having any brain condition other than Alzheimer’s that could affect thinking, such as frontotemporal dementia (a type of dementia that changes personality and language), dementia with Lewy bodies (dementia caused by abnormal protein deposits), vascular dementia (dementia due to reduced blood flow to the brain), Parkinson disease (a movement disorder), corticobasal syndrome (a rare disorder causing movement and thinking problems), Creutzfeldt‑Jakob disease (a very rare, rapidly progressing brain disease), progressive supranuclear palsy (a disorder affecting movement and eye control), frontotemporal lobar degeneration (a group of disorders affecting the front and side of the brain), Huntington disease (a genetic disease causing movement and thinking problems), normal pressure hydrocephalus (fluid buildup in the brain that can cause walking, thinking, and bladder issues), seizure disorder (a condition that causes seizures), delirium (sudden confusion), or hypoxia (low oxygen to the brain).
Having mild cognitive impairment (MCI) (early memory problems) or any form of dementia (significant loss of memory and thinking abilities).
Having a serious brain injury that caused lasting nerve problems or visible brain damage, known as a severe, clinically significant central nervous system (CNS) trauma.
Having a serious mental health condition such as schizophrenia (a disorder with hallucinations or delusions), schizoaffective disorder (a mix of schizophrenia and mood problems), major depression (severe, persistent sadness), or bipolar disorder (extreme mood swings).
Having high blood pressure that is not under control, usually a reading above 160 mm Hg systolic (top number) or 95 mm Hg diastolic (bottom number), known as uncontrolled hypertension.
Being pregnant, breastfeeding, or planning to become pregnant during the study.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Aalborg University Hospital
Aalborg, Denmark
Verified
Barcelonabeta Brain Research Center
Barcelona, Spain
Responsive
Region Midtjylland
Aarhus, Denmark

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Investigated drugs

Trontinemab
is an experimental medicine being tested to see if it can slow the development of symptoms in people who are at risk for Alzheimer’s disease. It is given through an IV infusion, which means it is delivered directly into a vein using a needle. The drug is designed to target specific processes in the brain that are thought to contribute to Alzheimer’s, with the goal of protecting brain function and delaying disease progression.
[18F]MK-6240
is a special imaging agent used during PET scans to help doctors see the buildup of abnormal proteins called tau in the brain. It contains a tiny amount of a harmless radioactive substance that allows the scan to create detailed pictures of where tau is located. This helps researchers understand how the disease is affecting each participant and provides important information about the effectiveness of the test medication.

What is already known about the treatment

Trontinemab
Trontinemab is given as an IV infusion using a sterile solution for injection. It is an experimental monoclonal antibody that is currently in Phase III clinical trials and has not yet received market approval. The drug is being studied to slow or prevent the onset of Alzheimer’s disease in people who are still cognitively normal but at risk. It works by attaching to the tau protein in the brain and blocking its spread between nerve cells, and it belongs to the class of anti‑tau biologic therapies.
[18F]MK-6240
[18F]MK-6240 is administered as a single intravenous bolus injection of a radioactive solution for PET scanning. This radiotracer is approved only for research use and is not a therapeutic medication. It is used to image tau protein deposits in the brains of participants being evaluated for Alzheimer’s disease risk. The compound binds specifically to tau aggregates, allowing a PET camera to create pictures of where tau is located, and it is classified as a PET tau imaging agent.

Investigated diseases

Alzheimer's disease - Alzheimer’s disease is a neurodegenerative disorder characterized by the gradual buildup of abnormal protein deposits in the brain. In its earliest stage, individuals may have no noticeable symptoms despite underlying changes. Over time, these changes lead to mild memory problems and difficulty with complex tasks. As the disease advances, memory loss becomes more pronounced and everyday activities become harder to perform. Eventually, individuals experience significant cognitive and functional impairment.