Not recruiting

Study of Remternetug for Patients with Early Alzheimer's Disease at Risk for Cognitive and Functional Decline

Verified siteInvestigational

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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, a condition that affects memory and thinking skills. The study will test a treatment called Remternetug, which is given as a solution for injection. Remternetug is also known by its code name LY3372993. The trial will compare the effects of Remternetug with a placebo to see if it can help slow down the progression of Alzheimer's Disease in people who are at risk of experiencing a decline in their cognitive and functional abilities.

The purpose of the study is to determine how long it takes for participants to experience a meaningful progression in their condition, as measured by a tool called the Clinical Dementia Rate (CDR). This tool helps assess the stage and level of impairment in individuals with early Alzheimer's Disease. Participants in the study will receive either Remternetug or a placebo and will be monitored over time to see how their condition changes.

The study is designed for individuals between the ages of 55 and 80 who have a reliable study partner and show signs of brain plaques through a screening blood test. Participants should have no or only mild problems with memory and function. The trial aims to provide valuable insights into the effectiveness of Remternetug in managing early Alzheimer's Disease and potentially slowing down its progression.

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
Initial screening
The initial screening involves a blood test to check for the presence of plaques in the brain. This is a key indicator for early Alzheimer's disease.
Participants must be between 55 to 80 years old and have a reliable study partner. Memory and function should be either normal or only mildly impaired.
Step 2
Baseline assessment
A baseline assessment is conducted to evaluate the current stage and degree of impairment using the Clinical Dementia Rating (CDR) scale. This scale helps in understanding the participant's condition at the start of the trial.
Step 3
Treatment administration
Participants receive either Remternetug or a placebo. Both are administered as a solution for injection.
The frequency and dosage of the injections are determined by the study protocol and are administered under medical supervision.
Step 4
Regular monitoring
Regular monitoring is conducted to track the participant's response to the treatment. This includes periodic assessments using the CDR scale to measure any changes in cognitive and functional abilities.
Step 5
Final assessment
At the end of the trial, a final assessment is performed to evaluate the overall progression of the disease and the effectiveness of the treatment.

Who can join the trial?

4 criteria

Be between 55 and 80 years old.
Have a reliable study partner. This means someone who can help and support you during the study.
Have a screening biomarker blood test result that indicates the presence of **plaques** in the brain. **Plaques** are unusual clumps of protein that can build up in the brain.
Have no or only mild problems with memory and function. This means you may have some memory issues, but they should not be severe.

Who cannot join the trial?

3 criteria

Patients who do not have a diagnosis of Alzheimer's Disease cannot participate. Alzheimer's Disease is a condition that affects the brain and causes memory loss and confusion.
Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for the study.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups of people who may need special protection or care.

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Verified sites

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

Verified
Barcelonabeta Brain Research Center
Barcelona, Spain
Verified
Hospital Clinic De Barcelona
Barcelona, Spain
Verified
Hospital Universitario Quironsalud Madrid
Pozuelo De Alarcon, Spain

Trial locations

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Investigated drugs

Remternetug is a medication being studied for its potential to slow down or prevent cognitive and functional decline in people with early Alzheimer's disease. It is being compared to a placebo to see if it can effectively delay the progression of symptoms associated with Alzheimer's.

LY3372993

What is already known about the treatment

Remternetug – Remternetug is administered intravenously, meaning it is given directly into a vein. It is currently being studied in clinical trials for its potential use in treating early Alzheimer's Disease, particularly in individuals at risk for cognitive and functional decline. The medication works by targeting and reducing amyloid-beta plaques in the brain, which are believed to contribute to the progression of Alzheimer's Disease. Remternetug is classified as a monoclonal antibody, a type of protein designed to bind to specific substances in the body.

Investigated diseases

Alzheimer's Disease – Alzheimer's Disease is a progressive neurological disorder that leads to the degeneration of brain cells, causing 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. In advanced stages, individuals may lose the ability to carry out daily activities and require full-time care. The progression of Alzheimer's Disease varies among individuals, but it generally follows a slow and steady decline.