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Study on Donanemab Dosing for Adults with Early Alzheimer's Disease

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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 the effects of different dosing regimens of Donanemab (also known by its code name LY3002813) in adults with early symptomatic Alzheimer's Disease. Alzheimer's Disease is a condition that affects the brain, leading to memory loss and other cognitive difficulties. The study aims to understand how varying doses of Donanemab impact the occurrence of a specific brain change known as ARIA-E, which stands for Amyloid-Related Imaging Abnormality-Edema/Effusion. This change can sometimes be seen in brain scans of people receiving certain treatments for Alzheimer's Disease.

Participants in the study will receive either Donanemab or a placebo, which is a substance with no active medication. The study will also use a solution called Neuraceq, which contains Florbetaben (18F), a substance used in brain imaging to help visualize certain changes in the brain. Additionally, Sodium Chloride, commonly known as salt water, will be used as a standard solution for infusion. The study will explore how these treatments affect the brain over a period of time, with regular monitoring through brain scans and other assessments.

The purpose of this study is to gather information on the safety and effectiveness of different dosing strategies of Donanemab in reducing amyloid plaques, which are protein deposits in the brain associated with Alzheimer's Disease. By comparing these strategies, researchers hope to find the most effective way to manage the disease and improve the quality of life for those affected. Participants will be closely monitored throughout the study to ensure their safety and to collect valuable data on the treatment's impact.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, you will undergo an initial assessment to confirm eligibility. This includes a review of your medical history and a series of tests to evaluate your memory function.

    You will need to have a PET scan, which is a type of imaging test that helps to visualize certain brain activities. This scan will use a substance called florbetaben (18f) to help identify specific brain changes.

  2. Step 2

    Baseline visit

    During the baseline visit, you will receive a detailed explanation of the study procedures and what to expect throughout the trial.

    You will be administered a solution for injection containing donanemab through an intravenous infusion. This is a method where the medication is delivered directly into your bloodstream.

  3. Step 3

    Treatment phase

    In the treatment phase, you will receive regular doses of donanemab. The frequency and dosage will vary depending on the specific regimen assigned to you.

    You will continue to receive these treatments over a period specified by the study, which may last several months.

  4. Step 4

    Monitoring and follow-up

    Throughout the trial, you will have regular follow-up visits to monitor your health and the effects of the treatment. This includes additional PET scans and other assessments as needed.

    The study team will closely observe any changes in your condition, particularly focusing on any occurrence of amyloid-related imaging abnormality-edema/effusion (ARIA-E).

  5. Step 5

    End of study visit

    At the end of the study, you will have a final visit to assess your overall health and gather any remaining data needed for the study.

    You will receive information about the results of the study and any next steps regarding your treatment or care.

Who can join the trial?

5 criteria

  • Participants must have a gradual and progressive change in memory function reported by themselves or someone who knows them well for at least 6 months.
  • Participants must meet the criteria for a 18F flortaucipir PET scan (a type of brain scan) as determined by a central review. This does not apply to participants in the safety group.
  • Participants must meet the criteria for a 18F florbetapir PET scan (another type of brain scan) as determined by a central review.
  • Participants can be of any gender.
  • The study includes individuals who may be considered part of a vulnerable population.

Who cannot join the trial?

10 criteria

  • Patients with any other serious medical condition that might interfere with the study.
  • Patients who have had a recent major surgery or are planning to have surgery during the study period.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a history of severe allergic reactions to medications.
  • Patients who are pregnant or breastfeeding.
  • Patients with a history of drug or alcohol abuse.
  • Patients who have been diagnosed with a different type of **dementia** other than **Alzheimer's Disease**.
  • Patients with uncontrolled high blood pressure.
  • Patients with severe liver or kidney disease.
  • Patients who have had a stroke or heart attack in the past six months.
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Investigated drugs

Donanemab is a medication being studied for its potential to help people with early symptoms of Alzheimer's disease. It works by targeting and removing a protein called amyloid that builds up in the brains of people with Alzheimer's. This buildup is thought to contribute to the symptoms of the disease. The trial is looking at different ways of giving this medication to see which method is most effective at reducing the buildup of amyloid and minimizing side effects, particularly a condition known as ARIA-E, which can cause swelling in the brain.

What is already known about the treatment

Donanemab – Donanemab is administered through an intravenous infusion, meaning it is delivered directly into the bloodstream via a vein. It is currently being studied in clinical trials for its potential to treat early symptomatic Alzheimer's Disease, a condition that affects memory and cognitive function. The medication works by targeting and removing amyloid plaques, which are abnormal protein deposits in the brain associated with Alzheimer's. Donanemab is classified as a monoclonal antibody, a type of drug designed to bind to specific proteins in the body.

Investigated diseases

  • Neurocognitive Disorders

    These are a group of disorders characterized by a decline in cognitive function, which can affect memory, attention, learning, language, and decision-making. The progression often involves a gradual worsening of cognitive abilities, impacting daily activities and independence. Symptoms may start subtly and become more noticeable over time, leading to significant impairment in social and occupational functioning.

  • Central Nervous System Diseases

    These diseases affect the brain and spinal cord, leading to a variety of symptoms depending on the specific condition. Progression can vary widely, with some diseases causing gradual deterioration of neurological function, while others may have sudden onset. Symptoms can include motor dysfunction, sensory disturbances, and cognitive impairments.

  • Neurodegenerative Diseases

    These are characterized by the progressive degeneration of nerve cells, leading to a decline in motor and cognitive functions. The progression is typically slow and irreversible, with symptoms worsening over time. Common features include memory loss, movement disorders, and changes in behavior and personality.

  • Nervous System Diseases

    These encompass a wide range of conditions affecting the nervous system, including the brain, spinal cord, and peripheral nerves. Progression can be acute or chronic, with symptoms such as pain, weakness, numbness, and cognitive changes. The impact on daily life can vary from mild to severe, depending on the specific disease.

  • Dementia

    This is a syndrome characterized by a decline in cognitive function beyond what might be expected from normal aging. It progresses gradually, affecting memory, thinking, orientation, comprehension, calculation, learning capacity, language, and judgment. As it advances, it can lead to a loss of ability to perform everyday activities.

  • Alzheimer’s Disease

    A type of dementia that involves the progressive loss of memory and other cognitive functions. It typically begins with mild memory loss and confusion, eventually leading to severe cognitive and functional impairments. The disease progresses over several years, affecting language, reasoning, and the ability to perform simple tasks.

Trial detailsLast updated 7 Oct 2026
Age65+ yearsPhasePhase IIITrial ID2022-502268-18-00Protocol codeI5T-MC-AACQEstimated enrolment800 patientsSponsorEli Lilly & Co.

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