Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

A Study of Donanemab in People With Early Symptomatic Alzheimer's Disease

Verified siteFast replyRegistered drug
Clinical Trials Concierge

Prefer not to search on your own, or looking for clinical trials for a rare disease?

What is this trial about?

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

This study is looking at Alzheimer's disease in people who are in the early stages of the condition. Alzheimer's disease is a brain disorder that gradually affects memory, thinking, and the ability to carry out daily activities. The study will test a medication called donanemab (also known by its code name LY3002813), which is an antibody designed to target a protein called amyloid beta that builds up in the brains of people with Alzheimer's disease. Some participants will receive donanemab while others will receive placebo. The study will also use special imaging substances called florbetapir (code name LY3078786) and flortaucipir (code name LY3191748) that help doctors see protein deposits in the brain through scanning procedures. Sodium chloride will be used as part of the treatment process.

The purpose of this study is to see whether donanemab can slow down the worsening of symptoms compared to placebo in people with early symptomatic Alzheimer's disease. The study will measure changes in memory, thinking abilities, and daily functioning over time to determine if the treatment is effective.

During the study, participants will receive the study medication through an infusion into a vein. The treatment will continue for a period of time while doctors monitor how well participants are doing with their memory and daily activities. Participants will need to have a study partner who knows them well and can provide information about any changes in their condition. The study will use brain scans to check for the presence of certain proteins that are associated with Alzheimer's disease. These scans help doctors understand the extent of the disease and monitor any changes during the study.

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 screening and assessment

    Your memory function will be assessed to confirm gradual and progressive changes over at least 6 months.

    You will complete a Mini-Mental State Examination, which is a questionnaire that evaluates memory and thinking abilities. Your score must be between 20 and 28 points.

    You will undergo an amyloid scan, which is a brain imaging test that detects amyloid protein deposits associated with Alzheimer's disease. This scan will determine if you meet the criteria for participation.

    A study partner must be identified who will participate alongside you throughout the trial and provide consent.

  2. Step 2

    Treatment phase with study medication

    You will receive either donanemab or placebo through intravenous infusion. A placebo is an inactive substance that looks like the real medication but contains no active treatment.

    The infusion will be administered directly into a vein over a period of time.

    The treatment phase will continue for 76 weeks.

    The specific dosage and frequency of infusions will be determined by the study protocol.

  3. Step 3

    Brain imaging assessments

    You will undergo florbetapir scans, which are imaging tests that use a radioactive tracer called florbetapir (18F) administered through intravenous infusion to visualize amyloid protein in the brain.

    You will also undergo flortaucipir scans, which use a radioactive tracer called flortaucipir (18F) administered through intravenous infusion to detect tau protein deposits in the brain.

    These imaging procedures will be performed at specific timepoints during the study to monitor changes in the brain.

  4. Step 4

    Regular clinical assessments

    Throughout the 76-week treatment period, your cognitive function and daily activities will be assessed using the Integrated Alzheimer's Disease Rating Scale.

    This scale measures both thinking abilities and the capacity to perform everyday tasks.

    Changes from your initial assessment at the start of the study will be measured at week 76.

  5. Step 5

    Safety monitoring

    Your health and any side effects will be monitored regularly throughout the study.

    Additional assessments may be performed as needed to ensure your safety during the trial.

Who can join the trial?

4 criteria

  • You must have a gradual and progressive change in memory function, which means your memory has been slowly getting worse over time. This change must have been noticed by you or someone close to you for at least 6 months.
  • You must have an MMSE score between 20 and 28 at the screening visit. MMSE stands for Mini-Mental State Examination, which is a simple test that checks your memory and thinking abilities.
  • You must meet the requirements for an amyloid scan. This is a special brain imaging test that looks for a protein called amyloid in your brain, which is associated with Alzheimer's disease.
  • You must have a study partner who agrees to participate in the study with you. This person should know you well and be willing to provide information about you. They must also sign a consent form to participate.

Who cannot join the trial?

4 criteria

  • The study information does not list specific reasons why patients cannot participate in this trial
  • If you are interested in participating, a doctor will need to review your complete medical history to determine if you meet the requirements
  • Generally, clinical trials have rules about who can join, but the specific exclusion criteria (reasons why someone cannot participate) are not provided in the available information
  • Your doctor will check if you have any health conditions or take any medications that might prevent you from safely joining this study
Clinical Trials Concierge

Prefer not to search on your own, or looking for clinical trials for a rare disease?

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Donanemab

    is an investigational medication being studied for the treatment of early symptomatic Alzheimer's disease. This medicine is designed to target and remove certain protein deposits in the brain that are associated with Alzheimer's disease. The purpose of this study is to see if donanemab can slow down the progression of symptoms in people with early-stage Alzheimer's disease compared to a placebo.

  • Placebo

    is an inactive substance that looks like the real medication but contains no active treatment. It is used in this study to compare the effects of donanemab and help determine if the medication is truly effective.

What is already known about the treatment

Donanemab – Donanemab is an investigational medication currently being studied in clinical trials for the treatment of early symptomatic Alzheimer's disease, a progressive brain disorder that affects memory, thinking, and behavior. It is administered through intravenous infusion, meaning it is given directly into a vein by a healthcare professional. This medication works at the molecular level by targeting and helping to remove abnormal protein deposits called amyloid plaques that build up in the brains of people with Alzheimer's disease, which are believed to contribute to the damage and death of brain cells. Donanemab belongs to a class of drugs known as monoclonal antibodies, which are laboratory-made proteins designed to recognize and attach to specific targets in the body.

Investigated diseases

  • Alzheimer Disease

    Alzheimer disease is a progressive brain disorder that gradually destroys memory and thinking skills. The disease begins with mild memory loss and confusion, particularly affecting recent memories and the ability to learn new information. As the condition advances, individuals experience increasing difficulty with language, problem-solving, and performing familiar tasks. Over time, personality changes and behavioral problems may develop, including anxiety, aggression, and wandering. The disease progresses through stages, from mild cognitive impairment to severe dementia where individuals lose the ability to communicate and require full-time care. Brain cells deteriorate and die, causing significant shrinkage of brain tissue.

  • Dementia

    Dementia is a general term describing a decline in mental ability severe enough to interfere with daily life. It affects memory, thinking, reasoning, and social abilities, making it difficult to perform everyday activities. The condition develops gradually and worsens over time, beginning with minor memory lapses and confusion. People with dementia may have trouble remembering recent events, recognizing familiar people and places, and finding the right words during conversation. As it progresses, individuals may experience changes in mood and behavior, difficulty making decisions, and problems with coordination. The decline in cognitive function varies in speed and severity depending on the underlying cause.

  • Tauopathies

    Tauopathies are a group of brain disorders characterized by the abnormal buildup of tau protein in brain cells. Tau proteins normally help stabilize structures within nerve cells, but in these conditions they become chemically altered and form harmful clumps. These abnormal protein deposits interfere with the normal functioning of brain cells and eventually cause them to die. The accumulation of tau proteins spreads gradually through different regions of the brain over time. As more brain cells are affected, individuals experience progressive problems with thinking, memory, movement, and behavior. The pattern and speed of progression varies depending on which specific tauopathy is present.

  • Neurodegenerative Diseases

    Neurodegenerative diseases are conditions in which nerve cells in the brain or nervous system progressively lose function and eventually die. These disorders develop slowly and worsen steadily over months or years as more nerve cells are damaged. The loss of nerve cells leads to problems with movement, coordination, strength, sensation, or mental functioning depending on which parts of the nervous system are affected. Early symptoms may be subtle and easily overlooked, but they become more noticeable as the disease advances. The progressive nature means that abilities and functions that were once normal gradually decline. Different neurodegenerative diseases affect different types of nerve cells and brain regions, leading to distinct patterns of symptoms.

  • Neurocognitive Disorders

    Neurocognitive disorders are conditions that primarily affect cognitive functions such as memory, thinking, and reasoning. These disorders result from changes in the brain that interfere with how nerve cells process and store information. Symptoms typically begin gradually with minor difficulties in remembering information or solving problems. As the condition progresses, individuals experience increasing trouble with attention, language, learning, and making decisions. Daily activities that require planning and organization become progressively more challenging. The severity ranges from mild impairment that causes noticeable difficulties to major impairment that significantly interferes with independence.

Trial detailsLast updated 11 Nov 2026
Age65+ yearsPhasePhase IIITrial ID2025-522340-40-00Protocol codeI5T-MC-AACOEstimated enrolment1 232 patientsSponsorEli Lilly & Co.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search on your own, or looking for clinical trials for a rare disease?

Tell us about your condition – we search every trial in Europe and connect you with the right site.