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Study on Bepranemab for Patients with Early Alzheimer's Disease

Fast replyRegistered drugNo placebo
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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 a treatment for people with early stages of Alzheimer's Disease. The treatment being tested is called Bepranemab (also known by its code name UCB0107), which is given as a solution through an infusion into the vein. The study also involves a comparison with a placebo, which is a substance that looks like the treatment but does not contain any active ingredients. Additionally, the study uses a special imaging technique with substances like (18F) GTP1 and Neuraceq to help visualize changes in the brain.

The purpose of the study is to evaluate how effective and safe Bepranemab is for people with early Alzheimer's Disease. Participants will receive either Bepranemab or a placebo and will be monitored over a period of time to see how their condition changes. The study will also include an open-label extension period, where all participants may receive Bepranemab. During the study, participants will undergo various assessments to track their cognitive abilities and overall health.

Throughout the study, researchers will use different methods to measure changes in the participants' condition, including the use of imaging techniques to observe the brain. The study aims to provide valuable information on the potential benefits and safety of Bepranemab for treating early Alzheimer's Disease.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant will be assessed to confirm eligibility based on specific criteria related to age, cognitive impairment, and other factors.

    The participant must have a diagnosis of early-stage Alzheimer's Disease and meet other health and cognitive criteria.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to establish a baseline for cognitive and functional abilities.

    This includes tests like the Clinical Dementia Rating and the Mini-Mental State Examination.

  3. Step 3

    Treatment phase

    The participant will receive either bepranemab or a placebo through intravenous infusion.

    The treatment will be administered regularly over a period of 80 weeks.

  4. Step 4

    Monitoring and assessments

    Throughout the study, the participant will undergo regular assessments to monitor cognitive function and overall health.

    These assessments will include various cognitive tests and brain imaging techniques.

  5. Step 5

    Safety evaluations

    The participant will be monitored for any adverse effects related to the treatment.

    Safety evaluations will be conducted to ensure the participant's well-being.

  6. Step 6

    End of treatment phase

    At the end of the 80-week treatment phase, a final assessment will be conducted to evaluate changes in cognitive and functional abilities.

    The participant's response to the treatment will be analyzed.

  7. Step 7

    Open-label extension

    Following the double-blind treatment phase, participants may enter an open-label extension period.

    During this period, all participants will receive bepranemab to further assess its long-term effects.

Who can join the trial?

8 criteria

  • Age between 50 to 80 years old.
  • Diagnosis of **prodromal** or **mild cognitive impairment (MCI)** due to **Alzheimer's Disease (AD)** or mild AD. Prodromal means early signs or symptoms of a disease.
  • A global **Clinical Dementia Rating (CDR)** score between 0.5 to 1.0 and a **CDR-Memory Box (CDRMB)** score of at least 0.5 at the start of the study. These scores help measure the severity of dementia.
  • Score of 85 or less in the **delayed recall** part of the **Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)** at the start. This test checks memory and thinking skills.
  • **Mini-Mental State Examination (MMSE)** score of 20 or higher at the start. This is a test that measures cognitive function.
  • Must have an **informant** who knows the participant well and can spend at least 5 hours per week with them. This person will provide information about the participant's mental, emotional, and daily living abilities.
  • At least 6 years of formal education after age 5 or work experience to rule out other mental issues besides Alzheimer's.
  • Evidence of **cerebral Aβ accumulation**, which means a build-up of a protein in the brain, shown by a positive **amyloid assessment** through a **positron emission tomography (PET) scan** or a specific **cerebrospinal fluid test**.

Who cannot join the trial?

9 criteria

  • Participants with any other serious medical condition that could interfere with the study.
  • Individuals who have had a recent major surgery or are planning to have one during the study period.
  • People with a history of drug or alcohol abuse within the past year.
  • Participants who are currently taking medications that might affect the study results.
  • Individuals with a known allergy to the study medication or its ingredients.
  • People who are pregnant or breastfeeding.
  • Participants who have been involved in another clinical trial within the last 30 days.
  • Individuals with a history of severe mental health disorders.
  • People who are unable to comply with the study procedures or follow-up visits.
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Investigated drugs

Bepranemab (UCB0107) is a medication being studied for its potential to help people with early stages of Alzheimer's Disease. The trial aims to see if Bepranemab can improve symptoms related to memory and thinking abilities. Participants will receive this medication to evaluate its effectiveness and safety over a period of time.

What is already known about the treatment

Bepranemab – Bepranemab is administered as an injection and is currently being studied in clinical trials for its potential use in treating Alzheimer's Disease, specifically in its early stages. The medication is not yet widely recognized in medical literature as it is still under investigation. It is intended to help manage symptoms of Alzheimer's by targeting specific proteins in the brain that are believed to contribute to the disease's progression. Bepranemab is classified as a monoclonal antibody, which means it is designed to bind to and neutralize specific molecules involved in the disease process.

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, gradually worsening 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 exact cause of Alzheimer's is not fully understood, but it involves the accumulation of proteins in the brain, leading to cell damage. The progression of symptoms varies among individuals, but it generally follows a slow and steady decline.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-506170-12-00Protocol codeAH0003Estimated enrolment466 patientsSponsorUCB Biopharma

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).