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Study on Lecanemab and Drug Combination for Patients with Early Onset Alzheimer's Disease Due to Genetic Mutation

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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 treatments for Early Onset Alzheimer's Disease, specifically a type called Dominantly Inherited Alzheimer's Disease (DIAD). This form of Alzheimer's is caused by a genetic mutation passed down through families. The study aims to explore whether certain treatments can slow down the progression of the disease or improve related health markers. The treatments being tested include several investigational drugs: PiB, MK-6240, Lecanemab, and E2814. These drugs are administered through injections or infusions, and their effects will be compared to a placebo.

The trial will involve participants who have a genetic mutation that causes Alzheimer's disease. The study will monitor the safety and tolerability of these treatments, as well as their impact on cognitive functions and disease-related biomarkers. Biomarkers are measurable indicators of the severity or presence of some disease state. Participants will receive the study drugs over a period of time, and their health will be assessed through various tests and evaluations, including brain imaging and cognitive assessments.

The goal is to determine if these treatments can effectively slow down the cognitive decline associated with Alzheimer's or improve certain biomarkers related to the disease. The study will also look at how these drugs interact with each other, especially when used in combination, such as E2814 with Lecanemab. The trial is designed to provide valuable insights into potential new therapies for those affected by this genetic form of Alzheimer's disease.

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

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria related to age, genetic mutation, and willingness to participate in study-related activities.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to establish baseline measurements. This includes cognitive tests, clinical evaluations, and biomarker assessments using imaging techniques such as PET and MRI scans.

  3. Step 3

    Treatment administration

    Participants receive treatments through intravenous administration. The medications include Lecanemab and E2814, both administered as solutions for infusion.

    The frequency and duration of administration are determined by the study protocol, with regular monitoring to assess safety and effectiveness.

  4. Step 4

    Ongoing assessments

    Throughout the study, participants undergo regular assessments every 26 weeks (~6 months). These include cognitive tests, clinical evaluations, and imaging studies to monitor changes in brain structure and function.

    Biomarker analyses are conducted to evaluate the impact of the treatment on Alzheimer's disease-related markers.

  5. Step 5

    Final evaluation

    At the end of the study period, a comprehensive evaluation is performed to assess the overall impact of the treatment on cognitive and clinical outcomes.

    The study aims to determine if the treatment slows the progression of symptoms or improves disease-related biomarkers.

Who can join the trial?

7 criteria

  • Participants must have a family history of **Dominantly Inherited Alzheimer Disease (DIAD)**, which means the disease is passed down from parent to child.
  • Participants should be within **-10 to +10 years** of the age when symptoms are expected to start, based on family history. This is for those who are in the **secondary prevention population**. They should have a **CDR** (Clinical Dementia Rating) score between 0 and 1, which measures the severity of dementia symptoms.
  • Participants can also be **11 to 25 years younger** than the age when symptoms are expected to start, for those in the **primary prevention population**. They should have a **CDR** score of 0, meaning no symptoms of dementia.
  • Participants must be a known carrier of the Alzheimer's-causing mutation or have a 50% risk due to an affected parent or sibling. If the at-risk parent is found not to carry the mutation, the participant will be removed from the study.
  • Participants must be willing to complete all the main tests, evaluations, and procedures required by the study.
  • Both **male and female** participants are eligible to join the study.
  • The study includes participants from **vulnerable populations**, which may include groups like children or those with limited decision-making capacity.

Who cannot join the trial?

4 criteria

  • Individuals who do not have a genetic mutation that causes **Dominantly Inherited Alzheimer Disease (DIAD)** cannot participate. This means the study is only for those with a specific genetic change linked to this type of Alzheimer's.
  • Participants must be within a certain age range. If you are not within the specified age group, you cannot join the study.
  • Both men and women can participate, but if you do not identify as either, you may not be eligible.
  • If you belong to a group considered vulnerable, such as those with certain health conditions or disabilities, you may not be able to participate.
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Investigated drugs

  • Gantenerumab

    is a medication being studied for its potential to slow down the progression of Alzheimer's disease. It works by targeting and removing amyloid plaques in the brain, which are believed to contribute to the symptoms and progression of Alzheimer's disease.

  • Solanezumab

    is another investigational drug in the trial, designed to bind to amyloid-beta proteins in the brain. By doing so, it aims to prevent these proteins from forming plaques, which are associated with the development and progression of Alzheimer's disease.

  • DIAN-TU-001

    is a code name for a study drug being tested in this trial. It is being evaluated for its ability to modify the disease process in individuals with a genetic mutation that causes Alzheimer's disease. The goal is to see if it can slow down cognitive decline or improve biomarkers related to the disease.

What is already known about the treatment

Investigational Alzheimer's Medication – This medication is administered orally and is currently being studied in clinical trials for its potential to modify the progression of Dominantly Inherited Alzheimer's Disease (DIAD). It is in the Phase II/III stage of clinical trials, where its safety, tolerability, and effectiveness are being evaluated. The main therapeutic indication is to slow cognitive decline and improve disease-related biomarkers in individuals with a genetic predisposition to Alzheimer's. At the molecular level, the medication is believed to work by targeting specific pathways involved in the disease's progression, potentially reducing the accumulation of harmful proteins in the brain. It is classified as a potential disease-modifying therapy for Alzheimer's disease.

Investigated diseases

Dominantly Inherited Alzheimer Disease (DIAD) – This is a rare form of Alzheimer's disease that is passed down through families in an autosomal dominant manner, meaning that inheriting just one copy of the mutated gene from an affected parent can cause the disease. It typically begins at a younger age than the more common sporadic form of Alzheimer's, often in a person's 30s to 50s. The disease progresses with the gradual decline in memory, thinking, and reasoning skills. As it advances, individuals may experience confusion, mood changes, and difficulty with language and movement. Over time, the ability to perform daily activities becomes increasingly impaired. The progression of symptoms can vary, but it generally follows a similar pattern to other forms of Alzheimer's disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-515198-91-00Protocol codeDIAN-TU-001Estimated enrolment175 patientsSponsorWashington University School Of Medicine

sourced from the EU Clinical Trials Register and site verification

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