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 study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliero Universitaria Careggi Florence Italy

Other Sites

Site Name City Country Status
Brain Research Center Amsterdam B.V. Amsterdam The Netherlands
Deutsches Zentrum Fuer Neurodegenerative Erkrankungen e.V. Bonn Germany
Hospital Clinic De Barcelona Barcelona Spain
Provincia Lombardo Veneta Dell’ordine Ospedaliero Di San Giovanni Di Dio Fatebenefratelli Brescia Italy
Sh Vwweikpsybtfvjw Utjebfgalk Hloxapsk Dublin Ireland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
13.07.2014
Ireland Ireland
Not recruiting
13.07.2014
Italy Italy
Not recruiting
13.07.2014
Spain Spain
Not recruiting
13.07.2014
The Netherlands The Netherlands
Not recruiting
13.07.2014

Trial locations

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.

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 ID:
2024-515198-91-00
Protocol code:
DIAN-TU-001
NCT ID:
NCT01760005
Trial Phase:
Therapeutic use (Phase IV)

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