Study on Lecanemab for Patients with Dominantly Inherited Alzheimer’s Disease to Evaluate Prevention and Progression

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What is this study about?

This clinical trial is focused on studying Dominantly Inherited Alzheimer’s Disease (DIAD), a rare form of Alzheimer’s that is passed down through families. The study will use a treatment called Lecanemab, which is a medication designed to be given as an infusion, meaning it is delivered directly into the bloodstream through a vein. The purpose of the study is to evaluate how removing a protein called amyloid affects the onset and progression of this type of Alzheimer’s disease.

Participants in the study will receive Lecanemab and will be monitored over time to see how the treatment impacts their condition. The study will compare the results of those receiving the treatment to external controls, which are groups of people not receiving the treatment, to understand its effects better. The study will involve regular assessments, including imaging tests like PET scans, which help visualize the brain, and other clinical evaluations to track changes in the disease.

The trial will last several years, with participants undergoing various tests and assessments to gather information on how Lecanemab affects the progression of Dominantly Inherited Alzheimer’s Disease. The study aims to provide insights into whether this treatment can delay the onset or slow the progression of symptoms in individuals with this genetic form of Alzheimer’s. Participants will be closely monitored throughout the study to ensure their safety and to collect valuable data on the treatment’s effectiveness.

1 entry into the study

Upon joining the study, participation begins with an initial visit, referred to as Visit 2. During this visit, eligibility is confirmed, including a check of the Body Mass Index (BMI) to ensure it is greater than 17 and less than 35.

A study partner must be identified. This person will support throughout the study and provide follow-up information. The study partner must spend at least 8 hours per week with the participant.

2 medication administration

The study involves the administration of the medication lecanemab. This is provided as a concentrate for solution for infusion, which means it is given through an injection.

The frequency and dosage of the medication will be determined by the study protocol and administered by healthcare professionals.

3 ongoing assessments

Throughout the study, regular assessments will be conducted to monitor progress. These include imaging tests such as amyloid PET scans and tau PET scans, which help visualize changes in the brain.

Clinical assessments will also be performed, including the Functional Assessment Scale, to evaluate any changes in daily functioning.

4 safety monitoring

Safety is a priority, and regular MRI scans will be conducted to ensure there are no adverse effects from the medication.

Vascular access will be checked to ensure it is adequate for the administration of the study drug and for safety monitoring.

5 study duration

The study is expected to continue until May 2030. Participation involves regular visits and assessments throughout this period.

Participants are required to co-enroll in the DIAN Observational Study and complete its procedures and assessments.

Who Can Join the Study?

Previously participated in the DIAN-TU-001 gantenerumab OLE period.
Willing to participate in ongoing anti-amyloid therapy with informed consent by participant or legally authorized representative.
People of childbearing potential (POCBP), if partner is not sterilized, must agree to use highly effective contraceptive measures. These methods should have a failure rate of less than 1% per year when used consistently and correctly from the start of the study until eight weeks after the last dose of any study drug. Such methods include:
- Combined hormonal contraception (estrogen and progestogen) that stops ovulation, available as oral, intravaginal, or transdermal options.
- Progestogen-only hormonal contraception that stops ovulation, available as oral, injectable, or implantable options.
- Intrauterine device (IUD)
- Intrauterine hormone-releasing system (IUS)
- Bilateral tubal occlusion (a permanent method of birth control)
- Vasectomized partner (a partner who has had a vasectomy)
- Sexual abstinence (not having sexual intercourse)
Co-enrollment in the DIAN Observational Study (DIAN Obs, NCT00869817) and willing to complete DIAN Obs procedures and assessments.
Able to undergo safety MRI scans as required. MRI stands for Magnetic Resonance Imaging, a type of scan used to create detailed images of the inside of the body.
Vascular access adequate for study drug administration and safety monitoring. This means having suitable veins for receiving the study medication and for monitoring safety.
Body Mass Index (BMI) greater than 17 and less than 35 at Visit 2 (Entry Visit). BMI is a measure of body fat based on height and weight.
Have an identified study partner. This is a person who can support the participant for the duration of the study and spends at least 8 hours per week with them. The study partner must provide separate written informed consent and be willing and able to provide follow-up information on the participant throughout the study. The study partner does not need to live with the participant but should be easily reachable.

Who Cannot Join the Study?

Patients who do not have Dominantly Inherited Alzheimer Disease (DIAD) cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are not part of the specified clinical trial groups cannot participate.
Patients who are considered part of a vulnerable population may not be eligible to participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire Rouen	Rouen	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	27.11.2024

Trial locations

Investigated drugs:

Lecanemab

Lecanemab is a medication being studied for its potential to help with 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 play a role in the development and progression of the disease. By removing amyloid, lecanemab aims to slow down or prevent the symptoms of Alzheimer’s, such as memory loss and confusion, from getting worse. This trial is exploring how effective lecanemab is in delaying the onset and progression of Alzheimer’s in people who are at risk due to their family history.

Investigated diseases:

Dementia Alzheimer's type

Dominantly Inherited Alzheimer Disease (DIAD) – This is a genetic form of Alzheimer’s disease that is passed down through families. It is characterized by the early onset of symptoms, typically before the age of 65. The disease progresses with the accumulation of amyloid plaques and tau tangles in the brain, leading to the degeneration of brain cells. As the disease advances, individuals experience memory loss, confusion, and difficulties with thinking and reasoning. Over time, these cognitive impairments worsen, affecting daily functioning and independence. The progression of the disease is marked by a decline in cognitive abilities and changes in behavior and personality.

Trial ID:

2024-513458-31-00

Protocol code:

DIAN-TU-003

NCT ID:

NCT06384573

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on Lecanemab for Patients with Dominantly Inherited Alzheimer’s Disease to Evaluate Prevention and Progression

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