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Study on the Effects of Sabirnetug for Patients with Early Alzheimer's Disease

Verified siteRegistered 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 Early Alzheimer’s Disease, which includes mild cognitive impairment and mild dementia due to Alzheimer's. The trial aims to evaluate the effectiveness and safety of a treatment called Sabirnetug, which is given through an intravenous infusion. The study will compare the effects of Sabirnetug with a placebo to see if it can slow down the decline in thinking and daily functioning abilities over a period of 80 weeks.

Participants in the study will receive either Sabirnetug or a placebo. The treatment involves regular infusions every four weeks. The study will monitor changes in participants' cognitive abilities and daily living skills using a scale called the Integrated Alzheimer’s Disease Rating Scale (iADRS). This scale helps measure how well participants are doing in terms of memory, thinking, and daily activities.

In addition to Sabirnetug, the study will also involve the use of other medications like Vizamyl, Neuraceq, and Amyvid, which are solutions for injection used in imaging tests to detect amyloid plaques in the brain, a hallmark of Alzheimer's disease. These imaging tests help confirm the presence of Alzheimer's-related changes in the brain. The study will last for approximately 80 weeks, during which participants will undergo various assessments to track their progress and the effects of the treatment.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial Assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current medications.
Eligibility criteria include age between 50 and 90 years, stable doses of any Alzheimer's medications for at least three months, and a reliable study partner.
Step 2
Baseline Evaluation
A baseline evaluation is performed to establish initial cognitive and functional status. This involves tests such as the Mini-Mental State Examination (MMSE) and the Integrated Alzheimer’s Disease Rating Scale (iADRS).
Evidence of cerebral amyloid accumulation is assessed through a PET scan or CSF analysis, if applicable.
Step 3
Randomization and Treatment
Participants are randomly assigned to receive either the study drug sabirnetug or a placebo. The study is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.
The treatment involves intravenous infusions of sabirnetug every four weeks (Q4W).
Step 4
Regular Monitoring
Participants attend regular study visits for monitoring. These visits include cognitive and functional assessments, as well as safety evaluations.
The primary endpoint is the change in the iADRS score from baseline to week 80.
Step 5
Completion of Study
The study concludes at week 80. Final assessments are conducted to evaluate changes in cognitive and functional abilities.
Participants are informed of their treatment group after the study ends.

Who can join the trial?

14 criteria

Age between 50 and 90 years old at the time of signing the consent form.
Able to provide written consent to participate in the study.
Body weight must be at least 30 kg (66 lbs) and no more than 160 kg (352 lbs) at the start of the study.
Agree to have a test to check for a specific genetic marker called **APOE4 genotype**.
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Meet specific criteria for early Alzheimer's disease, which includes:
- Having mild cognitive impairment or mild dementia due to Alzheimer's disease.
- Scoring between 22 and 30 on a test called the **Mini-Mental State Examination (MMSE)**.
- Scoring 0.5 or 1.0 on the **Clinical Dementia Rating (CDR)** scale and at least 0.5 on the **CDR Memory Box** score.
- Showing evidence of a protein buildup in the brain called **cerebral amyloid**, detected by a brain scan or a fluid test.
- If taking medications called **cholinesterase inhibitors** or **memantine** for Alzheimer's symptoms, doses must be stable for at least three months before starting the study.
- If taking blood thinners (anticoagulants), the treatment must be stable for at least one month before starting the study, and participants cannot have certain fluid tests due to bleeding risks.
- Must have a reliable person, like a family member or friend, who can support and accompany them to study visits or be available by phone.
- Individuals who could have children must be infertile due to surgery or be post-menopausal, meaning they haven't had a period for 12 months for reasons other than medical conditions.
- Men in relationships with women who can have children must use effective birth control, like condoms, and not donate sperm during the study and for 180 days after the last dose of the study drug.
- Willing and able to attend scheduled visits, follow the treatment plan, and undergo tests and other study procedures.

Who cannot join the trial?

7 criteria

Patients with any other type of dementia besides Alzheimer's Disease cannot participate. Dementia is a condition that affects memory and thinking skills.
Patients with serious medical conditions that could interfere with the study results are excluded. This means if you have a health issue that might affect how the treatment works, you cannot join.
Patients who have had a recent heart attack or stroke are not allowed to participate. A heart attack is when blood flow to the heart is blocked, and a stroke is when blood flow to the brain is interrupted.
Patients who are currently taking certain medications that might interfere with the study treatment cannot join. This means if you are on specific drugs that could affect the study, you will be excluded.
Patients with a history of drug or alcohol abuse in the past year are not eligible. This refers to using substances in a way that is harmful to your health.
Patients who are pregnant or breastfeeding cannot participate. This is to ensure the safety of both the mother and the baby.
Patients who have participated in another clinical trial within the last 30 days are excluded. This is to avoid any interference from other treatments.

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Verified sites

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

Verified
Assistance Publique Hopitaux De Marseille
Marseille, France
Verified
Central Institute of Mental Health
Mannheim, Germany
Verified
Centre Hospitalier Lyon Sud
Pierre Benite, France

Trial locations

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Investigated drugs

Sabirnetug is an investigational medication being studied for its potential to slow down cognitive and functional decline in individuals with early Alzheimer's disease. It is administered through an intravenous infusion every four weeks. The goal of the trial is to assess how effective and safe this medication is in comparison to a placebo, by measuring changes in a specific Alzheimer's disease rating scale over a period of 80 weeks.

What is already known about the treatment

Sabirnetug – Sabirnetug is administered intravenously, typically once every four weeks, as part of its application in clinical settings. It is currently being studied in a Phase 2 clinical trial to assess its effectiveness and safety in treating early Alzheimer's disease, specifically targeting mild cognitive impairment and mild dementia due to Alzheimer's. The main therapeutic indication for Sabirnetug is to slow cognitive and functional decline in patients with early Alzheimer's disease. At the molecular level, Sabirnetug is believed to work by modulating pathways involved in neurodegeneration, although the precise mechanism is still under investigation. It is classified pharmacologically as a potential treatment for neurodegenerative disorders.

Investigated diseases

Early Alzheimer's Disease – This condition is characterized by mild cognitive impairment and mild dementia due to Alzheimer's disease. It begins with subtle memory loss and difficulty in thinking or reasoning. As it progresses, individuals may experience increased confusion, trouble with language, and changes in mood or behavior. Daily tasks become more challenging, and there may be noticeable lapses in judgment. Over time, these symptoms gradually worsen, affecting the person's ability to function independently.