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Study on the Safety and Effects of ACI-24.060 for Patients with Early Alzheimer's Disease and Adults with Down Syndrome

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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 Alzheimer's disease and its early stages, known as prodromal Alzheimer's disease, as well as in adults with Down syndrome. The study aims to evaluate a new treatment called ACI-24.060, which is administered as an injection. This treatment is being tested to see how safe and tolerable it is for patients, and to understand how it affects the body's immune response, particularly in producing antibodies against a protein associated with Alzheimer's disease.

The study involves several groups of participants who will receive either the new treatment, ACI-24.060, or a placebo. Additionally, some participants may receive other substances like [18F]PI-2620 and Neuraceq, which are solutions for injection used in imaging studies to help visualize certain brain changes. These substances are used to better understand the effects of the treatment on the brain. The study is designed to be adaptive, meaning it can change based on the results observed during the trial, and it is conducted in a way that neither the participants nor the researchers know who is receiving the actual treatment or the placebo, which is known as a double-blind study.

Participants will be monitored over a period of time to assess any side effects and to measure the body's response to the treatment. This includes regular health check-ups, brain imaging using MRI, and blood tests to evaluate the presence of antibodies. The study is expected to continue until 2026, providing valuable information on the potential benefits and safety of ACI-24.060 for individuals with early Alzheimer's disease and Down syndrome.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
Upon joining the study, an initial visit is conducted to confirm eligibility. This includes a review of medical history and a physical examination.
A PET scan is performed to check for amyloid pathology in the brain, which is a characteristic of Alzheimer's disease.
Step 2
Consent and baseline assessments
Written informed consent is obtained after explaining the study details. This ensures understanding and agreement to participate.
Baseline assessments are conducted, including cognitive tests and questionnaires to evaluate mental status and daily functioning.
Step 3
Treatment administration
Participants receive the study medication ACI-24.060 or a placebo through an intramuscular injection. The frequency and dosage are determined by the study protocol.
The treatment phase involves regular visits for administration and monitoring of the medication's effects.
Step 4
Regular monitoring
Regular follow-up visits are scheduled to monitor health and any side effects. This includes physical and neurological examinations.
Blood and urine tests are conducted to evaluate routine health markers and any changes due to the treatment.
Step 5
Imaging and assessments
Periodic brain MRI scans are performed to assess any changes in brain structure.
Additional cognitive assessments and questionnaires are completed to track changes in mental status and daily functioning.
Step 6
Final visit and study completion
A final visit is conducted to complete the study assessments and review overall health.
Participants are provided with information about the study's conclusion and any follow-up care if necessary.

Who can join the trial?

17 criteria

For Part 1: You must be between the ages of 50 and 85 at the time of screening.
For Part 2: You must be between the ages of 35 and 50 at the time of screening. If you have Down syndrome (DS), you can be between 35 and 39 years old if there is prior evidence of amyloid results compatible with Alzheimer's disease (AD) pathology in a PET scan or in biofluids.
For Part 2: You must be male or female with Down syndrome, confirmed by a genetic test showing either trisomy 21 or a complete unbalanced translocation of chromosome 21.
For Part 2: A PET scan at screening must show signs of amyloid pathology, which is related to Alzheimer's disease.
For Part 2: You, your legal representative (if applicable), and/or your study partner must be able to understand the study details and provide written consent before starting any study-related activities.
For Part 2: You, your legal representative (if applicable), and/or your study partner or informant must be able to fully participate in the study, speak the official language(s) of the country you live in, and be capable of completing study assessments reliably.
For Part 2: If you are a female, you must be either post-menopausal for at least 1 year, surgically sterilized, or if of childbearing potential, have a negative blood pregnancy test at screening and be willing to use highly effective contraception methods during the study. Male participants with female partners of childbearing potential must use barrier methods of contraception (like condoms with spermicide) in addition to the contraceptive measures used by their partners during the study.
For Part 2: You must have mild to moderate intellectual disability as per the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) classification.
For Part 2: You must have a study partner who has direct and regular contact with you for at least 10 hours per week and can provide reliable answers to questions related to you, according to the study investigator.
For Part 1: You must have a diagnosis of prodromal Alzheimer's disease, which means mild cognitive impairment (MCI) due to Alzheimer's disease, according to the National Institute on Aging-Alzheimer’s Association (NIA-AA) criteria.
For Part 1: A PET scan at screening must show signs of amyloid pathology, which is related to Alzheimer's disease.
For Part 1: You must have a Clinical Dementia Rating (CDR)-Global Score of 0.5, which indicates very mild dementia.
For Part 1: You must be able to understand the study details and provide written consent, in the opinion of the investigator.
For Part 1: You must either not be taking any marketed treatment for Alzheimer's disease or be on a stable dose of an acetylcholinesterase inhibitor (ACHEI) and/or memantine for at least 2 months before the start of the study.
For Part 1: You must be cared for by a reliable spouse, informant, or study partner who can assure compliance, assist with clinical assessments, and report safety issues. This person must consent to serve in this role.
For Part 1: If you are a female, you must be either post-menopausal for at least 1 year, surgically sterilized, or if of childbearing potential, have a negative blood pregnancy test at screening and be willing to use highly effective contraception methods during the study. Male participants with female partners of childbearing potential must use barrier methods of contraception (like condoms with spermicide) in addition to the contraceptive measures used by their partners during the study.
For Part 1: You and your study partner must be proficient in the official language(s) of the country you live in and able to comply with all study procedures, including lumbar punctures.

Who cannot join the trial?

4 criteria

Patients who do not have Alzheimer's disease cannot participate.
Patients who are not within the specified age range cannot participate.
Patients who belong to certain clinical trial groups that are not included in this study cannot participate.
Patients who are part of a vulnerable population that is not selected for this study cannot participate.

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Verified sites

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

Hospital Clinico San Carlos
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Madrid, Spain
Hospital De La Santa Creu I Sant Pau
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Barcelona, Spain
Hospital Universitario De La Princesa
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Madrid, Spain

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Investigated drugs

ACI-24.060 is a medication being studied for its potential to help people with early signs of Alzheimer's disease and adults with Down syndrome. This medication is designed to work by encouraging the body to produce antibodies against a protein called beta-amyloid, which is often found in the brains of people with Alzheimer's disease. The goal is to see if these antibodies can help reduce or prevent the buildup of this protein, which may slow down or improve symptoms of the disease. The study is focused on understanding how safe and tolerable this medication is for patients, as well as how well it can stimulate the body's immune response to target the beta-amyloid protein.

What is already known about the treatment

ACI-24.060 – ACI-24.060 is administered as an injection and is currently being studied in clinical trials for its potential use in treating Alzheimer's disease and in adults with Down syndrome. This medication is in the early stages of research, specifically in a phase 1b/2 trial, which means it is being tested for safety and how well it is tolerated by patients. The main goal of ACI-24.060 is to help the body produce antibodies against a protein called beta-amyloid, which is associated with Alzheimer's disease. By doing this, it aims to slow down or prevent the progression of the disease. ACI-24.060 falls under the category of immunotherapy, which is a type of treatment that uses the body's immune system to fight diseases.

Investigated diseases

Alzheimer's disease – Alzheimer's disease is a progressive neurological disorder that affects the brain, leading to memory loss and cognitive decline. It typically begins with mild memory lapses and confusion, which gradually worsen 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 disease is characterized by the accumulation of amyloid plaques and tau tangles in the brain, which disrupt communication between nerve cells. This disruption leads to the death of brain cells and a decline in brain function.