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Study on the Effects of AD04 and Placebo in Patients with Early Alzheimer's Disease

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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 the effects of a treatment called AD04 on patients with early Alzheimer's disease. Alzheimer's disease is a condition that affects the brain, leading to memory loss and difficulties with thinking and daily activities. The treatment being tested, AD04, is a solution for injection that contains a substance called aluminium hydroxide. The study will compare the effects of AD04 with a placebo to see if it can help slow down the progression of Alzheimer's disease.

The purpose of the study is to assess whether AD04 can slow the progression of Alzheimer's disease by evaluating improvements in cognitive abilities, daily functioning, and overall health over a period of six months. Participants in the study will receive either the AD04 treatment or a placebo through subcutaneous injections, which means the injection is given under the skin. The study will be conducted in a way that neither the participants nor the researchers know who is receiving the actual treatment or the placebo, ensuring unbiased results.

Throughout the study, participants will undergo various assessments to monitor their cognitive function, daily activities, and overall well-being. These assessments will include tests like the Mini-Mental State Examination (MMSE) and brain imaging using MRI to check for changes in brain structure. The study will also track any side effects or adverse events that may occur during the treatment period. The goal is to determine if AD04 can provide meaningful benefits to patients with early Alzheimer's disease, potentially improving their quality of life and slowing the disease's progression.

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 visit
Upon joining the study, you will attend an initial visit. During this visit, a healthcare professional will review your medical history and conduct a physical examination to ensure you meet the study criteria.
You will be asked to provide written informed consent for study-related procedures and genetic investigations. This means you agree to participate in the study and understand what it involves.
Step 2
Baseline assessments
You will undergo several assessments to establish a baseline for your cognitive and functional abilities. These assessments include tests to evaluate your memory, daily activities, and overall cognitive function.
A brain MRI will be performed to assess any changes in brain structure, particularly in the medial temporal lobe, which is important for memory.
Step 3
Treatment administration
You will be randomly assigned to receive either the study medication AD04 or a placebo. The medication is administered as a solution for injection under the skin, known as subcutaneous use.
The dosage and frequency of administration will be determined by the study protocol, and you will be informed of the schedule during your visits.
Step 4
Regular follow-up visits
You will attend regular follow-up visits over a period of 6 months. During these visits, healthcare professionals will monitor your health and assess the effects of the treatment.
These visits will include cognitive and functional assessments, as well as monitoring for any side effects or adverse events related to the treatment.
Step 5
Final assessment
At the end of the 6-month period, you will undergo a final assessment. This will include the same tests and evaluations conducted at the baseline to measure any changes in your condition.
The results will help determine the efficacy of the treatment in slowing the progression of early Alzheimer's disease.

Who can join the trial?

10 criteria

Aged between 50 and 85 years old.
Must have a partner or caregiver who knows the patient well and can accompany them to visits. This person should be in frequent contact with the patient, at least 10 hours per week, and be available by phone at certain times.
Women who can have children and men with female partners who can have children must use two effective methods of birth control during the trial and for at least 90 days after the last dose. Men should not donate sperm during the trial and for at least 90 days after the last dose.
Must have a diagnosis of probable Alzheimer's disease based on specific criteria that include both clinical and brain-related assessments.
Must have a score between 22 and 30 on the Mini-Mental State Examination (MMSE), a test that measures cognitive function.
Must have a brain MRI showing atrophy (shrinkage) in a specific part of the brain, or have a specific pattern in cerebrospinal fluid (CSF) tests related to Alzheimer's disease.
Must have results from a memory test called the Free and Cued Selective Reminding Test (FCSRT) that indicate memory problems related to the hippocampus, a part of the brain important for memory.
Must have a physical examination, including vision and hearing tests, that are within the acceptable range for their age to allow for cognitive testing.
Must have a score of 4 or less on the Hachinski Ischemia Scale, which helps distinguish Alzheimer's disease from other types of dementia caused by blood vessel problems.
Must provide written informed consent for study-related procedures and genetic investigations, signed and dated by both the patient and the caregiver.

Who cannot join the trial?

10 criteria

Patients with any other serious health condition that might interfere with the study.
Patients who are currently participating in another clinical trial.
Patients who have had a recent major surgery or are planning to have surgery during the study period.
Patients with a history of severe allergic reactions to medications.
Patients who are unable to comply with the study procedures.
Patients with a history of drug or alcohol abuse.
Patients who are pregnant or breastfeeding.
Patients with unstable or serious mental health conditions.
Patients who have been diagnosed with a different type of dementia.
Patients who have had a stroke or other significant brain injury.

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Promente Sp. z o.o.
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Bydgoszcz, Poland

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Investigated drugs

AD04 is a medication being studied for its potential to help people with early Alzheimer's disease. Alzheimer's disease is a condition that affects the brain, leading to problems with memory, thinking, and behavior. The goal of using AD04 in this study is to see if it can slow down the worsening of these symptoms over time. Researchers are looking at how well AD04 can help maintain the patient's ability to think, perform daily activities, and overall well-being over a period of six months.

Aluminium Hydroxide

What is already known about the treatment

AD04 – AD04 is administered orally in the form of a pill and is currently being studied in clinical trials for its potential use in treating early Alzheimer's disease. The medication is not yet widely recognized in medical practice, as it is still under investigation to determine its safety and effectiveness. The main therapeutic goal of AD04 is to slow down the progression of early Alzheimer's disease, which affects memory and cognitive functions. At the molecular level, AD04 is believed to work by targeting specific pathways in the brain that are involved in the disease's progression, although the exact mechanism is still being researched. It falls under the pharmacological classification of investigational drugs, as it is not yet approved for general medical use.

Investigated diseases

Early Alzheimer's Disease – Early Alzheimer's disease is a neurodegenerative condition that primarily affects memory and cognitive function. It begins with mild memory loss and can progress to more significant impairments in thinking and reasoning. As the disease advances, individuals may experience difficulties with language, disorientation, and changes in mood or behavior. The progression involves the gradual decline of cognitive abilities, impacting daily activities and independence. Over time, the disease can lead to more severe memory loss and confusion. The changes in the brain associated with early Alzheimer's disease are thought to be linked to the accumulation of abnormal protein deposits.