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Study on the Effects of ALZ-801 in Patients Aged 50-80 with Early Alzheimer's Disease and APOE4 Genotype

Verified siteInvestigationalNo 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 the effects of a medication called ALZ-801 on individuals with Alzheimer's disease who carry a specific genetic variant known as APOE4. Alzheimer's disease is a condition that affects memory and thinking skills, and this study is particularly interested in those who are in the early stages of the disease. The medication being tested, ALZ-801, is taken in the form of a tablet and is designed to be taken orally.

The purpose of the study is to evaluate how ALZ-801 affects certain biological markers in the blood and brain, which are related to Alzheimer's disease. These markers include proteins like p-tau181, which is associated with the disease's progression, and changes in brain structures such as the hippocampus, a region important for memory. Participants in the study will undergo various tests, including blood tests and brain scans like MRI (Magnetic Resonance Imaging), to monitor these changes over time.

The study will take place over several years, with participants receiving the medication and undergoing regular assessments to track any changes in their condition. The goal is to understand how ALZ-801 might help in managing Alzheimer's disease by observing its impact on these biological markers and brain structures. This research could provide valuable insights into potential treatments for those affected by this challenging condition.

The research process

The trial runs in 7 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, physical examination, and laboratory tests.
A brain MRI is performed to ensure it aligns with the diagnosis of Alzheimer's disease.
Step 2
Baseline measurements
Baseline measurements are taken, including cognitive tests and blood samples to measure biomarkers related to Alzheimer's disease.
A lumbar puncture may be performed to collect cerebrospinal fluid for further biomarker analysis.
Step 3
Medication administration
The medication ALZ-801 is administered orally in tablet form. The dosage is determined based on the study protocol and may be adjusted over time.
Participants are required to take the medication as prescribed throughout the study duration.
Step 4
Regular follow-up visits
Regular follow-up visits are scheduled to monitor health, assess cognitive function, and collect blood samples for biomarker analysis.
These visits occur at specified intervals, such as every few weeks or months, as outlined in the study schedule.
Step 5
Imaging assessments
Imaging assessments, including MRI scans, are conducted periodically to evaluate changes in brain structure, particularly the hippocampal volume.
These assessments help track the progression of Alzheimer's disease and the effects of the medication.
Step 6
Long-term extension
Participants who complete the initial study phase may be eligible for a long-term extension, allowing continued access to the medication and monitoring.
This phase includes additional assessments and follow-up visits to gather long-term data on the medication's effects.
Step 7
Final evaluation
At the end of the study, a final evaluation is conducted to assess overall health, cognitive function, and biomarker levels.
Participants may receive information about their individual results and the study's findings.

Who can join the trial?

21 criteria

Must be between the ages of 50 and 80 years.
Must be willing to sign a consent form, which is a document that shows you understand the study and agree to participate. If you cannot sign, a legal representative can do it for you.
Must be able to complete cognitive tests, which are exercises to check your thinking and memory skills. You should have good enough vision and hearing to do these tests.
Must live independently at home, in a senior living facility, or in an assisted living facility.
Both you and your caregiver or study partner must be able to read and speak the local language used in the study.
You and your caregiver or study partner must agree to follow the study procedures and are likely to complete the study.
Your caregiver or study partner must agree not to give you any medications that are not allowed during the study.
If you are female, you must have a negative pregnancy test and either be unable to have children or use a highly effective method of birth control during the study.
Must have a brain MRI scan that supports the diagnosis of Alzheimer's disease and is of good quality. An MRI is a type of scan that takes pictures of your brain.
If you are taking a medication called an AChEI, you must have been on a stable dose for at least 12 weeks before the study and continue the same dose during the study. Memantine, another medication, is not allowed.
Must be in good general health, except for having Alzheimer's disease, based on medical history, physical exams, lab tests, vital signs, and heart tests (ECG).
Must weigh at least 50 kg (about 110 pounds).
If you are taking antidepressants or other mood-related medications, you must be on a stable dose.
If you are taking other allowed medications for non-excluded conditions, you must be on a stable dose.
Must have a diagnosis of probable Alzheimer's disease dementia or mild cognitive impairment (MCI) due to Alzheimer's disease.
Must have a biomarker profile that indicates Alzheimer's disease. Biomarkers are substances in your body that can show if you have a disease.
Must be willing to have a lumbar puncture (LP) for testing cerebrospinal fluid (CSF), which is a fluid around your brain and spine.
Must have a specific genetic type called APOE4/4 or APOE3/4. This is related to a gene that can affect Alzheimer's disease.
Must have a Mini-Mental State Examination (MMSE) score between 22 and 30. This is a test that measures your mental abilities.
Must have a Clinical Dementia Rating (CDR) Global Score of 0.5 or 1, and a CDR Memory Box Score of at least 0.5. These scores help assess the severity of dementia.
Must have a reliable caregiver or study partner who can sign a consent form, accompany you to study visits, and follow study requirements.

Who cannot join the trial?

10 criteria

Individuals who do not have a clinical diagnosis of Alzheimer's disease.
Individuals who are not carriers of the APOE 4 gene variant. This means they do not have the specific genetic makeup (APOE4/4 or APOE3/4) required for the study.
Individuals who are not in the early stage of Alzheimer's disease.
Individuals who are younger than 50 years old or older than 80 years old.
Individuals who are not willing or able to comply with the study procedures.
Individuals who have other medical conditions that might interfere with the study results.
Individuals who are pregnant or breastfeeding.
Individuals who are participating in another clinical trial.
Individuals who have a history of drug or alcohol abuse.
Individuals who have a serious mental illness that could affect their ability to participate in the study.

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Verified sites

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Fakultni Nemocnice U Sv Anny V Brne
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Brno-Stred, Czechia
Fakultni nemocnice Motol a Homolka
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Prague, Czechia

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Investigated drugs

ALZ-801 is an investigational medication being studied for its potential effects on early Alzheimer's disease. It is designed to be taken orally and is being evaluated for its impact on specific biomarkers related to Alzheimer's disease, particularly in individuals who carry certain genetic variants (APOE4/4 or APOE3/4). The study aims to understand how ALZ-801 affects proteins in the blood that are associated with Alzheimer's and how it might influence brain structures, such as the hippocampus, which is important for memory.

Valiltramiprosate

What is already known about the treatment

ALZ-801 – ALZ-801 is an oral medication currently being studied in clinical trials for its effects on Alzheimer's disease, specifically in individuals who carry the APOE4 gene variant. It is in the Phase 2 stage of clinical trials, focusing on its impact on biomarkers related to Alzheimer's pathology and brain volume. The main therapeutic indication for ALZ-801 is the treatment of early-stage Alzheimer's disease in patients aged 50-80 who are APOE4 carriers. The drug works by targeting and reducing the accumulation of amyloid proteins in the brain, which are believed to contribute to the progression of Alzheimer's disease. ALZ-801 is classified as an anti-amyloid agent, aiming to modify the disease process rather than just alleviate symptoms.

Investigated diseases

Alzheimer's Disease – Alzheimer's disease is a progressive neurological disorder that affects memory, thinking, and behavior. It is characterized by the accumulation of amyloid plaques and tau tangles in the brain, leading to the death of brain cells. In the early stages, individuals may experience mild memory loss and confusion. As the disease progresses, symptoms worsen, including severe memory impairment, disorientation, and difficulty in speaking and swallowing. The progression of Alzheimer's disease varies among individuals, but it generally leads to a decline in cognitive and functional abilities. The disease primarily affects older adults, typically those aged 65 and older, but can also occur in younger individuals.