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Study on the Safety and Effects of Hydroxypropylbetadex Infusions in Patients with Early Alzheimer's Disease

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 Early Alzheimer's Disease, a condition that affects memory and thinking skills. The study will use a treatment called Trappsol Cyclo, which contains the active substance hydroxypropylbetadex. This treatment is given as a solution for infusion, meaning it is administered directly into the bloodstream through a vein.

The purpose of the study is to evaluate the safety and potential benefits of Trappsol Cyclo in patients with early Alzheimer's Disease. Participants in the study will receive monthly infusions of the treatment over a period of six months. Some participants will receive a placebo instead of the actual treatment. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the treatment or the placebo, to ensure unbiased results.

Throughout the study, researchers will monitor participants for any side effects and assess how well the treatment is tolerated. They will also explore the potential effectiveness of Trappsol Cyclo in improving symptoms of early Alzheimer's Disease. The study will help determine how the body processes the treatment over the 24-week period. Participants will undergo various assessments, including MRI scans and hearing tests, to ensure their safety and gather comprehensive data on the treatment's impact.

The research process

The trial runs in 4 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, you will undergo a series of assessments to confirm your eligibility for the trial. These assessments may include cognitive tests, physical examinations, and laboratory tests such as blood and urine analysis.
You will receive detailed information about the study, including the potential risks and benefits. You will have the opportunity to ask any questions you may have before providing your consent to participate.
Step 2
Monthly infusion
Once you are enrolled in the study, you will receive a monthly infusion of the study medication, Trappsol Cyclo, or a placebo. The infusion will be administered through a vein, a process known as an infusion.
Each infusion session will last for a few hours, during which you will be monitored for any immediate reactions to the medication.
Step 3
Regular assessments
Throughout the 6-month study period, you will undergo regular assessments to monitor your health and the effects of the treatment. These assessments will include cognitive tests to evaluate your memory and thinking abilities, as well as physical examinations and laboratory tests.
You will also be asked about any side effects or changes in your health that you may experience during the study.
Step 4
Final visit
At the end of the 6-month study period, you will attend a final visit. During this visit, you will undergo a comprehensive assessment similar to the initial visit to evaluate the overall impact of the treatment.
You will have the opportunity to discuss your experience in the study and any concerns you may have with the study team.

Who can join the trial?

4 criteria

Must be a male or female between 50 to 80 years old at the time of giving consent to participate.
Must have at least an eighth-grade education.
If you are a patient based in the United States, your primary language must be English, and you should be able to understand and read English well enough to complete study procedures, including all cognitive tests.
Must have Mild Cognitive Impairment (MCI) due to Alzheimer's Disease, which is considered Stage 3 according to the FDA guidelines. This means you have some memory or thinking problems that are noticeable but do not interfere significantly with daily life.

Who cannot join the trial?

10 criteria

Patients with any other serious medical 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 any of the study medications.
Patients who are pregnant or breastfeeding.
Patients with a history of drug or alcohol abuse within the past year.
Patients who are unable to comply with the study procedures.
Patients with a known infection that could affect the study results.
Patients who have been diagnosed with a psychiatric disorder that is not well controlled.
Patients with a history of cancer, except for certain types of skin cancer that have been treated successfully.

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Verified sites

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

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Medical University Of Graz
Graz, Austria
Verified
University Hospital Cologne
Cologne, Germany

Trial locations

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Investigated drugs

Trappsol Cyclo is a medication being studied for its potential to help people with early Alzheimer's disease. It is given as an infusion, which means it is delivered directly into the bloodstream through a vein. The main goal of using Trappsol Cyclo in this study is to see if it is safe and well-tolerated by patients over a period of six months. Researchers are also looking to see if it might help improve symptoms of Alzheimer's disease during this time. Additionally, they are studying how the body processes the medication, which is known as pharmacokinetics. This information will help determine if Trappsol Cyclo could be a useful treatment for Alzheimer's disease in the future.

Hydroxypropylbetadex

What is already known about the treatment

Trappsol Cyclo – Trappsol Cyclo is administered as a monthly infusion, meaning it is delivered directly into the bloodstream through a vein. It is currently being studied in clinical trials for its safety, tolerability, and potential effectiveness in treating early Alzheimer's disease. The main therapeutic indication for Trappsol Cyclo is early Alzheimer's disease, a condition that affects memory and cognitive function. At the molecular level, Trappsol Cyclo works by interacting with cholesterol and other lipids in the brain, potentially helping to clear harmful substances that contribute to Alzheimer's disease. It is classified pharmacologically as a hydroxypropyl beta cyclodextrin, a type of compound that can bind to and transport cholesterol.

Investigated diseases

Early Alzheimer's Disease – Early Alzheimer's Disease is a neurodegenerative condition characterized by mild memory loss and cognitive decline. It primarily affects the brain's ability to process information, leading to difficulties in remembering recent events or conversations. As the disease progresses, individuals may experience confusion, disorientation, and challenges in completing familiar tasks. Changes in mood and personality, such as increased anxiety or irritability, are also common. The progression of the disease involves a gradual worsening of symptoms, impacting daily life and independence. Over time, the cognitive and functional abilities continue to decline, requiring increased support and care.