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Study on Thiethylperazine and Florbetaben (18F) for Early Alzheimer's Disease Patients

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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 Thiethylperazine in patients who have been newly diagnosed with early-to-mild dementia due to Alzheimer's Disease. The study aims to explore whether this medication can help improve the clearance of a protein called Aβ from the brain over a period of 12 months. This protein is often associated with the progression of Alzheimer's Disease. The trial will compare the effects of Thiethylperazine with a placebo to see if there are any significant differences in outcomes.

Participants in the study will receive either the medication or a placebo and will be monitored over the course of a year. The study will also use a special imaging technique called Florbetaben-PET to measure changes in the brain. This technique involves a solution for injection called Neuraceq, which helps visualize certain brain changes associated with Alzheimer's Disease. The trial will assess various health markers and cognitive functions to determine the effectiveness of the treatment.

The goal of this research is to better understand how Thiethylperazine might aid in diagnosing and treating early stages of Alzheimer's Disease. By participating in this study, researchers hope to gather valuable information that could lead to improved treatment options for individuals affected by this condition. The study is expected to continue until the end of 2027, with recruitment starting in late 2025.

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, the first step involves an initial visit. During this visit, a series of assessments will be conducted to confirm eligibility. These assessments include cognitive tests and a review of medical history.
A **Florbetaben-PET** scan, which is a type of brain imaging, will be performed if not done within the last 12 months. This scan helps in assessing the presence of certain proteins in the brain associated with Alzheimer's disease.
Step 2
Medication administration
Participants will be randomly assigned to receive either the study medication **thiethylperazine (TEP)** or a placebo. The medication is administered orally in the form of a coated tablet.
The dosage and frequency of the medication will be determined by the study protocol, and participants will be required to take the medication as instructed for a duration of 12 months.
Step 3
Regular follow-up visits
Throughout the 12-month period, regular follow-up visits will be scheduled. These visits are essential for monitoring the participant's health and the effects of the medication.
During these visits, various tests will be conducted, including cognitive assessments and blood tests, to evaluate the impact of the treatment.
Step 4
Final assessment
At the end of the 12-month treatment period, a final assessment will be conducted. This will include a repeat of the **Florbetaben-PET** scan to compare changes from the initial scan.
The final assessment will also involve a comprehensive evaluation of cognitive function and overall health to determine the effects of the treatment.

Who can join the trial?

19 criteria

Must be newly diagnosed with early-to-mild dementia due to Alzheimer's Disease.
Must be between the ages of 55 and 80.
Must be willing and able to sign a consent form approved by an ethics committee.
Must be willing and able to attend scheduled study visits, follow the treatment schedule, and complete laboratory and cognitive tests.
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Must have normal blood test results, including:
- Normal full blood count (a test that checks the types and numbers of cells in your blood).
- Normal kidney function (serum creatinine less than 1.5 times the upper limit of normal).
- Normal liver function (total bilirubin less than 1.5 times the upper limit of normal, and other liver enzymes within specified limits).
- Normal prolactin levels (a hormone).
- Fasting triglycerides (a type of fat in the blood) less than 2.5 times the upper limit of normal.
- If taking certain medications for Alzheimer's, must have been on a stable dose for at least 3 months before the study.
- If taking certain other medications, must stop them at least 4 weeks before starting the study.
- Must be in good general health with no other diseases that would interfere with the study.
- Must have someone who can provide information about them during the study.
- Must be fluent in German.
- Must have a specific type of brain scan (Florbetaben-PET) done within the last 12 months showing certain results.
- Must have been diagnosed with mild cognitive impairment due to Alzheimer's disease within the last 12 months, or have a specific score on a mental state exam.
- Must have a diagnosis of Alzheimer's based on specific examinations and criteria.
- Must be legally competent according to the investigator's opinion.
- Must agree to genetic testing for the APOE gene, or have known results from the past 24 months.

Who cannot join the trial?

10 criteria

Patients who have not been diagnosed with early-to-mild dementia due to Alzheimer's Disease cannot participate.
Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
Patients who are not able to provide informed consent or understand the study procedures cannot participate.
Patients with other serious health conditions that might interfere with the study cannot participate.
Patients who are currently participating in another clinical trial cannot participate.
Patients who have a history of allergic reactions to the study medication cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have a history of substance abuse or dependency cannot participate.
Patients who have had a major psychiatric disorder in the past year cannot participate.
Patients who have had a significant head injury or neurological disorder other than Alzheimer's Disease cannot participate.

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Verified sites

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

Verified
Central Institute of Mental Health
Mannheim, Germany
Verified
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH
Ulm, Germany
Responsive
Ludwig Maximilian University Of Munich
Munich, Germany

Trial locations

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Investigated drugs

Thiethylperazine is a medication being tested in this clinical trial to see if it can help people with early-stage Alzheimer's disease. The main goal is to find out if taking thiethylperazine for 12 months can help clear a protein called Aβ from the brain. This protein is often found in higher amounts in people with Alzheimer's disease, and reducing it might help slow down the disease's progression. The trial is focused on patients who have mild cognitive impairment or early dementia due to Alzheimer's disease. By participating in this trial, researchers hope to learn more about how thiethylperazine might benefit people with these conditions.

Florbetaben (18F)

What is already known about the treatment

Thiethylperazine – Thiethylperazine is administered orally in the form of tablets. It is currently being studied in clinical trials for its potential use in treating early-to-mild dementia due to Alzheimer's Disease. The main therapeutic indication is to improve the clearance of a protein called Aβ from the brain, which is associated with Alzheimer's. At the molecular level, thiethylperazine is believed to enhance the removal of this protein, potentially slowing the progression of dementia. It is classified pharmacologically as an antiemetic, but its role in Alzheimer's treatment is under investigation.

Investigated diseases

Alzheimer's Disease – Alzheimer's Disease is a progressive neurological disorder that leads to the degeneration of brain cells. It begins with mild memory loss and can progress to severe cognitive impairment. As the disease advances, individuals may experience confusion, disorientation, and difficulty with language and reasoning. Behavioral changes, such as mood swings and withdrawal from social activities, are also common. Over time, individuals may lose the ability to perform daily tasks independently. The disease primarily affects older adults, but early-onset forms can occur in younger individuals.