Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2 Theranostic Trial Evaluating the Effects of Thiethylperazine in Patients Diagnosed with an Early Stage of Alzheimer's disease

This research trial is for people who have recently been diagnosed with early stages of Alzheimer's disease. It's a 'Phase 2' study, which means it's an early-stage test of a potential new treatment. The main aim is to see how a medicine called 'thiethylperazine' affects changes in the brain that are typical of Alzheimer's. Researchers will use special brain scans, called Florbetaben-PET scans, at the beginning and after 12 months to measure these changes. They will also look at blood tests for specific markers related to Alzheimer's, and assess memory, thinking abilities, and quality of life. The study compares the new medicine with a 'dummy' pill (placebo) to understand its effects better.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Immungenetics AG

Enrolment target

228

Start

02 Nov 2022

Newly diagnosed early-to-mild dementia due to Alzheimer's Disease

What is this study about?

This study is a medical research project for people with early-stage Alzheimer's disease. It's called a 'Phase 2 theranostic trial,' which means it's an early step in testing a new treatment and using special tests to see if it's working. The drug being investigated is thiethylperazine. Researchers want to find out if this medicine can help slow down or change the way Alzheimer's disease affects the brain.

To do this, participants will be divided into two groups. One group will receive the actual medicine (thiethylperazine), and the other group will receive a 'placebo,' which looks like the medicine but doesn't contain any active drug. This comparison helps researchers understand if the changes they see are truly due to the medicine or just what happens naturally. They will use special brain scans (called Florbetaben-PET scans) at the start and after 12 months to measure changes in the brain related to Alzheimer's.

The study also includes various other tests to get a full picture. This involves blood tests to look for specific 'biomarkers' (substances in the blood that can give clues about the disease), as well as memory and thinking tests, and questionnaires about daily activities and quality of life. The aim is to see if the medicine has a positive effect on any of these measures over a year. There are also smaller tablet ingredients listed, like lactose and corn starch, which are common inactive ingredients used to make up the tablet.

Key takeaways

Tests a new drug (thiethylperazine) for early Alzheimer's.
Compares the drug to a placebo (dummy pill).
Uses special brain scans and blood tests to track changes.
Assesses memory, thinking, and quality of life.
Participation involves clinic visits over 12 months.
Aims to find new ways to treat Alzheimer's disease.

Who may be eligible?

This study is looking for adults who have recently been diagnosed with early Alzheimer's disease. There's no upper age limit, meaning people of all adult ages can potentially take part.

Both men and women are welcome to participate in this research. The most important factor for joining is having that recent diagnosis of early or mild Alzheimer's disease.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you an adult aged 18 or over?
Have you recently been diagnosed with early-stage Alzheimer's disease?
Are you able to attend regular clinic visits for 12 months?
Are you willing to have brain scans and blood tests?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be assigned to one of two groups: one receiving the study medicine (thiethylperazine) or one receiving a placebo (a tablet with no active drug). You won't know which group you're in. Participation involves regular visits to the clinic over a period of 12 months. These visits will include taking your study tablets (either thiethylperazine or placebo).

Key assessments will include special brain scans called Florbetaben-PET scans, which will be done at the beginning of the study and again after 12 months. You will also have blood tests at various points to check for specific markers. Additionally, you will regularly complete tests of your memory and thinking skills, as well as questionnaires about your daily life, mood, and overall well-being. The total duration of active participation is 12 months.

Potential risks and benefits

Participating in a study like this might offer potential benefits, such as contributing valuable knowledge to Alzheimer's research and potentially receiving a new treatment that isn't widely available. However, there's no guarantee of personal benefit, and you might receive a placebo. Potential risks are associated with the study medicine, such as side effects, or with the tests, like the small amount of radiation from brain scans or discomfort from blood draws. You will be closely monitored for any issues. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany

Common questions

What is Alzheimer's disease?

Alzheimer's disease is a condition that affects the brain, causing problems with memory, thinking, and daily activities. It usually gets worse over time.

What is thiethylperazine?

Thiethylperazine is a medicine being tested to see if it can help with early Alzheimer's. It's not a standard Alzheimer's treatment, which is why it's in a trial.

What is a placebo?

A placebo is a 'dummy' pill that looks just like the real medicine but contains no active drug. It helps researchers know if the medicine is actually working.

What is a Florbetaben-PET scan?

It's a special brain scan that can show changes in the brain linked to Alzheimer's disease, helping doctors track how the condition might be progressing.

Will I know if I'm getting the actual medicine?

No, in this type of study, participants usually don't know whether they are receiving the active medicine or the placebo until after the study has finished. This helps ensure fair results.