Active not recruitingPHASE2INTERVENTIONAL

Study to Assess Safety and Efficacy of PRI-002 in Patients With MCI to Mild Dementia Due to Alzheimer's Disease (AD)

This study is looking into a new treatment called PRI-002 for people who have mild memory problems (Mild Cognitive Impairment) or early-stage Alzheimer's disease. Alzheimer's is caused by tiny, sticky clumps building up in the brain. Researchers believe PRI-002 might work by breaking up these clumps into harmless pieces. This could help reduce the impact of Alzheimer's on memory and thinking. The main goals of this study are to find out if PRI-002 is safe to use and if it actually helps people with these conditions. It's a key step in understanding if this new approach could become a future treatment option.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

PRInnovation GmbH

Enrolment target

304

Start

01 Dec 2023

Estimated completion

30 Jun 2026

Mild Cognitive Impairment Due to Alzheimer's Disease Alzheimer's Disease, Early Onset

What is this study about?

Alzheimer's disease is the most common form of memory loss, known as dementia. In the brains of people with Alzheimer's, certain small, sticky substances tend to clump together. These clumps are thought to cause damage, leading to the changes in memory, thinking, and behaviour that are typical of the disease.

Researchers are developing a new medicine, called PRI-002, to tackle these sticky clumps. They believe PRI-002 could work by breaking down these clumps into smaller, less harmful pieces. The hope is that by reducing these sticky substances, the new treatment could help lessen the effects of Alzheimer's disease.

This particular study is trying to find out two main things: first, if PRI-002 is safe for people to take, and second, if it actually helps those who have mild memory problems linked to Alzheimer's or early Alzheimer's disease itself. It's an important step in seeing if this new approach could lead to a helpful treatment for many people.

Key takeaways

This study is for people with early Alzheimer's or mild memory problems due to Alzheimer's.
It's testing a new drug, PRI-002, to see if it's safe and helps break down harmful brain clumps.
Participants will be between 55 and 80 years old and need a confirmed diagnosis of early Alzheimer's.
You will need a 'study companion' who helps you throughout your participation.
You might receive the active drug or a placebo (dummy drug).
Participation involves regular clinic visits for assessments and medication.

Who may be eligible?

This study is looking for volunteers between the ages of 55 and 80. You would need to have been diagnosed with mild memory problems (known as Mild Cognitive Impairment, or MCI) due to Alzheimer's, or mild Alzheimer's disease. Your doctor would have confirmed this diagnosis through special tests, such as a spinal fluid test or a brain scan to check for sticky substances related to Alzheimer's.

To be considered, your overall health would be checked to make sure you're a good fit for the study. For example, your body mass index (BMI) needs to be between 18.5 and 30, and you should be able to speak the local language well. You'd also need a reliable friend, family member, or carer (called a study companion) who can help you throughout the study and spend at least 6 hours a week with you.

Some things might mean you can't join. For instance, if your Alzheimer's disease is already advanced, or if you have other serious brain conditions, you wouldn't be able to take part. Women who could become pregnant would also not be able to participate, but men who are sexually active would need to agree to use contraception.

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 between 55 and 80 years old?
Have you been diagnosed with mild memory problems or mild Alzheimer's disease?
Do you have a reliable friend, family, or carer available to support you?
Are you generally in good health?
Are you able to attend regular clinic appointments?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to the clinic over a period of time. At these visits, you would have various assessments, which might include memory and thinking tests, and general health checks. You would be given either the study drug, PRI-002, or a placebo (a dummy drug with no active ingredients). This is to compare how people respond to the actual drug versus no active treatment.

Throughout the study, you would be carefully monitored by the study team. Both your wellbeing and any changes in your memory or thinking would be tracked. After you finish taking the study medication, there would be a follow-up period to make sure you're doing well and to collect any final important information. The total duration of your participation would be explained in full detail by the study team before you decide to join.

Potential risks and benefits

Participating in this study might offer some potential benefits, such as contributing to medical research that could one day help people with Alzheimer's, and receiving close medical monitoring during the trial. However, there are also potential risks, including possible side effects from the study medication, which the study team would explain in detail. You might also find the regular visits and tests tiring or stressful. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (38)

Neuro Health Centrum ltd.
Verified postcode
Brno, Czechia
NeuropsychiatrieHK, s.r.o.
Verified postcode
Hradec Králové, Czechia
A-Shine, s.r.o.
Verified postcode
Pilsen, Czechia
CLINTRIAL, s.r.o.
Verified postcode
Prague, Czechia
FORBELI s.r.o.
Verified postcode
Prague, Czechia
Neuropsychiatrie s.r.o.
Verified postcode
Prague, Czechia
INEP Medical s.r.o.
Verified postcode
Prague, Czechia
Uniklinik RWTH Aachen
Verified postcode
Aachen, Germany
Charité - Universitätsmedizin
Verified postcode
Berlin, Germany
Universitätsklinikum Düsseldorf
Verified postcode
Düsseldorf, Germany
Universitätsklinikum Magdeburg
Verified postcode
Magdeburg, Germany
ISPG - Institut für Studien zur Psychischen Gesundheit
Verified postcode
Mannheim, Germany

Common questions

What is Mild Cognitive Impairment (MCI)?

MCI means you have mild memory or thinking problems that are more than normal for your age, but not severe enough to be called dementia.

What is PRI-002 and how might it work?

PRI-002 is a new drug being tested. Researchers believe it can break down the sticky clumps in the brain that are thought to cause Alzheimer's disease.

Will I definitely get the active drug, PRI-002?

No, this study uses a 'placebo', so you might receive the active drug or a dummy drug. This helps researchers compare the effects fairly.

What does 'Phase 2' mean for this study?

Phase 2 means this is an early-stage study, focusing on whether the drug is safe and if it shows encouraging signs of working, after initial safety tests.

Do I need someone to come with me to appointments?

Yes, you would need a reliable friend, family member, or carer who can act as your 'study companion' and has frequent contact with you.