A Study Testing ACP-204 Tartrate Compared to Placebo for Adults with Lewy Body Dementia Psychosis

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What is this study about?

This study is looking at Lewy Body Dementia Psychosis, a condition where people with a type of dementia called Lewy body dementia experience hallucinations or false beliefs. Lewy body dementia is a brain disorder that affects thinking, movement, and behavior, and when it includes seeing or hearing things that are not there or having unusual beliefs, it is called Lewy Body Dementia Psychosis. The study will test a medication called ACP-204 in capsule form, which will be given by mouth. Some participants will receive placebo instead of the actual medication. The purpose of this study is to find out if ACP-204 works to reduce the symptoms of hallucinations and false beliefs in people with this condition, and to compare two different doses of the medication to see which one works better.

During the study, participants will take either ACP-204 at a dose of 30 milligrams daily, ACP-204 at a dose of 60 milligrams daily, or placebo for a period of six weeks. The main goal is to see if there is an improvement in symptoms related to hallucinations and false beliefs by measuring changes using a special rating scale designed for people with Lewy Body Dementia Psychosis. This scale looks at specific symptoms like seeing things that are not really there or having beliefs that do not match reality.

The study is designed to be double-blind, which means that neither the participants nor the doctors will know who is receiving the actual medication and who is receiving placebo during the treatment period. The treatment will last for six weeks, and doctors will check how well the medication works by comparing the symptoms at the beginning of the study to the symptoms at the end of the six-week period. This research is intended to help understand whether ACP-204 can be a helpful treatment option for adults living with Lewy Body Dementia Psychosis.

1 Treatment period begins

Upon joining the study, you will be assigned to one of three treatment groups. This assignment will be done randomly, similar to flipping a coin.

You may receive either ACP-204 30 mg capsules, ACP-204 60 mg capsules, or placebo capsules. A placebo is a capsule that looks identical to the active treatment but contains no active medicine.

Neither you nor the study doctor will know which treatment you are receiving. This is called a double-blind design and helps ensure accurate results.

All capsules are taken by mouth.

2 Daily medication administration

You will take your assigned capsules daily throughout the treatment period.

The exact dosing schedule and frequency will be provided by the study staff based on your assigned group.

It is important to take the capsules as instructed each day.

3 Assessment at baseline

At the beginning of the treatment period, your symptoms will be evaluated using a specific assessment tool.

This assessment focuses on symptoms such as hallucinations (seeing or hearing things that are not there) and delusions (false beliefs).

The assessment is called the Scale for the Assessment of Positive Symptoms for Lewy Body Dementia Psychosis, which contains 9 questions.

This baseline measurement will be used to compare any changes in your symptoms during the study.

4 Week 6 assessment

After 6 weeks of taking the study medication, you will undergo the same symptom assessment again.

The study staff will measure any changes in your symptoms compared to the baseline assessment.

This is the main time point for evaluating whether the treatment has had an effect on your symptoms.

5 Completion of treatment period

After the Week 6 assessment, the main treatment period of the study will be complete.

Additional follow-up visits or assessments may be scheduled as part of the study procedures.

The study staff will provide instructions regarding any further steps or the end of your participation.

Who Can Join the Study?

  • You must be 55 years of age or older but younger than 85 years at the time of the screening visit
  • You can be male or female
  • You must be living in the community at home or in a care facility if allowed by local rules
  • You must be able to provide written informed consent, which means you agree in writing to take part in the study after understanding what it involves. If you are not able to provide consent yourself, a legally authorized representative (someone legally allowed to make decisions for you) or your study partner or caregiver must provide written consent on your behalf, and you must provide written agreement if you are able to do so
  • You must meet the medical criteria for Parkinson’s disease with dementia, which is a condition where Parkinson’s disease leads to problems with memory and thinking, or you must meet the criteria for probable dementia with Lewy bodies, which is a type of dementia caused by abnormal protein deposits in the brain
  • You must meet the criteria for psychosis, which means experiencing things that are not real such as seeing or hearing things that others do not, or having false beliefs, and these symptoms must be related to your memory and thinking problems

Who Cannot Join the Study?

  • The study does not list specific exclusion criteria in the provided information, meaning details about who cannot participate are not available in this data
  • Generally, clinical trials may exclude patients based on other medical conditions, medications they are taking, or safety concerns, but these specific details are not provided here
  • If you are interested in this study, the research team would need to provide the complete list of reasons why someone might not be able to participate

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Diagnostics-Consultancy Center Mladost M Varna OOD Varna Bulgaria
Neurohk s.r.o. Chocen Czechia
Azienda Ospedaliera Universitaria San Giovanni Di Dio E Ruggi d’Aragona Salerno Italy
Dr. Ivo Natsov Outpatient Clinic For Individual Practice For Specialized Medical Care In Psychiatry ET Cherven Bryag Bulgaria
Medical Center Saint Naum EOOD Sofia Bulgaria
Fakultni Nemocnice U Sv Anny V Brne Brno-Stred Czechia
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
Pia Fondazione Di Culto E Religione Card G Panico Tricase Italy
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Universita’ Campus Bio-medico Di Roma Rome Italy
Vestra Clinics s.r.o. Rychnov Nad Kneznou Czechia
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Universita Degli Studi Di Brescia Brescia Italy
Neuropsychiatrie s.r.o. Prague Czechia
Diagnostic And Consultation Centre St.Vrach And St.St. Kuzma And Damian OOD Sofia Bulgaria
Ceydpu Hxsbqmkqcye Ridwdkvt Umgyxueoqpkmh De Ttlov Tours France
Cvcy Dm Nromw Vandoeuvre Les Nancy France
Ukapuyygcr Doifw Srqlo Dm Rtfa Ls Sxastnyf Rome Italy
Huffsqzg Ulhbpnenqquwxn Sprtrazvhe &pfmnpa Hpgvget dg Hmhpmkownwn STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Recruiting
28.11.2025
Czechia Czechia
Recruiting
28.11.2025
France France
Recruiting
28.11.2025
Italy Italy
Recruiting
28.11.2025

Trial locations

Investigated drugs:

ACP-204 is an investigational medication being studied for the treatment of psychosis in people with Lewy body dementia. Psychosis can include symptoms like hallucinations (seeing or hearing things that are not there) and delusions (false beliefs). This medication is being tested to see if it can help reduce these symptoms in patients with this type of dementia.

Placebo is an inactive substance that looks like the real medication but contains no active drug. It is used in this study to compare against the actual medication to determine if the medication truly works. Some participants will receive the placebo instead of the active medication.

Investigated diseases:

Lewy Body Dementia – Lewy Body Dementia is a brain disorder that occurs when abnormal protein deposits called Lewy bodies build up in nerve cells in the brain. These deposits affect chemicals in the brain and lead to problems with thinking, movement, behavior, and mood. People with this condition experience changes in their ability to think clearly and pay attention, which can vary significantly from day to day or even hour to hour. Visual hallucinations, where people see things that are not there, are common and occur early in the disease. Movement problems similar to Parkinson’s disease often develop, including slow movement, stiff muscles, and trembling. The condition progresses over time, gradually affecting more areas of brain function and daily activities.

Trial ID:
2025-521710-25-00
Protocol code:
ACP-204
NCT ID:
NCT07029581
Trial Phase:
Therapeutic exploratory (Phase II)

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