A Study of ACP-204 Tartrate 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 Lewy body dementia experience symptoms such as seeing or hearing things that are not there or having false beliefs. Lewy body dementia is a brain disorder that affects thinking, movement, behavior, and mood. The treatment being tested is ACP-204, which is given as a capsule taken by mouth. This medication is being studied to see if it can help manage the symptoms of psychosis in people with this type of dementia.

The purpose of this study is to evaluate the safety and tolerability of long-term treatment with ACP-204 in people with Lewy body dementia psychosis. This study will last for 52 weeks, which is about one year. During this time, all participants will receive the study medication, and there will be different dose levels that may be given. The study is designed for adults who have already completed a previous study with ACP-204 and who may benefit from continuing to take this medication. Participants will need to attend study visits together with a caregiver or study partner who knows them well and can provide information about their condition.

Throughout the study, doctors will monitor participants regularly to check for any side effects or unwanted reactions to the medication. The study will collect information about any health problems that occur during treatment. Participants will continue to take the medication for the full year unless their doctor decides it is not safe or appropriate to continue. The study aims to understand how well people tolerate this medication when taken over a longer period of time compared to shorter studies.

1 Enrollment and baseline assessment

This study begins immediately after completing the previous ACP-204-012 study. You will transition directly from that study into this extension study.

You must have completed Visit 6 (end of treatment) of the previous study without stopping early to be eligible for this extension study.

You will need to attend all study visits with your study partner or caregiver present throughout the entire study.

If you are female, you must not be able to become pregnant. If you are male, you must agree to use a condom during sexual intercourse and your female partner must use additional birth control if she can become pregnant. These precautions must continue for at least 90 days after your last dose of the study medication. Males must also refrain from donating sperm during this time.

2 Treatment with ACP-204

You will receive ACP-204 tartrate in capsule form to take by mouth.

This is an open-label study, which means both you and your doctor will know you are receiving the active medication.

The treatment will continue for 52 weeks (approximately one year).

Your doctor will determine the specific dosage and frequency of the capsules based on what may benefit you most.

The medication is designed to treat psychosis symptoms associated with Lewy body dementia, which is a condition affecting the brain that can cause hallucinations and other changes in thinking and perception.

3 Regular monitoring visits

Throughout the 52-week treatment period, you will attend scheduled study visits at the study site.

During these visits, the study team will monitor your safety and how well you tolerate the medication.

Your study partner or caregiver must accompany you to each visit.

The study team will assess any side effects or health changes you experience, known as treatment-emergent adverse events.

4 End of treatment

After completing the 52-week treatment period, you will have a final assessment.

The study is expected to continue enrolling participants until December 2025 and will conclude by February 2028.

All information collected during the study will be used to evaluate the long-term safety of ACP-204 for treating psychosis in people with Lewy body dementia.

Who Can Join the Study?

You must have completed the previous study called ACP-204-012 through the end of treatment visit without stopping early
Your doctor believes that you may benefit from long-term treatment with the study medication ACP-204
You must be able to attend all study visits with a study partner or caregiver, which is someone who knows you well and can accompany you to appointments
You must be able to understand what the study involves and sign a consent form agreeing to participate, or if you are not able to make this decision yourself, a legally authorized representative (someone legally allowed to make decisions on your behalf) must sign the consent form and you must agree to participate
If you are a woman, you must not be able to become pregnant, meaning you have gone through menopause (the natural end of monthly periods) or have had surgery that prevents pregnancy
If you are a man, you must agree not to donate sperm during the study and for at least 90 days after your last dose of study medication
If you are a man who is sexually active with a woman who could become pregnant, you must either avoid sexual intercourse completely during the study and for 90 days after, or use a condom and your female partner must also use a reliable birth control method

Who Cannot Join the Study?

The source data does not provide specific exclusion criteria, which are reasons why a patient cannot participate in the study
Without detailed information about who cannot join this clinical trial, it is not possible to list the specific conditions or situations that would prevent participation
Generally, clinical trials have rules about who can and cannot participate, but these specific details are not available in the provided information

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli	Naples	Italy
Children’s Health Medical Center EOOD	Sofia	Bulgaria
Centre Hospitalier Universitaire De Lille	Lille	France
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
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
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
Fakultni Nemocnice U Sv Anny V Brne	Brno-Stred	Czechia
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
Cmjali Hbsokkqotnm Rrmwstfl Uqtrazadjrlbn Dh Tgxlm	Tours	France
Ccyw Db Nifub	Vandoeuvre Les Nancy	France
Uplvjceczg Dypsy Skkna Di Rkij Lc Spkzfiyn	Rome	Italy
Hwvangbg Ugbpouxmsovfou Smotvccvap &tphgwq Hvhwdib da Hgyjkunuqrd	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
Bulgaria	Recruiting	01.12.2025
Czechia	Not yet recruiting	01.12.2025
France	Not yet recruiting	01.12.2025
Italy	Not yet recruiting	01.12.2025

Trial locations

Investigated drugs:

Acp-204 Tartrate

ACP-204 is an investigational medication being studied for the treatment of psychosis in adults with Lewy body dementia. This medication is being tested to see if it is safe and well-tolerated when taken over a long period of time. The study is looking at how this medication works in patients who experience hallucinations, delusions, or other psychotic symptoms related to their Lewy body dementia.

Investigated diseases:

Dementia with Lewy bodies

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. This condition affects thinking abilities, memory, and movement control. People with this disease often experience changes in attention and alertness that can vary throughout the day. Visual hallucinations, where people see things that are not really there, are common in this condition. The disease also causes problems with movement similar to Parkinson’s disease, including slow movements, stiff muscles, and tremors. As the condition progresses, it becomes increasingly difficult for affected individuals to perform daily activities and maintain independence.

Trial ID:

2025-521711-39-00

Protocol code:

ACP-204-013

Trial Phase:

Therapeutic confirmatory (Phase III)

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A Study of ACP-204 Tartrate for Adults With Lewy Body Dementia Psychosis

What is this study about?

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