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ACP-204 in Adults With Lewy Body Dementia Psychosis (LBDP)
EU CTIS ID: 2025-521711-39-00
What this study is testing
To evaluate the safety and tolerability of long-term ACP-204 treatment in subjects with LBDP
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- The subject may benefit from long-term therapy with open-label ACP-204 treatment in the judgment of the Investigator
- Subject has completed Visit 6 (EOT) of the antecedent ACP-204-012 study and did not have an early discontinuation from the antecedent study
- Can complete all study visits with a study partner/caregiver
- Can understand the nature of the study and protocol requirements and provide written informed consent. If the subject is deemed not competent to provide informed consent, the following requirements for consent must be met: a. The subject’s LAR (or study partner/caregiver, if local regulations allow) must provide written informed consent. b. The subject must provide written (if capable) informed assent per local regulations.
- If the subject is a female, she must be of nonchildbearing potential
- If the subject is male, he must agree to the following during the study intervention period and for at least 90 days after the last dose of study drug: a. Refrain from donating sperm, AND b. Either be abstinent from sexual intercourse where pregnancy can occur (abstinent on a long-term and persistent basis) and agree to remain abstinent OR Use a condom and subject's female partner (if of childbearing potential and not pregnant) must use an additional contraceptive method
You likely can't join if
- Is judged by the Investigator or the Medical Monitor to be inappropriate for the study for any reason
- Is in hospice, is receiving end-of-life palliative care, or is bedridden
- Has a heart rate <50 beats per minute, as measured by vital signs at Baseline (EOT visit of the antecedent study). If bradycardia is secondary to iatrogenic or treatable causes and these causes are addressed, a heart rate assessment can be repeated.
- Has a BMI <18.5 kg/m or known unintentional weight loss ≥7% of body weight over past 6 months
- Has a clinically significant laboratory abnormality in the antecedent ACP-204-012 study, excepting at ACP-204-012 EOT, that in the judgment of the Investigator or Medical Monitor, will either: a. jeopardize the safe participation of the subject in this study; OR b. interfere with the conduct or interpretation of safety or efficacy evaluations in the study
- Is actively suicidal at Visit 1 (Baseline, EOT visit of the antecedent study)
See the full eligibility criteria
Who can join
- The subject may benefit from long-term therapy with open-label ACP-204 treatment in the judgment of the Investigator
- Subject has completed Visit 6 (EOT) of the antecedent ACP-204-012 study and did not have an early discontinuation from the antecedent study
- Can complete all study visits with a study partner/caregiver
- Can understand the nature of the study and protocol requirements and provide written informed consent. If the subject is deemed not competent to provide informed consent, the following requirements for consent must be met: a. The subject’s LAR (or study partner/caregiver, if local regulations allow) must provide written informed consent. b. The subject must provide written (if capable) informed assent per local regulations.
- If the subject is a female, she must be of nonchildbearing potential
- If the subject is male, he must agree to the following during the study intervention period and for at least 90 days after the last dose of study drug: a. Refrain from donating sperm, AND b. Either be abstinent from sexual intercourse where pregnancy can occur (abstinent on a long-term and persistent basis) and agree to remain abstinent OR Use a condom and subject's female partner (if of childbearing potential and not pregnant) must use an additional contraceptive method
What rules you out
- Is judged by the Investigator or the Medical Monitor to be inappropriate for the study for any reason
- Is in hospice, is receiving end-of-life palliative care, or is bedridden
- Has a heart rate <50 beats per minute, as measured by vital signs at Baseline (EOT visit of the antecedent study). If bradycardia is secondary to iatrogenic or treatable causes and these causes are addressed, a heart rate assessment can be repeated.
- Has a BMI <18.5 kg/m or known unintentional weight loss ≥7% of body weight over past 6 months
- Has a clinically significant laboratory abnormality in the antecedent ACP-204-012 study, excepting at ACP-204-012 EOT, that in the judgment of the Investigator or Medical Monitor, will either: a. jeopardize the safe participation of the subject in this study; OR b. interfere with the conduct or interpretation of safety or efficacy evaluations in the study
- Is actively suicidal at Visit 1 (Baseline, EOT visit of the antecedent study)
- Has a neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical or mental disorder, including cancer or malignancies that, in the judgment of the Investigator, would increase the risk associated with taking study medication or significantly interfere with the conduct or interpretation of the study
- Requires treatment with a medication or other substance that is prohibited by the protocol or will be used in a way that violates a use restriction
The study team makes the final eligibility decision.
Where it's taking place
- Serbia
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Serbia; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.