Tests ACP-204 for psychosis in people with Lewy body dementia
Tests ACP-204 long term in adults with Lewy body dementia psychosis.
Plain-language title generated from the registry record
Registry title: Phase 3, Open Label Extension Study of ACP-204 in Lewy Body Dementia Psychosis
Key facts
- Where
- Bron, Lille Cedex, Paris, Paris Cedex 10, Strasbourg, Toulouse, Toulouse Cedex 9, Tours Cedex 9, Vandoeuvre Les Nancy Cedex, and Villeurbanne, FranceSee the 10 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 55 and 84 years old?
Source: NCT07095465, who can take part
Where in France
- Hospices Civils de LyonBron, FranceTaking people
- Centre Hospitalier Universitaire De LilleLille Cedex, FranceTaking people
- Assistance Publique Hopitaux de ParisParis, FranceTaking people
- Assistance Publique Hopitaux De ParisParis Cedex 10, FranceTaking people
- Les Hopitaux Universitaires de StrasbourgStrasbourg, FranceTaking people
- Centre Hospitalier Universitaire de ToulouseToulouse, FranceTaking people
- Centre Hospitalier Universitaire De ToulouseToulouse Cedex 9, FranceTaking people
- Centre Hospitalier Regional Universitaire De ToursTours Cedex 9, FranceTaking people
- CHRU De NancyVandoeuvre Les Nancy Cedex, FranceTaking people
- Hospices Civils De LyonVilleurbanne, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- ACADIA Pharmaceuticals Inc.
- Trial code
- NCT07095465EU 2025-521711-39-00
- Record updated
- 4 November 2026
- Original description
A 52-Week, Phase 3, Open-Label Extension Study of ACP-204 in Adults With Lewy Body Dementia Psychosis (LBDP)Read full original descriptionShow less
52-Week, Phase 3, Open-Label Extension Study of ACP-204 in Adults With Lewy Body Dementia Psychosis (LBDP)
A 52-Week, Phase 3, Open-Label Extension Study of ACP-204 in Adults With Lewy Body Dementia Psychosis (LBDP)
Inclusion: 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:; The subject's LAR (or study partner/caregiver, if local regulations allow) must provide written informed consent; 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:; Refrain from donating sperm, AND; 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.
Exclusion: Is in hospice, is receiving end-of-life palliative care, or is bedridden; 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; 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 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; 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:; jeopardize the safe participation of the subject in this study; OR; interfere with the conduct or interpretation of safety or efficacy evaluations in the study; Is judged by the Investigator or the Medical Monitor to be inappropriate for the study for any reason; Has a BMI <18.5 kg/m2 or known unintentional weight loss ≥7% of body weight over past 6 months; Is actively suicidal at Visit 1 (Baseline, EOT visit of the antecedent study).