Tests ACP-204 for psychosis in Lewy body dementia
Tests ACP-204 against a placebo in adults with Lewy body dementia psychosis.
Plain-language title generated from the registry record
Registry title: Phase 2, Efficacy and Safety Study of ACP-204 in Lewy Body Dementia Psychosis
Key facts
- Where
- Brescia, Naples, Rome, Salerno, and Tricase, ItalySee the 6 sites
- Phase
- Phase 2
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: NCT07029581, who can take part
Where in Italy
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaBrescia, ItalyTaking people
- Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi VanvitelliNaples, ItalyTaking people
- Azienda Ospedaliero-Universitaria Policlinico Umberto IRome, ItalyTaking people
- Università Campus Bio-Medico di RomaRome, ItalyTaking people
- Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'AragonaSalerno, ItalyTaking people
- Pia Fondazione Di Culto E Religione Card G PanicoTricase, ItalyTaking 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
- NCT07029581EU 2025-521710-25-00
- Record updated
- 4 November 2026
- Original description
Multicenter, randomized, 6-week, double-blind, placebo-controlled, parallel-group, Phase 2 study in subjects with LBDP.Read full original descriptionShow less
A Double-Blind, Placebo-Controlled, Phase 2, Efficacy and Safety Study of ACP-204 in Adults With Lewy Body Dementia Psychosis (LBDP)
Multicenter, randomized, 6-week, double-blind, placebo-controlled, parallel-group, Phase 2 study in subjects with LBDP.
Inclusion: Male or female ≥55 years to <85 years of age at the Screening visit living in the community or, if permitted by local regulations, in an institutionalized setting; Can 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 must provide written informed consent; The subject must provide written (if capable) informed assent per local regulations; Meets either the clinical criteria for Parkinson's disease with dementia as defined by the Movement Disorder Society's Task Force or the revised clinical criteria for probable dementia with Lewy bodies (DLB) by consensus criteria (Fourth consensus report of the DLB Consortium); Meets the revised criteria for psychosis in major or mild neurocognitive disorder established by the International Psychogeriatrics Association.
Exclusion: Is in hospice, is receiving end-of-life palliative care, or is bedridden; Has psychotic symptoms that are primarily attributable to delirium, substance abuse, or a medical or psychiatric condition (e.g. schizophrenia, bipolar disorder, delusional disorder) other than dementia; Has a history or current evidence of a serious and/or significant unstable cardiovascular, respiratory, endocrine, gastrointestinal, renal, hepatic, hematologic, immunologic, genitourinary, psychiatric or neurologic (including stroke, chronic seizures, or clinically significant head injury) abnormality or disease or other medical disorder, including cancer or malignancies that could interfere with subject's ability to complete the study or comply with study procedures; Has other clinically significant CNS abnormalities that are most likely contributing to the dementia or findings on MRI or CT; Is actively suicidal at Visit 1 (Screening) or Visit 2 (Baseline).