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Phase 2 Study of ACP-204 for Lewy Body Dementia Psychosis

This is a Phase 2 study testing a drug called ACP-204 for people with Lewy Body Dementia Psychosis. You would take one capsule of ACP-204 or a placebo (an inactive pill) once a day. The study is looking at how well ACP-204 works and if it's safe. We are looking for about 180 participants between 55 and 84 years old. To see if the treatment is successful, researchers will measure changes in psychosis symptoms using a scale called SAPS-LBDP after 6 weeks. The current recruitment status is unclear.

Study design
This is a Phase 2, randomized, double-blind study where participants will receive either ACP-204 or a placebo. It aims to enroll 180 participants.
What's involved
You would take one capsule daily for 6 weeks. The study measures changes in symptoms at the 6-week mark.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at 6 weeks after starting treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07029581

Phase 2, Efficacy and Safety Study of ACP-204 in Lewy Body Dementia Psychosis

Recruiting
PHASE2Ages 55–84InterventionalTreatment
ACADIA Pharmaceuticals Inc.
~180 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:ACP-204Placebo

At a glance

Recruiting sites
58 of 60 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from Baseline in SAPS-LBDP total score at Week 6
Measured over 6 weeks

Conditions

Lewy Body Dementia Psychosis

Explore related trials

Lewy Body Dementia

NCT07029581

Where you'd take part

This study runs at 60 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Advanced Clinical Research Network, Corp

    Miami, Floridano site contact published

    Recruiting

  • Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry - Dr Ivo Natsov

    Cherven Bryag, Bulgariano site contact published

    Recruiting

  • ATP Clinical Research Inc.

    Irvine, Californiano site contact published

    Recruiting

  • Azieda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

    Brescia, Italyno site contact published

    Recruiting

  • Azienda Ospedaliera Univerrsitaria

    Naples, Napoli, Italyno site contact published

    Recruiting

  • Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi D'Aragona

    Salerno, Salerno, Italyno site contact published

    Recruiting

  • Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza, UOI Day Hospital di Neurologia

    Roma, Italyno site contact published

    Recruiting

  • CHRU de Nancy- Hospital de Brabois

    Vandœuvre-lès-Nancy, Franceno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Kristin Kidd
[email protected]
434-841-3162
Email the study team

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Eligibility criteria

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:
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
Is actively suicidal at Visit 1 (Screening) or Visit 2 (Baseline)
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

What this trial measures

  • Change from Baseline in SAPS-LBDP total score at Week 66 weeks

    Change from Baseline in Scale for the Assessment of Positive Symptoms- Lewy Body Dementia Psychosis (SAPS-LBDP) total score at Week 6