NCT07029581From ClinicalTrials.govRecruiting

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

A Double-Blind, Placebo-Controlled, Phase 2, Efficacy and Safety Study of ACP-204 in Adults With Lewy Body Dementia Psychosis (LBDP)

Lewy Body Dementia Psychosis

At a glance

Phase: Phase 2
Study type: Interventional
Sponsor: ACADIA Pharmaceuticals Inc.
Enrolment target: 180
Started: 6 August 2025
Main results due: February 2028
Study sites: 61
Registry updated: 29 September 2026

Can you take part?

Ages 55 years to 84 years.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

Inclusion Criteria:

* 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:

  1. The subject's LAR must provide written informed consent.
  2. 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 Criteria:

* 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 study is about

In the sponsor’s own words, from the registry.

Multicenter, randomized, 6-week, double-blind, placebo-controlled, parallel-group, Phase 2 study in subjects with LBDP.

Study sites(61)

ATP Clinical Research Inc.
Irvine, California, United States
Recruiting
The University of Colorado
Aurora, Colorado, United States
Recruiting
Georgetown University
Washington D.C., District of Columbia, United States
Recruiting
Humanity Clinical Research, Corp
Aventura, Florida, United States
Recruiting
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States
Recruiting
K2 Medical Research Winter Garden LLC
Clermont, Florida, United States
Recruiting
University of Florida - Shands
Gainesville, Florida, United States
Recruiting
K2 Summit Research
Lady Lake, Florida, United States
Recruiting
Neurology Associates, P. A.
Maitland, Florida, United States
Terminated
Homestead Associates in Research Inc
Miami, Florida, United States
Recruiting
Premier Clinical Research Institute, Inc.
Miami, Florida, United States
Recruiting
Advanced Clinical Research Network, Corp
Miami, Florida, United States
Recruiting
Verus Clinical Research
Miami, Florida, United States
Recruiting
MediClear Medical & Research Center, Inc.
Miami, Florida, United States
Recruiting
Health Synergy Clinical Research, LLC
West Palm Beach, Florida, United States
Recruiting
Hawaii Pacific Neuroscience
Honolulu, Hawaii, United States
Recruiting
Rush University Medical Center
Chicago, Illinois, United States
Recruiting
University of Kansas Medical Center Research Institute Inc.
Kansas City, Kansas, United States
Recruiting
Parkinson's Disease and Movement Disorders Center of Boca Raton d/b/a Parkinson's Research Center of America-Long Island
Commack, New York, United States
Recruiting
UNC Hospitals
Chapel Hill, North Carolina, United States
Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Recruiting
The Ohio State University, Energy Advancement and Innovation Center
Columbus, Ohio, United States
Recruiting
The Movement Disorder Clinic of Oklahoma
Tulsa, Oklahoma, United States
Recruiting
Abington Neurological Associates, LTD
Abington, Pennsylvania, United States
Withdrawn
Horizon Clinical Research Group
Cypress, Texas, United States
Recruiting
Prolato Clinical Research Center
Houston, Texas, United States
Recruiting
The University of Texas Health Science Center San Antonio
San Antonio, Texas, United States
Recruiting
R and H Clinical Research
Stafford, Texas, United States
Recruiting
Virginia Commonwealth University (a public institution of higher education)
Richmond, Virginia, United States
Recruiting
EvergreenHealth
Kirkland, Washington, United States
Recruiting
Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry - Dr Ivo Natsov
Cherven Bryag, Bulgaria
Recruiting
UMHAT Sv Georgi EAD
Plovdiv, Bulgaria
Recruiting
Medical Center SV.Naum
Sofia, Bulgaria
Recruiting
DCC "Sv. Vrach and Sv. Sv. Kuzma and Damyan", OOD
Sofia, Bulgaria
Recruiting
UMHAT "Alexandrovska" EAD
Sofia, Bulgaria
Recruiting
Medical Center Detsko Zdrave Branch Maestro Kanev
Sofia, Bulgaria
Withdrawn
DCC Mladost M- Varna, OOD
Varna, Bulgaria
Recruiting
Fakultni nemocnice u sv. Anny v Brne
Brno, Czechia
Recruiting
NEUROHK s.r.o. Poliklinika Chocen a.s.
Choceň, Czechia
Recruiting
Vseobecna fakultni nemocnice v Praze
Prague, Czechia
Recruiting
Neuropsychiatrie s.r.o.
Prague, Czechia
Recruiting
Vestra Clinics s.r.o
Rychnov nad Kněžnou, Czechia
Recruiting
CHU de Toulouse- Hopital Purpan
Toulouse, Cedex 9, France
Recruiting
Gérontopôle Centre de Recherche Clinique
Toulouse, Cedex 9, France
Recruiting
Hopital Roger Salengro - CHU Lille
Lille, Nord, France
Recruiting
Hôpital Lariboisière, Histologie et CMRR
Paris, Paris, France
Recruiting
Hôpital des Chapennes
Villeurbanne, Rhone, France
Recruiting
Hopital Neurologique Bron
Bron, France
Recruiting
Hopital BROCA
Paris, France
Withdrawn
CHU Strasbourg-Hopital Hautepierre
Strasbourg, France
Recruiting
CHRU de Tours- Hopital Bretonneau
Tours, France
Recruiting
CHRU de Nancy- Hospital de Brabois
Vandœuvre-lès-Nancy, France
Recruiting
Azienda Ospedaliera Univerrsitaria
Naples, Napoli, Italy
Recruiting
Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi D'Aragona
Salerno, Salerno, Italy
Recruiting
Azieda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Brescia, Italy
Recruiting
Università Campus Bio-Medico di Roma
Roma, Italy
Recruiting
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza, UOI Day Hospital di Neurologia
Roma, Italy
Recruiting
Institute of Mental Health
Belgrade, Serbia
Recruiting
University Clinical Center of Serbia
Belgrade, Serbia
Recruiting
University Clinical Hospital Center Zvezdara
Belgrade, Serbia
Recruiting

Showing 60 of 61 sites — filter to narrow it down. 57 of the 61 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07029581. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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