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

NCT07029581 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: ACP-204-0122025-521710-25-00
• Study Type: interventional
• Target: 180
• Locations: 6 countries
• Sites: 54

Brief Summary

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

Conditions

Lewy Body Dementia Psychosis

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in SAPS-LBDP total score at Week 6

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

  6 weeks

Study Arms (3)

ACP-204 30 mg

EXPERIMENTAL

ACP-204 dose of 30 mg once daily

Drug: ACP-204

ACP-204 60 mg

EXPERIMENTAL

ACP-204 dose of 60 mg once daily

Drug: ACP-204

Placebo

PLACEBO COMPARATOR

Placebo once daily

Drug: Placebo

Interventions

ACP-204 DRUG

Provided as 1 capsule, to be taken orally once daily

ACP-204 30 mg; ACP-204 60 mg

Placebo DRUG

Provided as 1 capsule, to be taken orally once daily

Placebo

Eligibility Criteria

• Age: 55 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ACADIA Pharmaceuticals Inc.: lead

Study Sites (54)

ATP Clinical Research Inc.

Irvine, California, 92612, United States

RECRUITING

Georgetown University

Washington D.C., District of Columbia, 20057, United States

RECRUITING

Humanity Clinical Research, Corp

Aventura, Florida, 33180, United States

RECRUITING

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, 33486, United States

RECRUITING

K2 Medical Research Winter Garden LLC

Clermont, Florida, 34711, United States

RECRUITING

University of Florida - Shands

Gainesville, Florida, 32608, United States

RECRUITING

K2 Summit Research

Lady Lake, Florida, 32159, United States

RECRUITING

Neurology Associates, P. A.

Maitland, Florida, 32751, United States

RECRUITING

Homestead Associates in Research Inc

Miami, Florida, 33032, United States

RECRUITING

Premier Clinical Research Institute, Inc.

Miami, Florida, 33122, United States

RECRUITING

Advanced Clinical Research Network, Corp

Miami, Florida, 33135, United States

RECRUITING

MediClear Medical & Research Center, Inc.

Miami, Florida, 33165, United States

RECRUITING

Health Synergy Clinical Research, LLC

West Palm Beach, Florida, 33407, United States

RECRUITING

Hawaii Pacific Neuroscience

Honolulu, Hawaii, 96817, United States

RECRUITING

University of Kansas Medical Center Research Institute Inc.

Kansas City, Kansas, 66160, 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, 11725, United States

RECRUITING

UNC Hospitals

Chapel Hill, North Carolina, 27517, United States

RECRUITING

The Ohio State University, Energy Advancement and Innovation Center

Columbus, Ohio, 43210, United States

RECRUITING

The Movement Disorder Clinic of Oklahoma

Tulsa, Oklahoma, 74136, United States

RECRUITING

Abington Neurological Associates, LTD

Abington, Pennsylvania, 19001, United States

SUSPENDED

Horizon Clinical Research Group

Cypress, Texas, 77429, United States

RECRUITING

The University of Texas Health Science Center San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

R and H Clinical Research

Stafford, Texas, 77477, United States

RECRUITING

Virginia Commonwealth University (a public institution of higher education)

Richmond, Virginia, 23219, United States

RECRUITING

EvergreenHealth

Kirkland, Washington, 98034, United States

RECRUITING

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

Cherven Bryag, 5980, Bulgaria

RECRUITING

UMHAT Sv Georgi EAD

Plovdiv, 4002, Bulgaria

RECRUITING

Medical Center SV.Naum

Sofia, 1113, Bulgaria

RECRUITING

UMHAT "Alexandrovska" EAD

Sofia, 1431, Bulgaria

RECRUITING

Medical Center Detsko Zdrave Branch Maestro Kanev

Sofia, 1618, Bulgaria

RECRUITING

DCC Mladost M- Varna, OOD

Varna, 9000, Bulgaria

RECRUITING

Fakultni nemocnice u sv. Anny v Brne

Brno, 656 91, Czechia

RECRUITING

NEUROHK s.r.o. Poliklinika Chocen a.s.

Choceň, 56501, Czechia

RECRUITING

Vseobecna fakultni nemocnice v Praze

Prague, 12808, Czechia

RECRUITING

Neuropsychiatrie s.r.o.

Prague, 16000, Czechia

RECRUITING

Vestra Clinics s.r.o

Rychnov nad Kněžnou, 51601, Czechia

RECRUITING

CHU de Toulouse- Hopital Purpan

Toulouse, Cedex 9, 31059, France

RECRUITING

Gérontopôle Centre de Recherche Clinique

Toulouse, Cedex 9, 31059, France

RECRUITING

Hopital Roger Salengro - CHU Lille

Lille, Nord, 59037, France

RECRUITING

Hôpital Lariboisière, Histologie et CMRR

Paris, Paris, 75010, France

RECRUITING

Hôpital des Chapennes

Villeurbanne, Rhone, 69100, France

RECRUITING

Hopital Neurologique Bron

Bron, 69677, France

RECRUITING

Hopital BROCA

Paris, 75013, France

RECRUITING

CHU Strasbourg-Hopital Hautepierre

Strasbourg, 67000, France

RECRUITING

CHRU de Tours- Hopital Bretonneau

Tours, 37044, France

RECRUITING

CHRU de Nancy- Hospital de Brabois

Vandœuvre-lès-Nancy, 54511, France

RECRUITING

Azienda Ospedaliera Univerrsitaria

Naples, Napoli, 80138, Italy

RECRUITING

Azieda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Brescia, 25123, Italy

RECRUITING

Università Campus Bio-Medico di Roma

Roma, 128, Italy

RECRUITING

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

Roma, 185, Italy

RECRUITING

Institute of Mental Health

Belgrade, 11000, Serbia

RECRUITING

University Clinical Center of Serbia

Belgrade, 11000, Serbia

RECRUITING

University Clinical Hospital Center Zvezdara

Belgrade, 11000, Serbia

RECRUITING

University Clinical Center Kragujevac

Kragujevac, 34000, Serbia

RECRUITING

Central Study Contacts

Kristin Kidd

CONTACT

434-841-3162; Kristin.kidd@acadia-pharm.com

Becky Howell

CONTACT

848-702-1886; bhowell@acadia-pharm.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized to one of 3 parallel arms i.e. ACP-204 at one of 2 dose levels (30 or 60 mg) or placebo

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 19, 2025
• Study Start: August 6, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: April 22, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

BU (6); US (25); FR (10); IT (4); SE (4); CZ (5)