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RECRUITING
NCT06159673
PHASE2/PHASE3

ACP-204 in Adults With Alzheimer's Disease Psychosis

Sponsor: ACADIA Pharmaceuticals Inc.

View on ClinicalTrials.gov

Summary

This is a master protocol for 3 independent, seamlessly enrolling, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies in patients with ADP * Substudy 1 (Phase 2) will evaluate efficacy and dose response of ACP-204 30 and 60 mg vs placebo. This substudy will be initiated first. * Substudies 2A and 2B (both: Phase 3) will be confirmatory studies of either both doses (ACP-204 30 and 60 mg, respectively) or a single dose from Part 1 vs placebo. Substudies 2A and 2B will be performed independently of each other and will commence after enrollment of Part 1. All 3 substudies will be analyzed independently of each other. Each substudy individually will consist of a screening period (up to 49 days); a double-blind treatment period (6 weeks); a safety follow-up period (30 days) for patients not rolling over into an open-label extension study; and vital status follow-up (for patients who terminated their substudy early).

Official title: A Master Protocol for Three Independent, Seamlessly Enrolling, Double-blind, Placebo-controlled Efficacy and Safety Studies of ACP-204 in Adults With Alzheimer's Disease Psychosis

Key Details

Gender

All

Age Range

55 Years - 95 Years

Study Type

INTERVENTIONAL

Enrollment

1074

Start Date

2023-11-14

Completion Date

2028-02

Last Updated

2026-10-19

Healthy Volunteers

No

Interventions

DRUG

ACP-204

ACP-204 is a potent and selective antagonist/inverse agonist of 5-hydroxytryptamine (serotonin) receptor subtype 2A.

DRUG

Placebo

ACP-204 matching placebo

Locations (154)

Chandler Clinical Trials

Chandler, Arizona, United States

Clinical Endpoint LLC

Scottsdale, Arizona, United States

Advanced Research Center, Inc.

Anaheim, California, United States

ATP Clinical Research

Costa Mesa, California, United States

Neuro-Pain Medical Center

Fresno, California, United States

National Institute of Clinical Research

Garden Grove, California, United States

Havana Research Institute LLC

Pasadena, California, United States

Quantum Clinical Research, Inc.

Pasadena, California, United States

Humanity Clinical Research Corp

Aventura, Florida, United States

Arrow Clinical Trials

Daytona Beach, Florida, United States

First Excellent Research Group

Doral, Florida, United States

New Life Medical Research Center Inc.

Hialeah, Florida, United States

Reliable Clinical Research LLC.

Hialeah, Florida, United States

Homestead Associates in Research Inc.

Miami, Florida, United States

Premier Clinical Research Institute, Inc.

Miami, Florida, United States

Central Miami Medical Institute

Miami, Florida, United States

Advanced Clinical Research Network, Corp

Miami, Florida, United States

Verus Clinical Research

Miami, Florida, United States

Future Care Solution, LLC

Miami, Florida, United States

MediClear Medical & Research Center, Inc.

Miami, Florida, United States

ABBA Medical Group LLC

Miami, Florida, United States

Visionary Investigators Network

Miami, Florida, United States

Quantum Clinical Trials

Miami Beach, Florida, United States

New Med Research

Miami Gardens, Florida, United States

Floridian Neuroscience Institutue

Miami Lakes, Florida, United States

Combined Research Orlando Phase I IV

Orlando, Florida, United States

Psych Me Medical Research Inc

Tampa, Florida, United States

Neuroscience Research Institute

West Palm Beach, Florida, United States

Agile Clinical Research Trials LLC

Atlanta, Georgia, United States

Revive Research Institute, Inc.

Elgin, Illinois, United States

Grace Research, LLC

Shreveport, Louisiana, United States

CBH Health LLC, dba CenExcel Gaithersburg

Gaithersburg, Maryland, United States

Khan Revive Research Institute

Rochester Hills, Michigan, United States

Tekton Research, LLC

St Louis, Missouri, United States

Alivation Research, LLC

Lincoln, Nebraska, United States

Dent Neurologic Institute

Amherst, New York, United States

Finger Lakes Clinical Research

Rochester, New York, United States

SUNY Upstate Medical University

Syracuse, New York, United States

Regional Neurological Associates

The Bronx, New York, United States

Insight Clinical Trials LLC

Beachwood, Ohio, United States

Valley Medical Research

Centerville, Ohio, United States

NDx Clinical Research Inc.

Dayton, Ohio, United States

Abington Neurological Associates

Abington, Pennsylvania, United States

Horizon Clinical Research Group

Cypress, Texas, United States

Prolato Clinical Research Center-Patton

Houston, Texas, United States

University of Texas Health Science Center

Houston, Texas, United States

Clinical Trial Network LLC

Houston, Texas, United States

Kaleidoscope Clinical Research

Houston, Texas, United States

Steven South Goldstein MD and Associates

Houston, Texas, United States

World Research Link

Pasadena, Texas, United States

R & H Clinical Research Inc.

Stafford, Texas, United States

Tranquil Clinical Research

Webster, Texas, United States

Clinica Neurologica e Neurocirurgica de Joinville

Joinville, Santa Catarina, Brazil

L2IP - Instituto de Pesquisas Clínicas Ltda

Brasília, Brazil

Hospital Universitario de Brasilia

Brasília, Brazil

CECPAR Centro de Estudos Clinicos do Parana

Curitiba, Brazil

TrialTech Tecnologia com Pesquisas em Medicamentos

Curitiba, Brazil

Inst. de Neurologia de Curitiba Hospital Ecoville

Curitiba, Brazil

Instituto Mederi de Pesquisa e Saude

Passo Fundo, Brazil

Hospital Moinhos de Vento

Porto Alegre, Brazil

Nucleo de Pesquisa Clínica do Rio Grande do Sul

Porto Alegre, Brazil

Ruschel Medicina e Pesquisa Clínica

Rio de Janeiro, Brazil

Facili-Centro Integrado de Psiquiatria

São Bernardo do Campo, Brazil

BR Trials-Ensaios Clinicos e Consultoria

São Paulo, Brazil

Hospital Sao Paulo

São Paulo, Brazil

Santa Paula Hospital Clinical Research Center

São Paulo, Brazil

Hospital das Clínicas da Faculdade de Medicina USP

São Paulo, Brazil

ET Dr. Ivo Natsov - AIPSMC in Psychiatry

Cherven Bryag, Bulgaria

Medical Center Lifemed

Kardzhali, Bulgaria

DCC "Higia"

Pazardzhik, Bulgaria

Medical center Medconsult Pleven OOD

Pleven, Bulgaria

UMHAT Sv. Georgi EAD

Plovdiv, Bulgaria

Medical center Spectar-Plovdic EOOD

Plovdiv, Bulgaria

Mental Health Centre - Prof. N Shipkovenski EOOD

Sofia, Bulgaria

DCC St. Vrach and St. St. Kuzma and Damian OOD

Sofia, Bulgaria

UMHAT "Alexandrovska" EAD

Sofia, Bulgaria

UMHAT Alexandrovska EAD

Sofia, Bulgaria

Medical Center Hera EOOD

Sofia, Bulgaria

Medical Center Intermedica

Sofia, Bulgaria

UMHAT Prof. Dr. St. Kirkovich AD

Stara Zagora, Bulgaria

Psicomed Estudios Medicos

Antofagasta, Chile

Biomedica Research Group

Santiago, Chile

Especialidades Medicas L y S

Santiago, Chile

CIC de la Universidad Catolica CICUC

Santiago, Chile

BRAIN-SOUL THERAPY s.r.o.

Kladno, Czech Republic, Czechia

Ad71 S.R.O.

Prague, Czech Republic, Czechia

Fakultni nemocnice u sv. Anny v Brne

Brno, Czechia

NEUROHK s.r.o

Choceň, Czechia

CLINTRIAL s.r.o.

Prague, Czechia

FORBELI s.r.o.

Prague, Czechia

INEP medical s.r.o

Prague, Czechia

Vestra Clinics s.r.o.

Rychnov nad Kněžnou, Czechia

Hopital Neurologique Bron

Bron, France

Centre pour Personnes Âgées

Colmar, France

Centre Memoire Ressources Recherche CMRR

Dijon, France

CHU de Limoges-Hopital Dupuytren

Limoges, France

Hospices Civils de Lyon HCL

Lyon, France

Hôpital Lariboisière

Paris, France

Hopital BROCA

Paris, France

CHU Rouen-Hospital Charles Nicolle

Rouen, France

And 54 more locations on ClinicalTrials.gov