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NCT06159673PHASE2, PHASE3Recruiting

ACP-204 in Adults With Alzheimer's Disease Psychosis

ACADIA Pharmaceuticals Inc.

Start Date

11/14/2023

Completion Date

2/1/2028

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).

Eligibility Criteria

Age Range: 55 years to 95 years

Inclusion Criteria: * Is male or female and ≥55 and ≤95 years of age living in the community or in an institutionalized setting * Meets clinical criteria for possible or probable AD based on the 2011 National Institute on Aging-Alzheimer Association (NIA-AA) criteria * Meets the revised criteria for psychosis in major or mild neurocognitive disorder established by the International Psychogeriatrics Association (IPA) * Has either blood-based biomarker or documented evidence (e.g. positron emission tomography, cerebrospinal fluid biomarker) indicating amyloid plaque deposition and neuropathologic change consistent with AD * Has a prior magnetic resonance imaging or computed tomography scan of the brain that is consistent with the diagnosis of AD * Meets revised criteria for psychosis in major or mild neurocognitive disorder as per International Psychogeriatrics Association * MMSE score ≥6 and ≤24 * Psychotic symptoms for at least 2 months * Lives in a stable place of residence and there are no plans to change living arrangements * Has a designated study partner/caregiver * Able to complete all study visits with a study partner/caregiver * Must be on a stable dose of cholinesterase inhibitor or memantine, if applicable Exclusion Criteria: * Requires treatment with a medication prohibited by the protocol * Is in hospice and receiving end-of-life palliative care, or has become bedridden * Requires skilled nursing care * Psychotic symptoms that are primarily attributable to delirium, substance abuse, or a medical or psychiatric condition other than dementia * Known history of cerebral amyloid angiopathy, epilepsy, central nervous system neoplasm, or unexplained syncope * Atrial fibrillation * Symptomatic orthostatic hypotension * Protocol-defined exclusionary clinical laboratory findings * Treatment with anti-tau therapy or donanemab within 2 months prior to Screening Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met.

Interventions

DRUG

ACP-204

DRUG

Placebo

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Conditions

Alzheimer's Disease Psychosis

Locations

Chandler Clinical Trials

Chandler, Arizona 85224

United States

Clinical Endpoint LLC

Scottsdale, Arizona 85258

United States

Advanced Research Center, Inc.

Anaheim, California 92805

United States

ATP Clinical Research

Costa Mesa, California 92626

United States

Neuro-Pain Medical Center

Fresno, California 93710

United States

National Institute of Clinical Research

Garden Grove, California 92844

United States

Humanity Clinical Research Corp

Aventura, Florida 33180

United States

Arrow Clinical Trials

Daytona Beach, Florida 32117

United States

First Excellent Research Group

Doral, Florida 33178

United States

New Life Medical Research Center Inc.

Hialeah, Florida 33012

United States

Reliable Clinical Research LLC.

Hialeah, Florida 33012

United States

Homestead Associates in Research Inc.

Miami, Florida 33032

United States

Premier Clinical Research Institute, Inc.

Miami, Florida 33122

United States

Central Miami Medical Institute

Miami, Florida 33125

United States

Advanced Clinical Research Network, Corp

Miami, Florida 33135

United States

Verus Clinical Research

Miami, Florida 33135

United States

Future Care Solution, LLC

Miami, Florida 33165

United States

MediClear Medical & Research Center, Inc.

Miami, Florida 33165

United States

ABBA Medical Group LLC

Miami, Florida 33176

United States

Visionary Investigators Network

Miami, Florida 33176

United States

Quantum Clinical Trials

Miami Beach, Florida 33140

United States

New Med Research

Miami Gardens, Florida 33056

United States

Floridian Neuroscience Institutue

Miami Lakes, Florida 33016

United States

Combined Research Orlando Phase I IV

Orlando, Florida 32807

United States

Psych Me Medical Research Inc

Tampa, Florida 33614

United States

Neuroscience Research Institute

West Palm Beach, Florida 33407

United States

Revive Research Institute, Inc.

Elgin, Illinois 60123

United States

Grace Research, LLC

Shreveport, Louisiana 71105

United States

Khan Revive Research Institute

Rochester Hills, Michigan 48307

United States

Tekton Research, LLC

St Louis, Missouri 63128

United States

Alivation Research, LLC

Lincoln, Nebraska 68526

United States

Dent Neurologic Institute

Amherst, New York 14226

United States

Finger Lakes Clinical Research

Rochester, New York 14618

United States

Regional Neurological Associates

The Bronx, New York 10466

United States

Insight Clinical Trials LLC

Beachwood, Ohio 44122

United States

Valley Medical Research

Centerville, Ohio 45459

United States

Abington Neurological Associates

Abington, Pennsylvania 19001

United States

Horizon Clinical Research Group

Cypress, Texas 77429

United States

Prolato Clinical Research Center-Patton

Houston, Texas 77054

United States

University of Texas Health Science Center

Houston, Texas 77054

United States

Clinical Trial Network LLC

Houston, Texas 77074

United States

Kaleidoscope Clinical Research

Houston, Texas 77089

United States

Steven South Goldstein MD and Associates

Houston, Texas 77089

United States

World Research Link

Pasadena, Texas 77504

United States

R & H Clinical Research Inc.

Stafford, Texas 77477

United States

Tranquil Clinical Research

Webster, Texas 77598

United States

Clinica Neurologica e Neurocirurgica de Joinville

Joinville, Santa Catarina 89202-190

Brazil

L2IP - Instituto de Pesquisas Clínicas Ltda

Brasília, 70200-730

Brazil

Hospital Universitario de Brasilia

Brasília, 70840-901

Brazil

CECPAR Centro de Estudos Clinicos do Parana

Curitiba, 80030-310

Brazil

TrialTech Tecnologia com Pesquisas em Medicamentos

Curitiba, 80240-280

Brazil

Inst. de Neurologia de Curitiba Hospital Ecoville

Curitiba, 81210-310

Brazil

Instituto Mederi de Pesquisa e Saude

Passo Fundo, 99010-120

Brazil

Hospital Moinhos de Vento

Porto Alegre, 90035-001

Brazil

Nucleo de Pesquisa Clínica do Rio Grande do Sul

Porto Alegre, 90430-001

Brazil

Ruschel Medicina e Pesquisa Clínica

Rio de Janeiro, 22270-060

Brazil

Facili-Centro Integrado de Psiquiatria

São Bernardo do Campo, 09726-150

Brazil

BR Trials-Ensaios Clinicos e Consultoria

São Paulo, 01236-030

Brazil

Hospital Sao Paulo

São Paulo, 04024-002

Brazil

Santa Paula Hospital Clinical Research Center

São Paulo, 04550-000

Brazil

Hospital das Clínicas da Faculdade de Medicina USP

São Paulo, 05403-000

Brazil

ET Dr. Ivo Natsov - AIPSMC in Psychiatry

Cherven Bryag, 5980

Bulgaria

Medical Center Lifemed

Kardzhali, 6600

Bulgaria

DCC "Higia"

Pazardzhik, 4400

Bulgaria

Medical center Medconsult Pleven OOD

Pleven, 5800

Bulgaria

UMHAT Sv. Georgi EAD

Plovdiv, 4000

Bulgaria

Medical center Spectar-Plovdic EOOD

Plovdiv, 4004

Bulgaria

Mental Health Centre - Prof. N Shipkovenski EOOD

Sofia, 1377

Bulgaria

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

Sofia, 1408

Bulgaria

UMHAT "Alexandrovska" EAD

Sofia, 1431

Bulgaria

UMHAT Alexandrovska EAD

Sofia, 1431

Bulgaria

Medical Center Hera EOOD

Sofia, 1510

Bulgaria

Medical Center Intermediea

Sofia, 1680

Bulgaria

UMHAT Prof. Dr. St. Kirkovich AD

Stara Zagora, 6003

Bulgaria

Psicomed Estudios Medicos

Antofagasta, 1270244

Chile

Biomedica Research Group

Santiago, 7500710

Chile

Especialidades Medicas L y S

Santiago, 7560356

Chile

CIC de la Universidad Catolica CICUC

Santiago, 8330024

Chile

BRAIN-SOUL THERAPY s.r.o.

Kladno, Czech Republic 27201

Czechia

Ad71 S.R.O.

Prague, Czech Republic 109 00

Czechia

Fakultni nemocnice u sv. Anny v Brne

Brno, 656 91

Czechia

NEUROHK s.r.o

Choceň, 56501

Czechia

CLINTRIAL s.r.o.

Prague, 100 00

Czechia

FORBELI s.r.o.

Prague, 160 00

Czechia

INEP medical s.r.o

Prague, 186 00

Czechia

Vestra Clinics s.r.o.

Rychnov nad Kněžnou, 516 01

Czechia

Hopital Neurologique Bron

Bron, 69677

France

Centre pour Personnes Âgées

Colmar, 68000

France

Centre Memoire Ressources Recherche CMRR

Dijon, 21000

France

CHU de Limoges-Hopital Dupuytren

Limoges, 87042

France

Hospices Civils de Lyon HCL

Lyon, 69002

France

Hôpital Lariboisière

Paris, 75010

France

Hopital BROCA

Paris, 75013

France

CHU Rouen-Hospital Charles Nicolle

Rouen, 76031

France

Hopital Purpan

Toulouse, 31059

France

Hôpital La Grave

Toulouse, 31059

France

CHRU de Tours- Hopital Bretonneau

Tours, 37044

France

Hôpital de Brabois Adultes

Vandœuvre-lès-Nancy, 545000

France

ASST degli Spedali Civili di Brescia

Brescia, 25123

Italy

Neurologia-Fondazione Instituto G. Giglio

Cefalù, 90015

Italy

IRCCS Neuromed Istituto Neurologico Mediterraneo

Isernia, 86077

Italy

Ospedale San Raffaele

Milan, 20132

Italy

Fondazione Policlinico Uni Campus Bio-Medico di Roma

Roma, 00128

Italy

Policlinico Universitario Agostino Gemelli

Roma, 00168

Italy

AOU Policlinico Umberto I

Roma, 00185

Italy

Azienda Ospedaliera Universitaria OO. RR. S.

Salerno, 84131

Italy

Dipartimento di Neuroscienze Rita Levi Montalcini

Torino, 10126

Italy

Azienda Ospedaliera Card. G. Panico

Tricase, 73039

Italy

Iecsi S.C.

Monterrey, N.L 64310

Mexico

Hospital Universitario Dr. Jose Eleuterio Gonzalez

Monterrey, Nuevo León 64460

Mexico

Hospital Universitario Dr. Gonzalo Valdes Valdes

Coahuila, 25000

Mexico

Clinical Research Institute S.C

Estado de México, 54055

Mexico

B&B Investigaciones Medicas SC

Mazatlán, 82140

Mexico

Health Pharma Professional Research S.A. de C.V.

Mexico City, 03100

Mexico

Mexico Centre for Clinical Research S.A de C.V

Mexico City, 03100

Mexico

Centro Estudios Clínicos y Esp. Médicas SC CECEM

Nuevo León, 64620

Mexico

BIND Investigaciones S.C.

San Luis Potosí City, 78213

Mexico

Neurociencias Estudios Clinicos

Sinaloa, 80020

Mexico

Centro para el Des de la Med y de Asist Med Esp SC

Sinaloa, 80230

Mexico

Clinical Hosp Center Dr Dragisa Misovic Dedinje

Belgrade, 11000

Serbia

Clinical. Hospital Center Zvezdara

Belgrade, 11000

Serbia

Institute of Mental Health

Belgrade, 11000

Serbia

Special Hospital for Cerebrovascular Disease Sveti Sava

Belgrade, 11000

Serbia

University Clinic Centre of Serbia

Belgrade, 11000

Serbia

Special Hospital for Psychiatric Diseases

Gornja Toponica, 18202

Serbia

Spl. Hosp. for Psychiatric Diseases Kovin

Kovin, 26220

Serbia

Janjic University Clinical Center Kragujevac

Kragujevac, 34000

Serbia

Jovanovic University Clinical Centre of Kragujevac

Kragujevac, 34000

Serbia

University Clinical Center Kragujevac

Kragujevac, 34000

Serbia

University Clinical Center Nis

Niš, 18000

Serbia

Spl. Hosp. for Psychiatric Diseases Sveti Vracevi

Novi Kneževac, 23330

Serbia

Gen. Hosp. Dr Radivoj Simonovic

Sombor, 25000

Serbia

General Hospital Valjevo

Valjevo, 14000

Serbia

Gachon University Gil Medical Center

Incheon, 21565

South Korea

Inha University Hospital

Incheon, 22332

South Korea

Korea University Anam Hospital

Seoul, 02841

South Korea

Eunpyeong St. Mary's Hospital

Seoul, 03312

South Korea

Hanyang University Seoul Hospital

Seoul, 04763

South Korea

Konkuk University Medical Center

Seoul, 05030

South Korea

Samsung Medical Center

Seoul, 06351

South Korea

SMG-SNU Boramae Medical Center

Seoul, 07061

South Korea

Hospital Universitario Virgen Macarena

Seville, 41009

Spain

Hospital Provincial de Zamora

Zamora, 49021

Spain

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 80756

Taiwan

E-DA Hospital

Kaohsiung City,

Taiwan

Taipei Medical University-Shuang Ho Hospital

New Taipei City, 23561

Taiwan

National Cheng Kung University Hospital

Tainan, 704

Taiwan

National Taiwan University Hospital

Taipei, 10002

Taiwan