ACP-204 in Adults With Alzheimer's Disease Psychosis
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
Interventions
ACP-204
Placebo
Conditions
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