ACP-204 in Adults With Alzheimer's Disease Psychosis
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
1 other identifier
interventional
1,074
12 countries
145
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2023
Typical duration for phase_2
145 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 14, 2023
CompletedFirst Submitted
Initial submission to the registry
November 27, 2023
CompletedFirst Posted
Study publicly available on registry
December 7, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2028
April 15, 2026
January 1, 2026
4.1 years
November 27, 2023
April 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions subscales (SAPS-H+D) total score change from baseline (Substudies 1, 2A, 2B)
The SAPS-H+D subscales are a measure of two psychotic symptoms: hallucinations and delusions. The SAPS-H+D total score is the sum of the scores of the Hallucinations and Delusions subscales. The hallucinations domain score (SAPS-H) is the sum of the 7 hallucinations item scores, and the delusions domain core (SAPS-D) is the sum of the 13 delusions item scores.
From baseline to Week 6
Secondary Outcomes (1)
Clinical Global Impression-Improvement in the ADP context (CGI-I-ADP) score
Week 6
Study Arms (3)
ACP-204 30 mg
EXPERIMENTALAdministration once daily at approximately the same time of day, with or without food
ACP-204 60 mg
EXPERIMENTALAdministration once daily at approximately the same time of day, with or without food
Placebo
PLACEBO COMPARATORAdministration once daily at approximately the same time of day, with or without food
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Treatment with anti-tau therapy or donanemab within 2 months prior to Screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (145)
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
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
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
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
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
Study Record Dates
First Submitted
November 27, 2023
First Posted
December 7, 2023
Study Start
November 14, 2023
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
February 1, 2028
Last Updated
April 15, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share