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ACP-204 in Adults With Alzheimer's Disease Psychosis
NCT06159673 · ACADIA Pharmaceuticals Inc.
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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
About this study
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
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.
Study design
Enrollment target: 1074 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2023-11-14
Estimated completion: 2028-02
Last updated: 2026-04-15
Interventions
Drug: ACP-204Drug: Placebo
Primary outcomes
- • Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions subscales (SAPS-H+D) total score change from baseline (Substudies 1, 2A, 2B) (From baseline to Week 6)
Sponsor
ACADIA Pharmaceuticals Inc. · industry
Contacts & investigators
ContactChristine Murphy · contact · cmurphy@acadia-pharm.com · 858-465-7480
ContactKristen White · contact · kristen.white@acadia-pharm.com · 813-838-6468
All locations (145)
Chandler Clinical TrialsRecruiting
Chandler, Arizona, United States
Clinical Endpoint LLCRecruiting
Scottsdale, Arizona, United States
Advanced Research Center, Inc.Withdrawn
Anaheim, California, United States
ATP Clinical ResearchRecruiting
Costa Mesa, California, United States
Neuro-Pain Medical CenterRecruiting
Fresno, California, United States
National Institute of Clinical ResearchWithdrawn
Garden Grove, California, United States
Humanity Clinical Research CorpRecruiting
Aventura, Florida, United States
Arrow Clinical TrialsRecruiting
Daytona Beach, Florida, United States
First Excellent Research GroupRecruiting
Doral, Florida, United States
New Life Medical Research Center Inc.Recruiting
Hialeah, Florida, United States
Reliable Clinical Research LLC.Recruiting
Hialeah, Florida, United States
Homestead Associates in Research Inc.Recruiting
Miami, Florida, United States
Premier Clinical Research Institute, Inc.Recruiting
Miami, Florida, United States
Central Miami Medical InstituteWithdrawn
Miami, Florida, United States
Advanced Clinical Research Network, CorpRecruiting
Miami, Florida, United States
Verus Clinical ResearchRecruiting
Miami, Florida, United States
Future Care Solution, LLCRecruiting
Miami, Florida, United States
MediClear Medical & Research Center, Inc.Recruiting
Miami, Florida, United States
ABBA Medical Group LLCRecruiting
Miami, Florida, United States
Visionary Investigators NetworkWithdrawn
Miami, Florida, United States
Quantum Clinical TrialsRecruiting
Miami Beach, Florida, United States
New Med ResearchRecruiting
Miami Gardens, Florida, United States
Floridian Neuroscience InstitutueRecruiting
Miami Lakes, Florida, United States
Combined Research Orlando Phase I IVRecruiting
Orlando, Florida, United States
Psych Me Medical Research IncRecruiting
Tampa, Florida, United States
Neuroscience Research InstituteRecruiting
West Palm Beach, Florida, United States
Revive Research Institute, Inc.Withdrawn
Elgin, Illinois, United States
Grace Research, LLCRecruiting
Shreveport, Louisiana, United States
Khan Revive Research InstituteWithdrawn
Rochester Hills, Michigan, United States
Alivation Research, LLCWithdrawn
Lincoln, Nebraska, United States
Dent Neurologic InstituteWithdrawn
Amherst, New York, United States
Finger Lakes Clinical ResearchWithdrawn
Rochester, New York, United States
Regional Neurological AssociatesWithdrawn
The Bronx, New York, United States
Insight Clinical Trials LLCWithdrawn
Beachwood, Ohio, United States
Valley Medical ResearchWithdrawn
Centerville, Ohio, United States
Abington Neurological AssociatesRecruiting
Abington, Pennsylvania, United States
Horizon Clinical Research GroupRecruiting
Cypress, Texas, United States
Prolato Clinical Research Center-PattonRecruiting
Houston, Texas, United States
University of Texas Health Science CenterRecruiting
Houston, Texas, United States
Clinical Trial Network LLCRecruiting
Houston, Texas, United States
Kaleidoscope Clinical ResearchRecruiting
Houston, Texas, United States
Steven South Goldstein MD and AssociatesRecruiting
Houston, Texas, United States
World Research LinkRecruiting
Pasadena, Texas, United States
R & H Clinical Research Inc.Withdrawn
Stafford, Texas, United States
Tranquil Clinical ResearchWithdrawn
Webster, Texas, United States
L2IP - Instituto de Pesquisas Clínicas LtdaRecruiting
Brasília, Brazil
Hospital Universitario de BrasiliaRecruiting
Brasília, Brazil
CECPAR Centro de Estudos Clinicos do ParanaRecruiting
Curitiba, Brazil
TrialTech Tecnologia com Pesquisas em MedicamentosRecruiting
Curitiba, Brazil
Inst. de Neurologia de Curitiba Hospital EcovilleRecruiting
Curitiba, Brazil
Instituto Mederi de Pesquisa e SaudeRecruiting
Passo Fundo, Brazil
Hospital Moinhos de VentoRecruiting
Porto Alegre, Brazil
Nucleo de Pesquisa Clínica do Rio Grande do SulWithdrawn
Porto Alegre, Brazil
Ruschel Medicina e Pesquisa ClínicaRecruiting
Rio de Janeiro, Brazil
Facili-Centro Integrado de PsiquiatriaRecruiting
São Bernardo do Campo, Brazil
BR Trials-Ensaios Clinicos e ConsultoriaRecruiting
São Paulo, Brazil
Hospital Sao PauloRecruiting
São Paulo, Brazil
Santa Paula Hospital Clinical Research CenterRecruiting
São Paulo, Brazil
Hospital das Clínicas da Faculdade de Medicina USPWithdrawn
São Paulo, Brazil
ET Dr. Ivo Natsov - AIPSMC in PsychiatryRecruiting
Cherven Bryag, Bulgaria
Medical Center LifemedRecruiting
Kardzhali, Bulgaria
DCC "Higia"Recruiting
Pazardzhik, Bulgaria
Medical center Medconsult Pleven OODRecruiting
Pleven, Bulgaria
UMHAT Sv. Georgi EADRecruiting
Plovdiv, Bulgaria
Medical center Spectar-Plovdic EOODWithdrawn
Plovdiv, Bulgaria
Mental Health Centre - Prof. N Shipkovenski EOODRecruiting
Sofia, Bulgaria
DCC St. Vrach and St. St. Kuzma and Damian OODRecruiting
Sofia, Bulgaria
UMHAT "Alexandrovska" EADRecruiting
Sofia, Bulgaria
UMHAT Alexandrovska EADRecruiting
Sofia, Bulgaria
Medical Center Hera EOODWithdrawn
Sofia, Bulgaria
Medical Center IntermedieaWithdrawn
Sofia, Bulgaria
UMHAT Prof. Dr. St. Kirkovich ADWithdrawn
Stara Zagora, Bulgaria
Psicomed Estudios MedicosRecruiting
Antofagasta, Chile
Biomedica Research GroupRecruiting
Santiago, Chile
Especialidades Medicas L y SRecruiting
Santiago, Chile
CIC de la Universidad Catolica CICUCRecruiting
Santiago, Chile
BRAIN-SOUL THERAPY s.r.o.Recruiting
Kladno, Czech Republic, Czechia
Ad71 S.R.O.Recruiting
Prague, Czech Republic, Czechia
Fakultni nemocnice u sv. Anny v BrneRecruiting
Brno, Czechia
NEUROHK s.r.oRecruiting
Choceň, Czechia
CLINTRIAL s.r.o.Recruiting
Prague, Czechia
FORBELI s.r.o.Withdrawn
Prague, Czechia
INEP medical s.r.oWithdrawn
Prague, Czechia
Vestra Clinics s.r.o.Recruiting
Rychnov nad Kněžnou, Czechia
Hopital Neurologique BronWithdrawn
Bron, France
Centre pour Personnes ÂgéesWithdrawn
Colmar, France
Centre Memoire Ressources Recherche CMRRRecruiting
Dijon, France
CHU de Limoges-Hopital DupuytrenRecruiting
Limoges, France
Hospices Civils de Lyon HCLWithdrawn
Lyon, France
Hôpital LariboisièreRecruiting
Paris, France
Hopital BROCARecruiting
Paris, France
CHU Rouen-Hospital Charles NicolleRecruiting
Rouen, France
Hopital PurpanWithdrawn
Toulouse, France
Hôpital La GraveRecruiting
Toulouse, France
CHRU de Tours- Hopital BretonneauRecruiting
Tours, France
Hôpital de Brabois AdultesRecruiting
Vandœuvre-lès-Nancy, France
ASST degli Spedali Civili di BresciaRecruiting
Brescia, Italy
Neurologia-Fondazione Instituto G. GiglioRecruiting
Cefalù, Italy
IRCCS Neuromed Istituto Neurologico MediterraneoWithdrawn
Isernia, Italy
Ospedale San RaffaeleWithdrawn
Milan, Italy
Fondazione Policlinico Uni Campus Bio-Medico di RomaRecruiting
Roma, Italy
Policlinico Universitario Agostino GemelliRecruiting
Roma, Italy
AOU Policlinico Umberto IWithdrawn
Roma, Italy
Azienda Ospedaliera Universitaria OO. RR. S.Recruiting
Salerno, Italy
Dipartimento di Neuroscienze Rita Levi MontalciniWithdrawn
Torino, Italy
Azienda Ospedaliera Card. G. PanicoRecruiting
Tricase, Italy
Iecsi S.C.Recruiting
Monterrey, N.L, Mexico
Hospital Universitario Dr. Jose Eleuterio GonzalezRecruiting
Monterrey, Nuevo León, Mexico
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Clinical Research Institute S.CRecruiting
Estado de México, Mexico
B&B Investigaciones Medicas SCRecruiting
Mazatlán, Mexico
Health Pharma Professional Research S.A. de C.V.Recruiting
Mexico City, Mexico
Mexico Centre for Clinical Research S.A de C.VRecruiting
Mexico City, Mexico
Centro Estudios Clínicos y Esp. Médicas SC CECEMRecruiting
Nuevo León, Mexico
BIND Investigaciones S.C.Recruiting
San Luis Potosí City, Mexico
Neurociencias Estudios ClinicosRecruiting
Sinaloa, Mexico
Centro para el Des de la Med y de Asist Med Esp SCRecruiting
Sinaloa, Mexico
Clinical Hosp Center Dr Dragisa Misovic DedinjeRecruiting
Belgrade, Serbia
Clinical. Hospital Center ZvezdaraRecruiting
Belgrade, Serbia
Institute of Mental HealthRecruiting
Belgrade, Serbia
Special Hospital for Cerebrovascular Disease Sveti SavaRecruiting
Belgrade, Serbia
Special Hospital for Psychiatric DiseasesRecruiting
Gornja Toponica, Serbia
Spl. Hosp. for Psychiatric Diseases KovinWithdrawn
Kovin, Serbia
Janjic University Clinical Center KragujevacRecruiting
Kragujevac, Serbia
Jovanovic University Clinical Centre of KragujevacRecruiting
Kragujevac, Serbia
University Clinical Center KragujevacRecruiting
Kragujevac, Serbia
University Clinical Center NisRecruiting
Niš, Serbia
Spl. Hosp. for Psychiatric Diseases Sveti VraceviWithdrawn
Novi Kneževac, Serbia
Gen. Hosp. Dr Radivoj SimonovicWithdrawn
Sombor, Serbia
General Hospital ValjevoWithdrawn
Valjevo, Serbia
Gachon University Gil Medical CenterRecruiting
Incheon, South Korea
Inha University HospitalRecruiting
Incheon, South Korea
Korea University Anam HospitalRecruiting
Seoul, South Korea
Eunpyeong St. Mary's HospitalRecruiting
Seoul, South Korea
Hanyang University Seoul HospitalWithdrawn
Seoul, South Korea
Konkuk University Medical CenterWithdrawn
Seoul, South Korea
Samsung Medical CenterRecruiting
Seoul, South Korea
SMG-SNU Boramae Medical CenterRecruiting
Seoul, South Korea
Hospital Universitario Virgen MacarenaRecruiting
Seville, Spain
Hospital Provincial de ZamoraRecruiting
Zamora, Spain
Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting
Kaohsiung City, Taiwan
E-DA HospitalRecruiting
Kaohsiung City, Taiwan
Taipei Medical University-Shuang Ho HospitalWithdrawn
New Taipei City, Taiwan
National Cheng Kung University HospitalRecruiting
Tainan, Taiwan
National Taiwan University HospitalRecruiting
Taipei, Taiwan