ACP-204 in Adults With Alzheimer's Disease Psychosis
- Registration Number
- NCT06159673
- Lead Sponsor
- ACADIA Pharmaceuticals Inc.
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1074
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Administration once daily at approximately the same time of day, with or without food ACP-204 60 mg ACP-204 Administration once daily at approximately the same time of day, with or without food ACP-204 30 mg ACP-204 Administration once daily at approximately the same time of day, with or without food
- Primary Outcome Measures
Name Time Method 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 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.
- Secondary Outcome Measures
Name Time Method Clinical Global Impression-Improvement in the ADP context (CGI-I-ADP) score Week 6 The CGI-I scale is a clinician-rated, 7-point scale used to rate the improvement in symptoms at the time of assessment, relative to the symptoms at Baseline. The CGI-I-ADP scale is the CGI-I scale applied in the ADP context, in which hallucinations and delusions are the symptoms of interest.
Trial Locations
- Locations (117)
Hanyang University Seoul Hospital
🇰🇷Seoul, Korea, Republic of
Khan Revive Research Institute
🇺🇸Rochester Hills, Michigan, United States
Alivation Research, LLC
🇺🇸Lincoln, Nebraska, United States
Dent Neurologic Institute
🇺🇸Amherst, New York, United States
R & H Clinical Research Inc.
🇺🇸Stafford, Texas, 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
Arrow Clinical Trials
🇺🇸Daytona Beach, Florida, United States
New Life Medical Research Center Inc.
🇺🇸Hialeah, Florida, United States
Reliable Clinical Research LLC.
🇺🇸Hialeah, Florida, United States
Quantum Clinical Trials
🇺🇸Miami Beach, Florida, United States
Floridian Neuroscience Institutue
🇺🇸Miami Lakes, 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
Visionary Investigators Network
🇺🇸Miami, Florida, United States
Neuroscience Research Institute
🇺🇸West Palm Beach, Florida, United States
Revive Research Institute, Inc.
🇺🇸Elgin, Illinois, United States
Regional Neurological Associates
🇺🇸Bronx, New York, United States
Finger Lakes Clinical Research
🇺🇸Rochester, New York, United States
Insight Clinical Trials LLC
🇺🇸Beachwood, Ohio, United States
Valley Medical Research
🇺🇸Centerville, Ohio, United States
Abington Neurological Associates
🇺🇸Abington, Pennsylvania, 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
Tranquil Clinical Research
🇺🇸Webster, Texas, United States
Hospital Universitario de Brasilia
🇧🇷Brasília, 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
🇧🇷Sao Bernardo do Campo, Brazil
BR Trials-Ensaios Clinicos e Consultoria
🇧🇷São Paulo, Brazil
Hospital Sao Paulo
🇧🇷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
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
Medical Center Hera EOOD
🇧🇬Sofia, Bulgaria
Medical Center Intermediea
🇧🇬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.
🇨🇿Praha, Czech Republic, Czechia
Fakultni nemocnice u sv. Anny v Brne
🇨🇿Brno, Czechia
NEUROHK s.r.o
🇨🇿Choceň, Czechia
CLINTRIAL s.r.o.
🇨🇿Praha 10, Czechia
FORBELI s.r.o.
🇨🇿Praha 6, Czechia
INEP medical s.r.o
🇨🇿Praha 8, Czechia
Vestra Clinics s.r.o.
🇨🇿Rychnov Nad Kněžnou, Czechia
Hopital Neurologique Bron
🇫🇷Bron, France
Centre pour Personnes Âgées
🇫🇷Colmar, France
Hospices Civils de Lyon HCL
🇫🇷Lyon, France
Hôpital Lariboisière
🇫🇷Paris, France
Hopital BROCA
🇫🇷Paris, France
Hôpital La Grave
🇫🇷Toulouse CEDEX 9, France
Hopital Purpan
🇫🇷Toulouse, France
CHRU de Tours- Hopital Bretonneau
🇫🇷Tours Cedex 9, France
Hôpital de Brabois Adultes
🇫🇷Vandœuvre-lès-Nancy, France
ASST degli Spedali Civili di Brescia
🇮🇹Brescia, Italy
IRCCS Neuromed Istituto Neurologico Mediterraneo
🇮🇹Isernia, Italy
Ospedale San Raffaele
🇮🇹Milano, Italy
Fondazione Policlinico Uni Campus Bio-Medico di Roma
🇮🇹Roma, Italy
Policlinico Universitario Agostino Gemelli
🇮🇹Roma, Italy
AOU Policlinico Umberto I
🇮🇹Roma, Italy
Azienda Ospedaliera Universitaria OO. RR. S.
🇮🇹Salerno, Italy
Dipartimento di Neuroscienze Rita Levi Montalcini
🇮🇹Torino, Italy
Azienda Ospedaliera Card. G. Panico
🇮🇹Tricase, Italy
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Inha University Hospital
🇰🇷Incheon, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Eunpyeong St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Konkuk University Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
SMG-SNU Boramae Medical Center
🇰🇷Seoul, Korea, Republic of
Iecsi S.C.
🇲🇽Monterrey, N.L, Mexico
Mexico Centre for Clinical Research S.A de C.V
🇲🇽Ciudad de Mexico, Mexico
Hospital Universitario Dr. Gonzalo Valdes Valdes
🇲🇽Coahuila, Mexico
Clinical Research Institute S.C
🇲🇽Estado De Mexico, Mexico
BIND Investigaciones S.C.
🇲🇽San Luis Potosí, Mexico
Centro para el Des de la Med y de Asist Med Esp SC
🇲🇽Sinaloa, Mexico
Clinical Hosp Center Dr Dragisa Misovic Dedinje
🇷🇸Belgrade, Serbia
Clinical. Hospital Center Zvezdara
🇷🇸Belgrade, Serbia
Institute of Mental Health
🇷🇸Belgrade, Serbia
Spl. Hosp. for Psychiatric Diseases Kovin
🇷🇸Kovin, Serbia
Janjic University Clinical Center Kragujevac
🇷🇸Kragujevac, Serbia
Jovanovic University Clinical Centre of Kragujevac
🇷🇸Kragujevac, Serbia
University Clinical Center Kragujevac
🇷🇸Kragujevac, Serbia
University Clinical Center Nis
🇷🇸Niš, Serbia
Spl. Hosp. for Psychiatric Diseases Sveti Vracevi
🇷🇸Novi Kneževac, Serbia
Gen. Hosp. Dr Radivoj Simonovic
🇷🇸Sombor, Serbia
General Hospital Valjevo
🇷🇸Valjevo, Serbia
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain
Hospital Provincial de Zamora
🇪🇸Zamora, Spain
E-DA Hospital
🇨🇳Kaohsiung City, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
🇨🇳Kaohsiung, Taiwan
Taipei Medical University-Shuang Ho Hospital
🇨🇳New Taipei City, Taiwan
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan