ACP-204 in Adults With Alzheimer's Disease Psychosis

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).

Interventions

• ACP-204 · DRUG

  ACP-204 is a potent and selective antagonist/inverse agonist of 5-hydroxytryptamine (serotonin) receptor subtype 2A.

• Placebo · DRUG

  ACP-204 matching placebo

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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.

Sites (148)

• Chandler Clinical Trials, Chandler, Arizona · RECRUITING
• Clinical Endpoint LLC, Scottsdale, Arizona · RECRUITING
• Advanced Research Center, Inc., Anaheim, California · WITHDRAWN
• ATP Clinical Research, Costa Mesa, California · RECRUITING
• Neuro-Pain Medical Center, Fresno, California · RECRUITING
• National Institute of Clinical Research, Garden Grove, California · TERMINATED
• Humanity Clinical Research Corp, Aventura, Florida · RECRUITING
• Arrow Clinical Trials, Daytona Beach, Florida · RECRUITING
• First Excellent Research Group, Doral, Florida · RECRUITING
• New Life Medical Research Center Inc., Hialeah, Florida · RECRUITING
• Reliable Clinical Research LLC., Hialeah, Florida · RECRUITING
• Homestead Associates in Research Inc., Miami, Florida · RECRUITING
• Premier Clinical Research Institute, Inc., Miami, Florida · RECRUITING
• Central Miami Medical Institute, Miami, Florida · WITHDRAWN
• Advanced Clinical Research Network, Corp, Miami, Florida · RECRUITING
• Verus Clinical Research, Miami, Florida · RECRUITING
• Future Care Solution, LLC, Miami, Florida · RECRUITING
• MediClear Medical & Research Center, Inc., Miami, Florida · RECRUITING
• ABBA Medical Group LLC, Miami, Florida · RECRUITING
• Visionary Investigators Network, Miami, Florida · WITHDRAWN
• Quantum Clinical Trials, Miami Beach, Florida · RECRUITING
• New Med Research, Miami Gardens, Florida · RECRUITING
• Floridian Neuroscience Institutue, Miami Lakes, Florida · RECRUITING
• Combined Research Orlando Phase I IV, Orlando, Florida · RECRUITING
• Psych Me Medical Research Inc, Tampa, Florida · WITHDRAWN
• Neuroscience Research Institute, West Palm Beach, Florida · RECRUITING
• Revive Research Institute, Inc., Elgin, Illinois · WITHDRAWN
• Grace Research, LLC, Shreveport, Louisiana · RECRUITING
• Khan Revive Research Institute, Rochester Hills, Michigan · WITHDRAWN
• Tekton Research, LLC, St Louis, Missouri · RECRUITING
• Alivation Research, LLC, Lincoln, Nebraska · WITHDRAWN
• Dent Neurologic Institute, Amherst, New York · WITHDRAWN
• Finger Lakes Clinical Research, Rochester, New York · WITHDRAWN
• Regional Neurological Associates, The Bronx, New York · WITHDRAWN
• Insight Clinical Trials LLC, Beachwood, Ohio · WITHDRAWN
• Valley Medical Research, Centerville, Ohio · WITHDRAWN
• Abington Neurological Associates, Abington, Pennsylvania · RECRUITING
• Horizon Clinical Research Group, Cypress, Texas · RECRUITING
• Prolato Clinical Research Center-Patton, Houston, Texas · RECRUITING
• University of Texas Health Science Center, Houston, Texas · TERMINATED
• Clinical Trial Network LLC, Houston, Texas · RECRUITING
• Kaleidoscope Clinical Research, Houston, Texas · RECRUITING
• Steven South Goldstein MD and Associates, Houston, Texas · RECRUITING
• World Research Link, Pasadena, Texas · RECRUITING
• R & H Clinical Research Inc., Stafford, Texas · WITHDRAWN
• Tranquil Clinical Research, Webster, Texas · WITHDRAWN
• Clinica Neurologica e Neurocirurgica de Joinville, Joinville, Santa Catarina, Brazil · RECRUITING
• L2IP - Instituto de Pesquisas Clínicas Ltda, Brasília, Brazil · RECRUITING
• Hospital Universitario de Brasilia, Brasília, Brazil · RECRUITING
• CECPAR Centro de Estudos Clinicos do Parana, Curitiba, Brazil · RECRUITING
• TrialTech Tecnologia com Pesquisas em Medicamentos, Curitiba, Brazil · RECRUITING
• Inst. de Neurologia de Curitiba Hospital Ecoville, Curitiba, Brazil · RECRUITING
• Instituto Mederi de Pesquisa e Saude, Passo Fundo, Brazil · RECRUITING
• Hospital Moinhos de Vento, Porto Alegre, Brazil · RECRUITING
• Nucleo de Pesquisa Clínica do Rio Grande do Sul, Porto Alegre, Brazil · WITHDRAWN
• Ruschel Medicina e Pesquisa Clínica, Rio de Janeiro, Brazil · RECRUITING
• Facili-Centro Integrado de Psiquiatria, São Bernardo do Campo, Brazil · RECRUITING
• BR Trials-Ensaios Clinicos e Consultoria, São Paulo, Brazil · RECRUITING
• Hospital Sao Paulo, São Paulo, Brazil · RECRUITING
• Santa Paula Hospital Clinical Research Center, São Paulo, Brazil · RECRUITING
• Hospital das Clínicas da Faculdade de Medicina USP, São Paulo, Brazil · WITHDRAWN
• ET Dr. Ivo Natsov - AIPSMC in Psychiatry, Cherven Bryag, Bulgaria · ACTIVE_NOT_RECRUITING
• Medical Center Lifemed, Kardzhali, Bulgaria · WITHDRAWN
• DCC "Higia", Pazardzhik, Bulgaria · ACTIVE_NOT_RECRUITING
• Medical center Medconsult Pleven OOD, Pleven, Bulgaria · ACTIVE_NOT_RECRUITING
• UMHAT Sv. Georgi EAD, Plovdiv, Bulgaria · ACTIVE_NOT_RECRUITING
• Medical center Spectar-Plovdic EOOD, Plovdiv, Bulgaria · WITHDRAWN
• Mental Health Centre - Prof. N Shipkovenski EOOD, Sofia, Bulgaria · ACTIVE_NOT_RECRUITING
• DCC St. Vrach and St. St. Kuzma and Damian OOD, Sofia, Bulgaria · ACTIVE_NOT_RECRUITING
• UMHAT "Alexandrovska" EAD, Sofia, Bulgaria · ACTIVE_NOT_RECRUITING
• UMHAT Alexandrovska EAD, Sofia, Bulgaria · ACTIVE_NOT_RECRUITING
• Medical Center Hera EOOD, Sofia, Bulgaria · WITHDRAWN
• Medical Center Intermediea, Sofia, Bulgaria · WITHDRAWN
• UMHAT Prof. Dr. St. Kirkovich AD, Stara Zagora, Bulgaria · WITHDRAWN
• Psicomed Estudios Medicos, Antofagasta, Chile · RECRUITING
• Biomedica Research Group, Santiago, Chile · RECRUITING
• Especialidades Medicas L y S, Santiago, Chile · RECRUITING
• CIC de la Universidad Catolica CICUC, Santiago, Chile · RECRUITING
• BRAIN-SOUL THERAPY s.r.o., Kladno, Czech Republic, Czechia · ACTIVE_NOT_RECRUITING
• Ad71 S.R.O., Prague, Czech Republic, Czechia · ACTIVE_NOT_RECRUITING
• Fakultni nemocnice u sv. Anny v Brne, Brno, Czechia · ACTIVE_NOT_RECRUITING
• NEUROHK s.r.o, Choceň, Czechia · ACTIVE_NOT_RECRUITING
• CLINTRIAL s.r.o., Prague, Czechia · ACTIVE_NOT_RECRUITING
• FORBELI s.r.o., Prague, Czechia · WITHDRAWN
• INEP medical s.r.o, Prague, Czechia · WITHDRAWN
• Vestra Clinics s.r.o., Rychnov nad Kněžnou, Czechia · ACTIVE_NOT_RECRUITING
• Hopital Neurologique Bron, Bron, France · WITHDRAWN
• Centre pour Personnes Âgées, Colmar, France · WITHDRAWN
• Centre Memoire Ressources Recherche CMRR, Dijon, France · ACTIVE_NOT_RECRUITING
• CHU de Limoges-Hopital Dupuytren, Limoges, France · ACTIVE_NOT_RECRUITING
• Hospices Civils de Lyon HCL, Lyon, France · WITHDRAWN
• Hôpital Lariboisière, Paris, France · ACTIVE_NOT_RECRUITING
• Hopital BROCA, Paris, France · ACTIVE_NOT_RECRUITING
• CHU Rouen-Hospital Charles Nicolle, Rouen, France · ACTIVE_NOT_RECRUITING
• Hopital Purpan, Toulouse, France · WITHDRAWN
• Hôpital La Grave, Toulouse, France · ACTIVE_NOT_RECRUITING
• CHRU de Tours- Hopital Bretonneau, Tours, France · ACTIVE_NOT_RECRUITING
• Hôpital de Brabois Adultes, Vandœuvre-lès-Nancy, France · ACTIVE_NOT_RECRUITING
• ASST degli Spedali Civili di Brescia, Brescia, Italy · ACTIVE_NOT_RECRUITING
• Neurologia-Fondazione Instituto G. Giglio, Cefalù, Italy · ACTIVE_NOT_RECRUITING
• IRCCS Neuromed Istituto Neurologico Mediterraneo, Isernia, Italy · WITHDRAWN
• Ospedale San Raffaele, Milan, Italy · WITHDRAWN
• Fondazione Policlinico Uni Campus Bio-Medico di Roma, Roma, Italy · ACTIVE_NOT_RECRUITING
• Policlinico Universitario Agostino Gemelli, Roma, Italy · ACTIVE_NOT_RECRUITING
• AOU Policlinico Umberto I, Roma, Italy · WITHDRAWN
• Azienda Ospedaliera Universitaria OO. RR. S., Salerno, Italy · ACTIVE_NOT_RECRUITING
• Dipartimento di Neuroscienze Rita Levi Montalcini, Torino, Italy · WITHDRAWN
• Azienda Ospedaliera Card. G. Panico, Tricase, Italy · ACTIVE_NOT_RECRUITING
• Iecsi S.C., Monterrey, N.L, Mexico · RECRUITING
• Hospital Universitario Dr. Jose Eleuterio Gonzalez, Monterrey, Nuevo León, Mexico · RECRUITING
• Hospital Universitario Dr. Gonzalo Valdes Valdes, Coahuila, Mexico · RECRUITING
• Clinical Research Institute S.C, Estado de México, Mexico · RECRUITING
• B&B Investigaciones Medicas SC, Mazatlán, Mexico · RECRUITING
• Health Pharma Professional Research S.A. de C.V., Mexico City, Mexico · RECRUITING
• Mexico Centre for Clinical Research S.A de C.V, Mexico City, Mexico · RECRUITING
• Centro Estudios Clínicos y Esp. Médicas SC CECEM, Nuevo León, Mexico · RECRUITING
• BIND Investigaciones S.C., San Luis Potosí City, Mexico · RECRUITING
• Neurociencias Estudios Clinicos, Sinaloa, Mexico · RECRUITING
• Centro para el Des de la Med y de Asist Med Esp SC, Sinaloa, Mexico · RECRUITING
• Clinical Hosp Center Dr Dragisa Misovic Dedinje, Belgrade, Serbia · ACTIVE_NOT_RECRUITING
• Clinical. Hospital Center Zvezdara, Belgrade, Serbia · ACTIVE_NOT_RECRUITING
• Institute of Mental Health, Belgrade, Serbia · ACTIVE_NOT_RECRUITING
• Special Hospital for Cerebrovascular Disease Sveti Sava, Belgrade, Serbia · ACTIVE_NOT_RECRUITING
• University Clinic Centre of Serbia, Belgrade, Serbia · RECRUITING
• Special Hospital for Psychiatric Diseases, Gornja Toponica, Serbia · ACTIVE_NOT_RECRUITING
• Spl. Hosp. for Psychiatric Diseases Kovin, Kovin, Serbia · TERMINATED
• Janjic University Clinical Center Kragujevac, Kragujevac, Serbia · ACTIVE_NOT_RECRUITING
• Jovanovic University Clinical Centre of Kragujevac, Kragujevac, Serbia · ACTIVE_NOT_RECRUITING
• University Clinical Center Kragujevac, Kragujevac, Serbia · ACTIVE_NOT_RECRUITING
• University Clinical Center Nis, Niš, Serbia · ACTIVE_NOT_RECRUITING
• Spl. Hosp. for Psychiatric Diseases Sveti Vracevi, Novi Kneževac, Serbia · WITHDRAWN
• Gen. Hosp. Dr Radivoj Simonovic, Sombor, Serbia · WITHDRAWN
• General Hospital Valjevo, Valjevo, Serbia · WITHDRAWN
• Gachon University Gil Medical Center, Incheon, South Korea · RECRUITING
• Inha University Hospital, Incheon, South Korea · RECRUITING
• Korea University Anam Hospital, Seoul, South Korea · RECRUITING
• Eunpyeong St. Mary's Hospital, Seoul, South Korea · TERMINATED
• Hanyang University Seoul Hospital, Seoul, South Korea · TERMINATED
• Konkuk University Medical Center, Seoul, South Korea · WITHDRAWN
• Samsung Medical Center, Seoul, South Korea · RECRUITING
• SMG-SNU Boramae Medical Center, Seoul, South Korea · RECRUITING
• Hospital Universitario Virgen Macarena, Seville, Spain · ACTIVE_NOT_RECRUITING
• Hospital Provincial de Zamora, Zamora, Spain · ACTIVE_NOT_RECRUITING
• Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City, Taiwan · RECRUITING
• E-DA Hospital, Kaohsiung City, Taiwan · RECRUITING
• Taipei Medical University-Shuang Ho Hospital, New Taipei City, Taiwan · WITHDRAWN
• National Cheng Kung University Hospital, Tainan, Taiwan · WITHDRAWN
• National Taiwan University Hospital, Taipei, Taiwan · RECRUITING