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

Status: Recruiting
Location: See all (124) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 55
Maximum Age: 95
Healthy Volunteers: f
View:

• 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

Locations
United States
Arizona
Chandler Clinical Trials
RECRUITING
Chandler
Clinical Endpoint LLC
RECRUITING
Scottsdale
California
Advanced Research Center, Inc.
RECRUITING
Anaheim
ATP Clinical Research
RECRUITING
Costa Mesa
Neuro-Pain Medical Center
RECRUITING
Fresno
National Institute of Clinical Research
RECRUITING
Garden Grove
Florida
Arrow Clinical Trials
RECRUITING
Daytona Beach
First Excellent Research Group
RECRUITING
Doral
New Life Medical Research Center Inc.
RECRUITING
Hialeah
Reliable Clinical Research LLC.
RECRUITING
Hialeah
ABBA Medical Group LLC
RECRUITING
Miami
Advanced Clinical Research Network, Corp
RECRUITING
Miami
Central Miami Medical Institute
WITHDRAWN
Miami
Future Care Solution, LLC
RECRUITING
Miami
Homestead Associates in Research Inc.
RECRUITING
Miami
MediClear Medical & Research Center, Inc.
RECRUITING
Miami
Premier Clinical Research Institute, Inc.
RECRUITING
Miami
Verus Clinical Research
RECRUITING
Miami
Visionary Investigators Network
RECRUITING
Miami
Quantum Clinical Trials
RECRUITING
Miami Beach
New Med Research
RECRUITING
Miami Gardens
Floridian Neuroscience Institutue
RECRUITING
Miami Lakes
Combined Research Orlando Phase I IV
RECRUITING
Orlando
Neuroscience Research Institute
RECRUITING
West Palm Beach
Illinois
Revive Research Institute, Inc.
WITHDRAWN
Elgin
Louisiana
Grace Research, LLC
RECRUITING
Shreveport
Michigan
Khan Revive Research Institute
WITHDRAWN
Rochester Hills
Nebraska
Alivation Research, LLC
WITHDRAWN
Lincoln
New York
Dent Neurologic Institute
WITHDRAWN
Amherst
Finger Lakes Clinical Research
WITHDRAWN
Rochester
Regional Neurological Associates
WITHDRAWN
The Bronx
Ohio
Insight Clinical Trials LLC
WITHDRAWN
Beachwood
Valley Medical Research
WITHDRAWN
Centerville
Pennsylvania
Abington Neurological Associates
RECRUITING
Abington
Texas
Clinical Trial Network LLC
RECRUITING
Houston
Kaleidoscope Clinical Research
RECRUITING
Houston
Prolato Clinical Research Center-Patton
RECRUITING
Houston
Steven South Goldstein MD and Associates
RECRUITING
Houston
University of Texas Health Science Center
RECRUITING
Houston
World Research Link
RECRUITING
Pasadena
R & H Clinical Research Inc.
RECRUITING
Stafford
Tranquil Clinical Research
RECRUITING
Webster
Other Locations
Brazil
Hospital Universitario de Brasilia
RECRUITING
Brasília
Inst. de Neurologia de Curitiba Hospital Ecoville
RECRUITING
Curitiba
TrialTech Tecnologia com Pesquisas em Medicamentos
RECRUITING
Curitiba
Instituto Mederi de Pesquisa e Saude
RECRUITING
Passo Fundo
Hospital Moinhos de Vento
RECRUITING
Porto Alegre
Nucleo de Pesquisa Clínica do Rio Grande do Sul
RECRUITING
Porto Alegre
Ruschel Medicina e Pesquisa Clínica
RECRUITING
Rio De Janeiro
Facili-Centro Integrado de Psiquiatria
RECRUITING
São Bernardo Do Campo
BR Trials-Ensaios Clinicos e Consultoria
RECRUITING
São Paulo
Hospital das Clínicas da Faculdade de Medicina USP
WITHDRAWN
São Paulo
Hospital Sao Paulo
RECRUITING
São Paulo
Bulgaria
ET Dr. Ivo Natsov - AIPSMC in Psychiatry
RECRUITING
Cherven Bryag
Medical Center Lifemed
RECRUITING
Kardzhali
DCC Higia
RECRUITING
Pazardzhik
Medical center Medconsult Pleven OOD
RECRUITING
Pleven
Medical center Spectar-Plovdic EOOD
WITHDRAWN
Plovdiv
DCC St. Vrach and St. St. Kuzma and Damian OOD
RECRUITING
Sofia
Medical Center Hera EOOD
RECRUITING
Sofia
Medical Center Intermediea
RECRUITING
Sofia
Mental Health Centre - Prof. N Shipkovenski EOOD
RECRUITING
Sofia
UMHAT Alexandrovska EAD
RECRUITING
Sofia
UMHAT Prof. Dr. St. Kirkovich AD
WITHDRAWN
Stara Zagora
Chile
Psicomed Estudios Medicos
RECRUITING
Antofagasta
Biomedica Research Group
RECRUITING
Santiago
CIC de la Universidad Catolica CICUC
RECRUITING
Santiago
Especialidades Medicas L y S
RECRUITING
Santiago
France
Hopital Neurologique Bron
RECRUITING
Bron
Centre pour Personnes Âgées
RECRUITING
Colmar
Centre Memoire Ressources Recherche CMRR
RECRUITING
Dijon
CHU de Limoges-Hopital Dupuytren
RECRUITING
Limoges
Hospices Civils de Lyon HCL
RECRUITING
Lyon
Hopital BROCA
RECRUITING
Paris
Hôpital Lariboisière
RECRUITING
Paris
CHU Rouen-Hospital Charles Nicolle
RECRUITING
Rouen
Hôpital La Grave
RECRUITING
Toulouse
Hopital Purpan
RECRUITING
Toulouse
CHRU de Tours- Hopital Bretonneau
RECRUITING
Tours
Hôpital de Brabois Adultes
RECRUITING
Vandœuvre-lès-nancy
Italy
ASST degli Spedali Civili di Brescia
RECRUITING
Brescia
IRCCS Neuromed Istituto Neurologico Mediterraneo
RECRUITING
Isernia
Ospedale San Raffaele
WITHDRAWN
Milan
AOU Policlinico Umberto I
RECRUITING
Roma
Fondazione Policlinico Uni Campus Bio-Medico di Roma
RECRUITING
Roma
Policlinico Universitario Agostino Gemelli
RECRUITING
Roma
Azienda Ospedaliera Universitaria OO. RR. S.
RECRUITING
Salerno
Dipartimento di Neuroscienze Rita Levi Montalcini
RECRUITING
Torino
Azienda Ospedaliera Card. G. Panico
RECRUITING
Tricase
Mexico
Hospital Universitario Dr. Gonzalo Valdes Valdes
RECRUITING
Coahuila
Clinical Research Institute S.C
RECRUITING
Estado De México
Mexico Centre for Clinical Research S.A de C.V
RECRUITING
Mexico City
Hospital Universitario Dr. Jose Eleuterio Gonzalez
RECRUITING
Monterrey
Iecsi S.C.
RECRUITING
Monterrey
BIND Investigaciones S.C.
RECRUITING
San Luis Potosí City
Centro para el Des de la Med y de Asist Med Esp SC
RECRUITING
Sinaloa
Neurociencias Estudios Clinicos
RECRUITING
Sinaloa
Republic of Korea
Gachon University Gil Medical Center
RECRUITING
Incheon
Inha University Hospital
RECRUITING
Incheon
Eunpyeong St. Mary's Hospital
RECRUITING
Seoul
Hanyang University Seoul Hospital
RECRUITING
Seoul
Konkuk University Medical Center
RECRUITING
Seoul
Korea University Anam Hospital
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
SMG-SNU Boramae Medical Center
RECRUITING
Seoul
Serbia
Clinical Hosp Center Dr Dragisa Misovic Dedinje
RECRUITING
Belgrade
Clinical. Hospital Center Zvezdara
RECRUITING
Belgrade
Institute of Mental Health
RECRUITING
Belgrade
Special Hospital for Psychiatric Diseases
RECRUITING
Gornja Toponica
Spl. Hosp. for Psychiatric Diseases Kovin
RECRUITING
Kovin
Janjic University Clinical Center Kragujevac
RECRUITING
Kragujevac
Jovanovic University Clinical Centre of Kragujevac
RECRUITING
Kragujevac
University Clinical Center Kragujevac
RECRUITING
Kragujevac
University Clinical Center Nis
RECRUITING
Niš
Spl. Hosp. for Psychiatric Diseases Sveti Vracevi
RECRUITING
Novi Kneževac
Gen. Hosp. Dr Radivoj Simonovic
RECRUITING
Sombor
General Hospital Valjevo
RECRUITING
Valjevo
Spain
Hospital Universitario Virgen Macarena
RECRUITING
Seville
Hospital Provincial de Zamora
RECRUITING
Zamora
Taiwan
E-DA Hospital
RECRUITING
Kaohsiung City
Kaohsiung Medical University Chung-Ho Memorial Hospital
RECRUITING
Kaohsiung City
Taipei Medical University-Shuang Ho Hospital
RECRUITING
New Taipei City
National Cheng Kung University Hospital
RECRUITING
Tainan City
National Taiwan University Hospital
RECRUITING
Taipei
Contact Information
Primary
Christine Murphy
cmurphy@acadia-pharm.com
858-465-7480
Backup
Kristen White
kristen.white@acadia-pharm.com
813-838-6468
Time Frame
Start Date: 2023-11-14
Estimated Completion Date: 2028-02
Participants
Target number of participants: 1074
Treatments
Experimental: ACP-204 30 mg
Administration once daily at approximately the same time of day, with or without food
Experimental: ACP-204 60 mg
Administration once daily at approximately the same time of day, with or without food
Placebo_comparator: Placebo
Administration once daily at approximately the same time of day, with or without food
Related Therapeutic Areas
Sponsors
Leads: ACADIA Pharmaceuticals Inc.

This content was sourced from clinicaltrials.gov