Clinical trial NCT06159673: ACP-204 in Adults With Alzheimer's Disease Psychosis
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Alzheimer's Disease Psychosis
Keywords: Alzheimer's disease psychosis
Hallucinations
Delusions
Lead sponsor: ACADIA Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2023-12-07
Enrollment: 1074
Sex: ALL
Minimum age (years): 55
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions subscales (SAPS-H+D) total score change from baseline (Substudies 1, 2A, 2B)
timeFrame: From baseline to Week 6
Secondary outcomes:
measure: Clinical Global Impression-Improvement in the ADP context (CGI-I-ADP) score
timeFrame: Week 6
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Advanced Research Center, Inc.
state: California
city: Costa Mesa
country: United States
facility: ATP Clinical Research
state: California
city: Fresno
country: United States
facility: Neuro-Pain Medical Center
state: California
city: Garden Grove
country: United States
facility: National Institute of Clinical Research
state: California
city: Daytona Beach
country: United States
facility: Arrow Clinical Trials
state: Florida
city: Hialeah
country: United States
facility: New Life Medical Research Center Inc.
state: Florida
city: Hialeah
country: United States
facility: Reliable Clinical Research LLC.
state: Florida
city: Miami Beach
country: United States
facility: Quantum Clinical Trials
state: Florida
city: Miami Gardens
country: United States
facility: New Med Research
state: Florida
city: Miami Lakes
country: United States
facility: Floridian Neuroscience Institutue
state: Florida
city: Miami
country: United States
facility: Homestead Associates in Research Inc.
state: Florida
city: Miami
country: United States
facility: Premier Clinical Research Institute, Inc.
state: Florida
city: Miami
country: United States
facility: Central Miami Medical Institute
state: Florida
city: Miami
country: United States
facility: Advanced Clinical Research Network, Corp
state: Florida
city: Miami
country: United States
facility: Verus Clinical Research
state: Florida
city: Miami
country: United States
facility: Future Care Solution, LLC
state: Florida
city: Miami
country: United States
facility: MediClear Medical & Research Center, Inc.
state: Florida
city: Miami
country: United States
facility: Visionary Investigators Network
state: Florida
city: West Palm Beach
country: United States
facility: Neuroscience Research Institute
state: Florida
city: Elgin
country: United States
facility: Revive Research Institute, Inc.
state: Illinois
city: Rochester Hills
country: United States
facility: Khan Revive Research Institute
state: Michigan
city: Lincoln
country: United States
facility: Alivation Research, LLC
state: Nebraska
city: Amherst
country: United States
facility: Dent Neurologic Institute
state: New York
city: Bronx
country: United States
facility: Regional Neurological Associates
state: New York
city: Rochester
country: United States
facility: Finger Lakes Clinical Research
state: New York
city: Beachwood
country: United States
facility: Insight Clinical Trials LLC
state: Ohio
city: Centerville
country: United States
facility: Valley Medical Research
state: Ohio
city: Abington
country: United States
facility: Abington Neurological Associates
state: Pennsylvania
city: Houston
country: United States
facility: Prolato Clinical Research Center-Patton
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center
state: Texas
city: Houston
country: United States
facility: Clinical Trial Network LLC
state: Texas
city: Houston
country: United States
facility: Kaleidoscope Clinical Research
state: Texas
city: Pasadena
country: United States
facility: World Research Link
state: Texas
city: Stafford
country: United States
facility: R & H Clinical Research Inc.
state: Texas
city: Webster
country: United States
facility: Tranquil Clinical Research
state: Texas
city: Brasília
country: Brazil
facility: Hospital Universitario de Brasilia
city: Curitiba
country: Brazil
facility: TrialTech Tecnologia com Pesquisas em Medicamentos
city: Curitiba
country: Brazil
facility: Inst. de Neurologia de Curitiba Hospital Ecoville
city: Passo Fundo
country: Brazil
facility: Instituto Mederi de Pesquisa e Saude
city: Porto Alegre
country: Brazil
facility: Hospital Moinhos de Vento
city: Porto Alegre
country: Brazil
facility: Nucleo de Pesquisa Clínica do Rio Grande do Sul
city: Rio De Janeiro
country: Brazil
facility: Ruschel Medicina e Pesquisa Clínica
city: Sao Bernardo do Campo
country: Brazil
facility: Facili-Centro Integrado de Psiquiatria
city: São Paulo
country: Brazil
facility: BR Trials-Ensaios Clinicos e Consultoria
city: São Paulo
country: Brazil
facility: Hospital Sao Paulo
city: São Paulo
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina USP
city: Cherven Bryag
country: Bulgaria
facility: ET Dr. Ivo Natsov - AIPSMC in Psychiatry
city: Kardzhali
country: Bulgaria
facility: Medical Center Lifemed
city: Pazardzhik
country: Bulgaria
facility: DCC "Higia"
city: Pleven
country: Bulgaria
facility: Medical center Medconsult Pleven OOD
city: Plovdiv
country: Bulgaria
facility: Medical center Spectar-Plovdic EOOD
city: Sofia
country: Bulgaria
facility: Mental Health Centre - Prof. N Shipkovenski EOOD
city: Sofia
country: Bulgaria
facility: DCC St. Vrach and St. St. Kuzma and Damian OOD
city: Sofia
country: Bulgaria
facility: UMHAT "Alexandrovska" EAD
city: Sofia
country: Bulgaria
facility: Medical Center Hera EOOD
city: Sofia
country: Bulgaria
facility: Medical Center Intermediea
city: Stara Zagora
country: Bulgaria
facility: UMHAT Prof. Dr. St. Kirkovich AD
city: Antofagasta
country: Chile
facility: Psicomed Estudios Medicos
city: Santiago
country: Chile
facility: Biomedica Research Group
city: Santiago
country: Chile
facility: Especialidades Medicas L y S
city: Santiago
country: Chile
facility: CIC de la Universidad Catolica CICUC
city: Kladno
country: Czechia
facility: BRAIN-SOUL THERAPY s.r.o.
state: Czech Republic
city: Praha
country: Czechia
facility: Ad71 S.R.O.
state: Czech Republic
city: Brno
country: Czechia
facility: Fakultni nemocnice u sv. Anny v Brne
city: Choceň
country: Czechia
facility: NEUROHK s.r.o
city: Praha 10
country: Czechia
facility: CLINTRIAL s.r.o.
city: Praha 6
country: Czechia
facility: FORBELI s.r.o.
city: Praha 8
country: Czechia
facility: INEP medical s.r.o
city: Rychnov Nad Kněžnou
country: Czechia
facility: Vestra Clinics s.r.o.
city: Bron
country: France
facility: Hopital Neurologique Bron
city: Colmar
country: France
facility: Centre pour Personnes Âgées
city: Lyon
country: France
facility: Hospices Civils de Lyon HCL
city: Paris
country: France
facility: Hôpital Lariboisière
city: Paris
country: France
facility: Hopital BROCA
city: Toulouse CEDEX 9
country: France
facility: Hôpital La Grave
city: Toulouse
country: France
facility: Hopital Purpan
city: Tours Cedex 9
country: France
facility: CHRU de Tours- Hopital Bretonneau
city: Vandœuvre-lès-Nancy
country: France
facility: Hôpital de Brabois Adultes
city: Brescia
country: Italy
facility: ASST degli Spedali Civili di Brescia
city: Isernia
country: Italy
facility: IRCCS Neuromed Istituto Neurologico Mediterraneo
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Roma
country: Italy
facility: Fondazione Policlinico Uni Campus Bio-Medico di Roma
city: Roma
country: Italy
facility: Policlinico Universitario Agostino Gemelli
city: Roma
country: Italy
facility: AOU Policlinico Umberto I
city: Salerno
country: Italy
facility: Azienda Ospedaliera Universitaria OO. RR. S.
city: Torino
country: Italy
facility: Dipartimento di Neuroscienze Rita Levi Montalcini
city: Tricase
country: Italy
facility: Azienda Ospedaliera Card. G. Panico
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Eunpyeong St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
city: Monterrey
country: Mexico
facility: Iecsi S.C.
state: N.L
city: Ciudad de Mexico
country: Mexico
facility: Mexico Centre for Clinical Research S.A de C.V
city: Coahuila
country: Mexico
facility: Hospital Universitario Dr. Gonzalo Valdes Valdes
city: Estado De Mexico
country: Mexico
facility: Clinical Research Institute S.C
city: San Luis Potosí
country: Mexico
facility: BIND Investigaciones S.C.
city: Sinaloa
country: Mexico
facility: Neurociencias Estudios Clinicos
city: Sinaloa
country: Mexico
facility: Centro para el Des de la Med y de Asist Med Esp SC
city: Belgrade
country: Serbia
facility: Clinical Hosp Center Dr Dragisa Misovic Dedinje
city: Belgrade
country: Serbia
facility: Clinical. Hospital Center Zvezdara
city: Belgrade
country: Serbia
facility: Institute of Mental Health
city: Kovin
country: Serbia
facility: Spl. Hosp. for Psychiatric Diseases Kovin
city: Kragujevac
country: Serbia
facility: Janjic University Clinical Center Kragujevac
city: Kragujevac
country: Serbia
facility: Jovanovic University Clinical Centre of Kragujevac
city: Kragujevac
country: Serbia
facility: University Clinical Center Kragujevac
city: Niš
country: Serbia
facility: University Clinical Center Nis
city: Novi Kneževac
country: Serbia
facility: Spl. Hosp. for Psychiatric Diseases Sveti Vracevi
city: Sombor
country: Serbia
facility: Gen. Hosp. Dr Radivoj Simonovic
city: Valjevo
country: Serbia
facility: General Hospital Valjevo
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Zamora
country: Spain
facility: Hospital Provincial de Zamora
city: Kaohsiung City
country: Taiwan
facility: E-DA Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: New Taipei City
country: Taiwan
facility: Taipei Medical University-Shuang Ho Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References: