Clinical trial • Phase II/III • Neurology
ACP-204 TARTRATE for Alzheimer's disease psychosis
Phase II/III trial of ACP-204 TARTRATE for Alzheimer's disease psychosis.
Overview
- Trial Therapeutic Area
- Neurology
- Trial Disease
- Alzheimer's disease psychosis
- Trial Stage
- Phase II/III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 08-02-2024
- First CTIS Authorization Date
- 31-05-2024
Trial design
Randomised, acp-204 60 mg - administration once daily at approximately the same time of day, with or without food; acp-204 30 mg - administration once daily at approximately the same time of day, with or without food; placebo to match acp-204 - administration once daily at approximately the same time of day, with or without food-controlled Phase II/III trial in Spain, Czechia, Bulgaria and others.
- Randomised
- Yes
- Comparator
- ACP-204 60 mg - Administration once daily at approximately the same time of day, with or without food; ACP-204 30 mg - Administration once daily at approximately the same time of day, with or without food; Placebo to match ACP-204 - Administration once daily at approximately the same time of day, with or without food
- Target Sample Size
- 792
- Trial Duration For Participant
- 114
Eligibility
Recruits 792 Participants are adults with Alzheimer disease psychosis (cognitive impairment). The trial selects vulnerable subjects (isVulnerablePopulationSelected = true). Consent processes include subject informed consent forms and separate caregiver/study partner informed consent materials (Caregiver ICF). eConsent materials and participant-facing information are provided. The study requires a designated study partner/caregiver to complete study visits, and caregiver involvement is documented (Caregiver ICF, study partner documents). Consent and information materials are available in multiple language versions (English, Bulgarian, Spanish, French, Italian, Czech) as shown in submitted ICF and eConsent documents..
- Vulnerable Population
- Participants are adults with Alzheimer disease psychosis (cognitive impairment). The trial selects vulnerable subjects (isVulnerablePopulationSelected = true). Consent processes include subject informed consent forms and separate caregiver/study partner informed consent materials (Caregiver ICF). eConsent materials and participant-facing information are provided. The study requires a designated study partner/caregiver to complete study visits, and caregiver involvement is documented (Caregiver ICF, study partner documents). Consent and information materials are available in multiple language versions (English, Bulgarian, Spanish, French, Italian, Czech) as shown in submitted ICF and eConsent documents.
Inclusion criteria
- {"criterion_text":"- Is male or female and ≥55 and <85 years of age living in the community or in an institutionalized setting"}
- {"criterion_text":"- Able to complete all study visits with a study partner/caregiver"}
- {"criterion_text":"- Must be on a stable dose of cholinesterase inhibitor or memantine, if applicable"}
- {"criterion_text":"- Meets clinical criteria for possible or probable AD based on the 2011 National Institute on Aging-Alzheimer Association (NIA-AA) criteria"}
- {"criterion_text":"- Meets the revised criteria for psychosis in major or mild neurocognitive disorder established by the International Psychogeriatrics Association (IPA)"}
- {"criterion_text":"- 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"}
- {"criterion_text":"- Has a prior magnetic resonance imaging or computed tomography scan of the brain that is consistent with the diagnosis of AD"}
- {"criterion_text":"- MMSE score ≥6 and ≤24"}
- {"criterion_text":"- Psychotic symptoms for at least 2 months"}
- {"criterion_text":"- Lives in a stable place of residence and there are no plans to change living arrangements"}
- {"criterion_text":"- Has a designated study partner/caregiver"}
Exclusion criteria
- {"criterion_text":"- Requires treatment with a medication prohibited by the protocol"}
- {"criterion_text":"- Is in hospice and receiving end-of-life palliative care, or has become bedridden"}
- {"criterion_text":"- Requires skilled nursing care"}
- {"criterion_text":"- Psychotic symptoms that are primarily attributable to delirium, substance abuse, or a medical or psychiatric condition other than dementia"}
- {"criterion_text":"- Known history of cerebral amyloid angiopathy, epilepsy, central nervous system neoplasm, or unexplained syncope"}
- {"criterion_text":"- Atrial fibrillation"}
- {"criterion_text":"- Symptomatic orthostatic hypotension"}
- {"criterion_text":"- Protocol-defined exclusionary clinical laboratory findings"}
- {"criterion_text":"- Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met."}
Endpoints
Primary endpoints
- {"endpoint_text":"- From baseline to Week 6: 1. Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions subscales (SAPS-H+D) total score change from baseline.","definition_or_measurement_approach":"Change from baseline to Week 6 in the SAPS-H+D total score (Scale for the Assessment of Positive Symptoms - Hallucinations and Delusions subscales)."}
Secondary endpoints
- {"endpoint_text":"- From baseline to Week 6: Clinical Global Impression–Severity in the ADP context (CGI-S-ADP) total score change from baseline","definition_or_measurement_approach":"Change from baseline to Week 6 in the CGI-S-ADP total score (Clinical Global Impression–Severity in the ADP context)."}
Recruitment
- Registry Or Advocacy Recruitment
- True - Patient Advocacy Group (unnamed, referenced via 'Patient Advocacy Group Letter' recruitment document)
- Digital Remote Recruitment
- True - Includes online advertising scripts, online screening website/script, eConsent participant-facing landing page and eConsent screenshots; used to reach patients and care partners remotely across participating countries.
- Planned Sample Size
- 792
- Recruitment Window Months
- 50
- Consent Approach
- Informed consent is obtained using a Main ICF for participants plus separate Caregiver ICF and Pregnant Partner ICF where applicable. eConsent materials (participant-facing landing page, screenshots, security/privacy guides) are available. A designated study partner/caregiver is required to accompany participants and is involved in consent/assessments (Caregiver ICF). Consent documents and participant materials are provided in multiple languages (English, Bulgarian, Spanish, French, Italian, Czech).
Methods
- Online advertising: scripts and online screening website materials (target: patients with Alzheimer’s disease psychosis and their care partners); country-specific online materials provided.
- Patient letter and patient ID card: direct mail or clinic distribution to potential participants and care partners.
- Physician referral letters: materials to support recruitment via clinicians/neurology/psychiatry practices.
- Print flyers and recruiting brochures: patient and care partner brochures and flyers for clinic or community distribution.
- Advocacy / Patient Advocacy Group engagement: Patient Advocacy Group letter to engage advocacy organizations.
- eConsent and participant-facing landing pages: electronic consent materials and eConsent screenshots to support remote or digital consent.
- Welcome letters and travel/reimbursement support materials (Clincierge, Pay Portal Guide) to facilitate participation.
Geography
- Total Number Of Sites
- 46
- Total Number Of Participants
- 282
Spain
- Earliest CTIS Part Ii Submission Date
- 06-05-2024
- Latest Decision Or Authorization Date
- 03-06-2024
- Processing Time Days
- 28
- Number Of Sites
- 4
- Number Of Participants
- 20
Sites
- Site Name
- Hospital Universitario Regional De Malaga
- Department Name
- Neurology
- Contact Person Name
- Pedro Jesus Serrano Castro
- Contact Person Email
- estudios.clinicos@ibima.eu
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Neurology
- Contact Person Name
- Felix Vinuela Fernandez
- Contact Person Email
- fvinuelaf@gmail.com
- Site Name
- Complejo Asistencial De Zamora Hospital Provincial De Zamora
- Department Name
- Neurology
- Contact Person Name
- Manuel Angel Franco Martin
- Contact Person Email
- mfrancom@saludcastillayleon.es
- Site Name
- Hospital Germans Trias I Pujol
- Department Name
- Neurology
- Contact Person Name
- Pau Pastor Muñoz
- Contact Person Email
- paupastorm.germanstrias@gencat.cat
Czechia
- Earliest CTIS Part Ii Submission Date
- 03-05-2024
- Latest Decision Or Authorization Date
- 03-06-2024
- Processing Time Days
- 31
- Number Of Sites
- 8
- Number Of Participants
- 66
Sites
- Site Name
- Brain-Soultherapy s.r.o.
- Contact Person Name
- Klaudia Vodickova Borzova
- Contact Person Email
- cborzova@seznam.cz
- Site Name
- Ad71 s.r.o.
- Contact Person Name
- Ilona Divacka
- Contact Person Email
- info@vodopad.cz
- Site Name
- Clintrial s.r.o.
- Contact Person Name
- Zdenek Solle
- Contact Person Email
- zdenek.solle@clintrial.cz
- Site Name
- INEP medical s.r.o.
- Contact Person Name
- Alexander Nawka
- Contact Person Email
- nawka@inep.cz
- Site Name
- Neurohk s.r.o.
- Contact Person Name
- Martin Valis
- Contact Person Email
- valismar@seznam.cz
- Site Name
- Fakultni Nemocnice U Sv Anny V Brne
- Department Name
- I.Neurologická klinika
- Contact Person Name
- Lenka Krajcovicova
- Contact Person Email
- lenka.krajcovicova@fnusa.cz
- Site Name
- Forbeli s.r.o.
- Contact Person Name
- Michal Bajacek
- Contact Person Email
- mbajacek@yahoo.co.uk
- Site Name
- Vestra Clinics s.r.o.
- Contact Person Name
- Ladislav Pazdera
- Contact Person Email
- pazdera@vestraclinics.org
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 04-04-2024
- Latest Decision Or Authorization Date
- 04-06-2024
- Processing Time Days
- 61
- Number Of Sites
- 12
- Number Of Participants
- 82
Sites
- Site Name
- University Multiprofile Hospital For Active Treatment Saint Georgi EAD
- Department Name
- Clinic of Psychiatry
- Contact Person Name
- Andriana Kakanakova
- Contact Person Email
- andriana_kakanakova@hotmail.com
- Site Name
- Diagnostic And Consultation Centre St.Vrach And St.St. Kuzma And Damian OOD
- Contact Person Name
- Petya Dimitrova
- Contact Person Email
- drdimitrova@abv.bg
- Site Name
- Medical Center Hera EOOD
- Contact Person Name
- Spiridon Spiridonov
- Contact Person Email
- spiridon.aleksiev@gmail.com
- Site Name
- Center For Mental Health Prof. N. Shipkovenski EOOD
- Contact Person Name
- Ana Popova
- Contact Person Email
- dr.anapopova@gmail.com
- Site Name
- Medical Center Lifemed EOOD
- Contact Person Name
- Rozaliya Rangelova
- Contact Person Email
- rrangelova80@gmail.com
- Site Name
- Higya–DCC OOD
- Contact Person Name
- Dora Atanasova
- Contact Person Email
- dora_pazardjik@abv.bg
- Site Name
- Dr. Ivo Natsov Outpatient Clinic For Individual Practice For Specialized Medical Care In Psychiatry ET
- Contact Person Name
- Ivo Natsov
- Contact Person Email
- ivo_nacov@abv.bg
- Site Name
- Medical Center Intermedica Ltd.
- Contact Person Name
- Toni Donchev
- Contact Person Email
- tonyd@abv.bg
- Site Name
- Medical Center Spectar Plovdiv EOOD
- Contact Person Name
- Nikolay Popov
- Contact Person Email
- nikpopov@abv.bg
- Site Name
- Alexandrovska University Hospital
- Department Name
- Clinic of Psychiatry
- Contact Person Name
- Georgi Onchev
- Contact Person Email
- georgi.onchev@gmail.com
- Site Name
- Medical Center Medconsult Pleven OOD
- Contact Person Name
- Mariya Alexandrova-Stoycheva
- Contact Person Email
- doc_maria_aleksandrova@abv.bg
- Site Name
- Alexandrovska University Hospital
- Department Name
- Clinic of neurological disorders
- Contact Person Name
- Latchezar Traykov
- Contact Person Email
- traykov_l@yahoo.fr
Italy
- Earliest CTIS Part Ii Submission Date
- 22-02-2024
- Latest Decision Or Authorization Date
- 31-05-2024
- Processing Time Days
- 99
- Number Of Sites
- 10
- Number Of Participants
- 62
Sites
- Site Name
- Azienda Ospedaliero-Universitaria Policlinico Umberto I
- Department Name
- Neurology
- Contact Person Name
- Giuseppe Bruno
- Contact Person Email
- giuseppe.bruno@uniroma1.it
- Site Name
- Istituto Neurologico Mediterraneo Neuromed S.p.A.
- Department Name
- Neurology
- Contact Person Name
- Diego Centonze
- Contact Person Email
- centonze@uniroma2.it
- Site Name
- Azienda Ospedaliera Universitaria San Giovanni Di Dio E Ruggi d'Aragona
- Department Name
- Neurology
- Contact Person Name
- Paolo Barone
- Contact Person Email
- pbarone@unisa.it
- Site Name
- Universita' Campus Bio-medico Di Roma
- Department Name
- Neurology
- Contact Person Name
- Vincenzo Di Lazzaro
- Contact Person Email
- v.dilazzaro@policlinicocampus.it
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- Neurology
- Contact Person Name
- Massimo Filippi
- Contact Person Email
- filippi.massimo@hsr.it
- Site Name
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Department Name
- Neurology
- Contact Person Name
- Alessandro Padovani
- Contact Person Email
- padovanineurologia@gmail.com
- Site Name
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
- Department Name
- Neurology
- Contact Person Name
- Innocenzo Rainero
- Contact Person Email
- innocenzo.rainero@unito.it
- Site Name
- Pia Fondazione Di Culto E Religione Card G Panico
- Department Name
- Neurology
- Contact Person Name
- Daniele Urso
- Contact Person Email
- d.urso@piafondazionepanico.it
- Site Name
- Fondazione Istituto G. Giglio Di Cafalu
- Department Name
- U.O Neurologia
- Contact Person Name
- Luigi Grimaldi
- Contact Person Email
- luigi.grimaldi@hsrgiglio.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- Neurology
- Contact Person Name
- Davide Quaranta
- Contact Person Email
- davide.quaranta@policlinicogemelli.it
France
- Earliest CTIS Part Ii Submission Date
- 03-05-2024
- Latest Decision Or Authorization Date
- 03-06-2024
- Processing Time Days
- 31
- Number Of Sites
- 12
- Number Of Participants
- 52
Sites
- Site Name
- Centre Hospitalier Pasteur
- Department Name
- Centre pour Personnes Âgées
- Contact Person Name
- Pierre ANTHONY
- Contact Person Email
- pierre.anthony@ch-colmar.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Centre de Recherche Clinique
- Contact Person Name
- Antoine GARNIER-CRUSSARD
- Contact Person Email
- antoine.garnier-crussard@chu-lyon.fr
- Site Name
- Centre Hospitalier Universitaire De Dijon
- Department Name
- Centre Mémoire Ressources et Recherche
- Contact Person Name
- Sophie MOHR
- Contact Person Email
- sophie.mohr@chu-dijon.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Gérontopôle Centre de Recherche Clinique
- Contact Person Name
- Maria SOTO MARTIN
- Contact Person Email
- soto-martin.me@chu-toulouse.fr
- Site Name
- Centre Hospitalier Regional Universitaire De Tours
- Department Name
- Centre Mémoire Ressources et Recherche (CMRR)
- Contact Person Name
- Thomas DESMIDT
- Contact Person Email
- t.desmidt@chu-tours.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Centre de Neurologie Cognitive
- Contact Person Name
- Emmanuel COGNAT
- Contact Person Email
- emmanuel.cognat@aphp.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Pôle de gériatrie
- Contact Person Name
- Hermine LENOIR
- Contact Person Email
- hermine.lenoir@aphp.fr
- Site Name
- Centre Hospitalier Universitaire Rouen
- Department Name
- Service de Neurologie
- Contact Person Name
- David WALLON
- Contact Person Email
- david.wallon@chu-rouen.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Service de Neurologie
- Contact Person Name
- Jérémie PARIENTE
- Contact Person Email
- jeremie.pariente@inserm.fr
- Site Name
- CHRU De Nancy
- Department Name
- Département Gériatrie Aigue
- Contact Person Name
- Laure JOLY
- Contact Person Email
- l.joly@chru-nancy.fr
- Site Name
- Centre Hospitalier Et Universitaire De Limoges
- Department Name
- Service de Médecine Gériatrique
- Contact Person Name
- Achille TCHALLA
- Contact Person Email
- achille.tchalla@chu-limoges.fr
- Site Name
- Hospital Pierre Wertheimer
- Department Name
- Service Neurologie
- Contact Person Name
- Hélène MOLLION
- Contact Person Email
- helene.mollion@chu-lyon.fr
Sponsor
Primary sponsor
- Full Name
- Acadia Pharmaceuticals Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Parexel International Corp.
- Responsibilities
- case processing
- Name
- IQVIA Limited
- Name
- Signant Health Global LLC
- Responsibilities
- Scales, Rater training, eCOA devices for scale administration, scale acquisition
- Name
- Icon Laboratory Services Inc.
Third parties
- {"country":"United States","full_name":"Gray Consulting Inc.","duties_or_roles":"travel and reimbursement vendor","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"Scales, Rater training, eCOA devices for scale administration, scale acquisition","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"case processing","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Icon Laboratory Services Inc.","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
Investigational products
- Investigational Product Name
- ACP-204
- Active Substance
- ACP-204 TARTRATE
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL
- Authorisation Status
- MIA: DE_BW_01_MIA_2024_0081
- Starting Dose
- 30 mg
- Dose Levels
- 30 mg | 60 mg
- Frequency
- Administration once daily at approximately the same time of day, with or without food
- Maximum Dose
- 60 mg
- Investigational Product Name
- Placebo to match ACP-204
- Modality
- Other
- Frequency
- Administration once daily at approximately the same time of day, with or without food
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