Clinical trial • Phase III • Neurology
ACP-204 TARTRATE for Dementia with Lewy bodies|Lewy body Dementia psychosis (LBDP)
Phase III trial of ACP-204 TARTRATE for Dementia with Lewy bodies|Lewy body Dementia psychosis (LBDP). open-label. 77 participants.
Overview
- Trial Therapeutic Area
- Neurology
- Trial Disease
- Dementia with Lewy bodies|Lewy body Dementia psychosis (LBDP)
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 14-07-2025
- First CTIS Authorization Date
- 03-11-2025
Trial design
open-label Phase III trial in Czechia, France, Italy and others.
- Open Label
- Yes
- Target Sample Size
- 77
- Trial Duration For Participant
- 364
Eligibility
Recruits 77 Subjects have Lewy body dementia psychosis and may lack capacity. If a subject is judged not competent to provide informed consent, the subject’s legally authorised representative (LAR) or the study partner/caregiver (where local regulations allow) must provide written informed consent, and the subject must provide written assent if capable. Caregiver/study partner involvement is required (e.g., to complete visits). Vulnerable population justification documents are provided in the dossier..
- Pregnancy Exclusion
- If the subject is a female, she must be of nonchildbearing potential
- Vulnerable Population
- Subjects have Lewy body dementia psychosis and may lack capacity. If a subject is judged not competent to provide informed consent, the subject’s legally authorised representative (LAR) or the study partner/caregiver (where local regulations allow) must provide written informed consent, and the subject must provide written assent if capable. Caregiver/study partner involvement is required (e.g., to complete visits). Vulnerable population justification documents are provided in the dossier.
Inclusion criteria
- {"criterion_text":"- The subject may benefit from long-term therapy with open-label ACP-204 treatment in the judgment of the Investigator\n- Subject has completed Visit 6 (EOT) of the antecedent ACP-204-012 study and did not have an early discontinuation from the antecedent study\n- Can complete all study visits with a study partner/caregiver\n- Can understand the nature of the study and protocol requirements and provide written informed consent. If the subject is deemed not competent to provide informed consent, the following requirements for consent must be met: a. The subject’s LAR (or study partner/caregiver, if local regulations allow) must provide written informed consent. b. The subject must provide written (if capable) informed assent per local regulations.\n- If the subject is a female, she must be of nonchildbearing potential\n- If the subject is male, he must agree to the following during the study intervention period and for at least 90 days after the last dose of study drug: a. Refrain from donating sperm, AND b. Either be abstinent from sexual intercourse where pregnancy can occur (abstinent on a long-term and persistent basis) and agree to remain abstinent OR Use a condom and subject's female partner (if of childbearing potential and not pregnant) must use an additional contraceptive method"}
Exclusion criteria
- {"criterion_text":"- Is judged by the Investigator or the Medical Monitor to be inappropriate for the study for any reason\n- Is in hospice, is receiving end-of-life palliative care, or is bedridden\n- Has a heart rate <50 beats per minute, as measured by vital signs at Baseline (EOT visit of the antecedent study). If bradycardia is secondary to iatrogenic or treatable causes and these causes are addressed, a heart rate assessment can be repeated.\n- Has a BMI <18.5 kg/m or known unintentional weight loss ≥7% of body weight over past 6 months\n- Has a clinically significant laboratory abnormality in the antecedent ACP-204-012 study, excepting at ACP-204-012 EOT, that in the judgment of the Investigator or Medical Monitor, will either: a. jeopardize the safe participation of the subject in this study; OR b. interfere with the conduct or interpretation of safety or efficacy evaluations in the study\n- Is actively suicidal at Visit 1 (Baseline, EOT visit of the antecedent study)\n- Has a neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical or mental disorder, including cancer or malignancies that, in the judgment of the Investigator, would increase the risk associated with taking study medication or significantly interfere with the conduct or interpretation of the study\n- Requires treatment with a medication or other substance that is prohibited by the protocol or will be used in a way that violates a use restriction"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Treatment-emergent adverse events (TEAEs)","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 77
- Recruitment Window Months
- 26
- Consent Approach
- Participants capable of consent must provide written informed consent. If the subject is judged not competent to provide informed consent, the subject’s legally authorised representative (LAR) or study partner/caregiver (if local regulations allow) must provide written informed consent, and the subject must provide written (if capable) informed assent per local regulations. Study documents include Main ICF and caregiver ICFs and pregnant-partner ICFs; ICF translations/versions are provided for Czech, French, Italian, Bulgarian and English in the submitted documents.
Methods
- Recruitment is limited to subjects who have completed Visit 6 (EOT) of the antecedent ACP-204-012 study and did not have an early discontinuation from the antecedent study (i.e., rollover/extension from prior trial).
Geography
- Total Number Of Sites
- 29
- Total Number Of Participants
- 49
Czechia
- Earliest CTIS Part Ii Submission Date
- 03-10-2025
- Latest Decision Or Authorization Date
- 03-11-2025
- Processing Time Days
- 31
- Number Of Sites
- 5
- Number Of Participants
- 10
Sites
- 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
- Neurohk s.r.o.
- Department Name
- ---
- Contact Person Name
- Martin Valis
- Contact Person Email
- valismar@seznam.cz
- Site Name
- Neuropsychiatrie s.r.o.
- Department Name
- ---
- Contact Person Name
- Jakub Hort
- Contact Person Email
- jakub.hort@gmail.com
- Site Name
- Vseobecna Fakultni Nemocnice V Praze
- Department Name
- Neurologická klinika
- Contact Person Name
- Hana Brozova
- Contact Person Email
- Hana.Brozova@lf1.cuni.cz
- Site Name
- Vestra Clinics s.r.o.
- Department Name
- ----
- Contact Person Name
- Ladislav Pazdera
- Contact Person Email
- pazdera@vestraclinics.org
France
- Earliest CTIS Part Ii Submission Date
- 24-09-2025
- Latest Decision Or Authorization Date
- 10-11-2025
- Processing Time Days
- 47
- Number Of Sites
- 10
- Number Of Participants
- 13
Sites
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Gerontopole
- Contact Person Name
- Julien DELRIEU
- Contact Person Email
- delrieu.j@chu-toulouse.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Geriatrics
- Contact Person Name
- Sophie DAUTRICOURT
- Contact Person Email
- sophie.dautricourt@chu-lyon.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- CMRR
- Contact Person Name
- Thibaud LEBOUVIER
- Contact Person Email
- thibaud.lebouvier@chu-lille.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- CMRR
- Contact Person Name
- Claire PAQUET
- Contact Person Email
- claire.paquet@aphp.fr
- Site Name
- CHRU De Nancy
- Department Name
- Geriatry
- Contact Person Name
- Laure JOLY
- Contact Person Email
- l.joly@chru-nancy.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Geriatrics
- Contact Person Name
- Hermine LENOIR
- Contact Person Email
- hermine.lenoir@aphp.fr
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- CMRR
- Contact Person Name
- Alix RAVIER
- Contact Person Email
- alix.ravier@chru-strasbourg.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Neurology
- Contact Person Name
- Hélène MOLLION
- Contact Person Email
- helene.mollion@chu-lyon.fr
- Site Name
- Centre Hospitalier Regional Universitaire De Tours
- Department Name
- Memory Clinic
- Contact Person Name
- Thomas DESMIDT
- Contact Person Email
- t.desmidt@chu-tours.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Neurology
- Contact Person Name
- Jeremie PARIENTE
- Contact Person Email
- jeremie.pariente@inserm.fr
Italy
- Earliest CTIS Part Ii Submission Date
- 01-10-2025
- Latest Decision Or Authorization Date
- 07-11-2025
- Processing Time Days
- 37
- Number Of Sites
- 7
- Number Of Participants
- 11
Sites
- Site Name
- Azienda Ospedaliero-Universitaria Policlinico Umberto I
- Department Name
- Neurologia
- Contact Person Name
- Giuseppe Bruno
- Contact Person Email
- giuseppe.bruno@uniroma1.it
- Site Name
- Universita' Campus Bio-medico Di Roma
- Department Name
- Neurologia
- Contact Person Name
- Vincenzo Di Lazzaro
- Contact Person Email
- v.dilazzaro@policlinicocampus.it
- Site Name
- Azienda Ospedaliera Universitaria San Giovanni Di Dio E Ruggi d'Aragona
- Department Name
- Neurologia
- Contact Person Name
- Paolo Barone
- Contact Person Email
- pbarone@unisa.it
- Site Name
- Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
- Department Name
- Neurologia
- Contact Person Name
- Alessandro Tessitore
- Contact Person Email
- alessandro.tessitore@unicampania.it
- Site Name
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Department Name
- Neurologia
- Contact Person Name
- Alessandro Padovani
- Contact Person Email
- alessandro.padovani@unibs.it
- Site Name
- Pia Fondazione Di Culto E Religione Card G Panico
- Department Name
- Neurologia
- Contact Person Name
- Giancarlo Logroscino
- Contact Person Email
- giancarlo.logroscino@uniba.it
- Site Name
- Azienda Ospedaliera Universitaria Policlinico Umberto I (additional listed sites are part of this country block)
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 15-10-2025
- Latest Decision Or Authorization Date
- 23-04-2026
- Processing Time Days
- 190
- Number Of Sites
- 7
- Number Of Participants
- 15
Sites
- Site Name
- Alexandrovska University Hospital
- Department Name
- Department for Neurodegenerative and Immune inflammatory Diseases of CNS and neuroinfections
- Contact Person Name
- Latchezar Traykov
- Contact Person Email
- traykov_l@yahoo.fr
- 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
- 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
- Children's Health Medical Center EOOD
- Contact Person Name
- Lora Drianovska-Tzoneva
- Contact Person Email
- ltzoneva@abv.bg
- Site Name
- Diagnostics-Consultancy Center Mladost M Varna OOD
- Contact Person Name
- Hristo Kozhuharov
- Contact Person Email
- christokojuharov@abv.bg
- Site Name
- Medical Center Saint Naum EOOD
- Contact Person Name
- Assen Karadaliev
- Contact Person Email
- karadliev@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
Sponsor
Primary sponsor
- Full Name
- Acadia Pharmaceuticals Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- IQVIA Limited
- Responsibilities
- sponsorDuties codes: 1,12,13,2,5,6,7
- Name
- Signant Health Global LLC
- Responsibilities
- eCOA, scales and rater training; 'Scales, Rater training, eCOA devices for scale administration, scale acquisition' (as provided)
- Name
- Primevigilance Limited
- Responsibilities
- sponsorDuties codes: 8
- Name
- Suvoda LLC
- Responsibilities
- sponsorDuties codes: 3
Third parties
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: 1,12,13,2,5,6,7","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"code 15: Scales, Rater training, eCOA devices for scale administration, scale acquisition","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Primevigilance Limited","duties_or_roles":"sponsorDuties codes: 8","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"sponsorDuties codes: 3","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Belgium","full_name":"MEDPACE LABORATORIES","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Germany","full_name":"Catalent Germany Schorndorf GmbH","duties_or_roles":"sponsorDuties codes: 14","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- ACP-204 (capsule) - formulation A
- Active Substance
- ACP-204 TARTRATE
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- ORAL USE
- Dose Levels
- 30 mg (max daily dose 30 mg reported)
- Maximum Dose
- 30 mg
- Investigational Product Name
- ACP-204 (capsule) - formulation B
- Active Substance
- ACP-204 TARTRATE
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- ORAL USE
- Dose Levels
- 60 mg (max daily dose 60 mg reported)
- Maximum Dose
- 60 mg
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