Clinical trial • Phase II • Neurology

ACP-204 TARTRATE for Lewy body dementia psychosis | Dementia with Lewy bodies

Phase II trial of ACP-204 TARTRATE for Lewy body dementia psychosis | Dementia with Lewy bodies.

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Lewy body dementia psychosis | Dementia with Lewy bodies
Trial Stage
Phase II
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
07-07-2025
First CTIS Authorization Date
29-10-2025

Trial design

Randomised, placebo for acp-204 capsules (matching placebo arm); comparator is placebo versus acp-204 30 mg and acp-204 60 mg (dose and route: 30 mg and 60 mg oral capsules; schedule not specified in provided data).-controlled Phase II trial in France, Italy, Bulgaria and others.

Randomised
Yes
Comparator
Placebo for ACP-204 capsules (matching placebo arm); comparator is placebo versus ACP-204 30 mg and ACP-204 60 mg (dose and route: 30 mg and 60 mg oral capsules; schedule not specified in provided data).
Target Sample Size
103
Trial Duration For Participant
180

Eligibility

Recruits 103 The trial includes vulnerable adults with neurocognitive disorders/dementia. If a subject is deemed not competent to provide informed consent, the subject’s legally authorised representative (LAR) or study partner/caregiver (if allowed locally) must provide written informed consent and the subject must provide written assent if capable. Caregiver-specific informed consent forms are provided..

Vulnerable Population
The trial includes vulnerable adults with neurocognitive disorders/dementia. If a subject is deemed not competent to provide informed consent, the subject’s legally authorised representative (LAR) or study partner/caregiver (if allowed locally) must provide written informed consent and the subject must provide written assent if capable. Caregiver-specific informed consent forms are provided.

Inclusion criteria

  • {"criterion_text":"- Male or female ≥55 years to <85 years of age at the Screening visit living in the community or, if permitted by local regulations, in an institutionalized setting\n- Can 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- Meets either the clinical criteria for Parkinson’s disease with dementia as defined by the Movement Disorder Society’s Task Force or the revised clinical criteria for probable dementia with Lewy bodies (DLB) by consensus criteria (Fourth consensus report of the DLB Consortium)\n- Meets the revised criteria for psychosis in major or mild neurocognitive disorder established by the International Psychogeriatrics Association"}

Exclusion criteria

  • {"criterion_text":"- Is in hospice, is receiving end-of-life palliative care, or is bedridden\n- Has psychotic symptoms that are primarily attributable to delirium, substance abuse, or a medical or psychiatric condition (e.g., schizophrenia, bipolar disorder, delusional disorder) other than dementia\n- Is actively suicidal at Visit 1 (Screening) or Visit 2 (Baseline)\n- Has a history or current evidence of a serious and/or significant unstable cardiovascular, respiratory, endocrine, gastrointestinal, renal, hepatic, hematologic, immunologic, genitourinary, psychiatric or neurologic (including stroke, chronic seizures, or clinically significant head injury) abnormality or disease or other medical disorder, including cancer or malignancies, that could interfere with subject’s ability to complete the study or comply with study procedures\n- Has other clinically significant CNS abnormalities that are most likely contributing to the dementia or findings on MRI or CT"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Change from Baseline in SAPS-LBDP total score at Week 6","definition_or_measurement_approach":"Change from baseline at Week 6 measured by the Scale for the Assessment of Positive Symptoms– Lewy Body Dementia Psychosis (SAPS-LBDP), a modified 9-item scale comprising SAPS Hallucinations and Delusions subscales items."}

Recruitment

Registry Or Advocacy Recruitment
True - Patient Advocacy Group(s) (document: K2_Patient Advocacy Group Letter_san / K2_Patient Advocacy Group Letter)
Digital Remote Recruitment
True - digital/remote methods include online advertising scripts, online screening scripts and online screening materials, online advertising images and online recruitment materials in multiple languages (English, French, Italian, Bulgarian, Czech).
Planned Sample Size
103
Recruitment Window Months
19
Consent Approach
Informed consent is obtained in writing. If a subject is not competent to provide consent, the subject’s legally authorised representative (LAR) or study partner/caregiver (where allowed locally) must provide written informed consent; the subject must provide written assent if capable. Caregiver ICFs and main ICFs are available; documents exist in multiple languages (English, French, Italian, Bulgarian, Czech) and caregiver-specific consent materials are provided.

Methods

  • Online advertising (documents: K2_Online Advertising Script, K2_Online Advertising Script_english) - channel: online; target audience: patients and caregivers; multiple language versions provided.
  • Online screening scripts (documents: K2_Online Screening Script) - channel: online pre-screening; target audience: potential participants.
  • Print materials: Print flyers, recruiting brochures, patient letters (documents: K2_Print Flyer, K2_Recruiting Brochure, K2_Patient Letter) - channel: print/mail/in-clinic; target audience: patients and caregivers.
  • Dr-to-patient letters / Doctor referral letters (documents: K2_Dr to Patient Letter) - channel: clinician referral; target audience: clinicians and their patients.
  • Consent flip charts and patient-facing materials (documents: K2_Consent Flip Chart, L1_Main ICF, L2_Caregiver ICF) used in clinic to support informed consent discussions.

Geography

Total Number Of Sites
28
Total Number Of Participants
77

France

Earliest CTIS Part Ii Submission Date
30-09-2025
Latest Decision Or Authorization Date
11-02-2026
Processing Time Days
134
Number Of Sites
10
Number Of Participants
21

Sites

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
Assistance Publique Hopitaux De Paris
Department Name
CMRR
Contact Person Name
Claire PAQUET
Contact Person Email
claire.paquet@aphp.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Memory Resource and research Center
Contact Person Name
Thibaud LEBOUVIER
Contact Person Email
thibaud.lebouvier@chu-lille.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
Les Hopitaux Universitaires De Strasbourg
Department Name
CMRR
Contact Person Name
Alix RAVIER
Contact Person Email
alix.ravier@chru-strasbourg.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
CHRU De Nancy
Department Name
Geriatry
Contact Person Name
Laure JOLY
Contact Person Email
l.joly@chru-nancy.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Neurology
Contact Person Name
Jeremie PARIENTE
Contact Person Email
jeremie.pariente@inserm.fr
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

Italy

Earliest CTIS Part Ii Submission Date
24-09-2025
Latest Decision Or Authorization Date
12-02-2026
Processing Time Days
141
Number Of Sites
6
Number Of Participants
17

Sites

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 Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
Neurologia
Contact Person Name
Alessandro Padovani
Contact Person Email
padovanineurologia@gmail.com
Site Name
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name
Neurologia
Contact Person Name
Alessandro Tessitore
Site Name
Universita' Campus Bio-medico Di Roma
Department Name
Neurologia
Contact Person Name
Vincenzo Di Lazzaro
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
Pia Fondazione Di Culto E Religione Card G Panico
Department Name
Neurologia
Contact Person Name
Giancarlo Logroscino
Contact Person Email
giancarlo.logroscino@uniba.it

Bulgaria

Earliest CTIS Part Ii Submission Date
15-10-2025
Latest Decision Or Authorization Date
19-02-2026
Processing Time Days
127
Number Of Sites
7
Number Of Participants
24

Sites

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
Children's Health Medical Center EOOD
Contact Person Name
Lora Drianovska-Tzoneva
Contact Person Email
Itzoneva@abv.bg
Site Name
Medical Center Saint Naum EOOD
Contact Person Name
Assen Karadaliev
Contact Person Email
karadliev@hotmail.com
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
Diagnostics-Consultancy Center Mladost M Varna OOD
Contact Person Name
Hristo Kozhuharov
Contact Person Email
christokojuharov@abv.bg
Site Name
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Department Name
Clinic of Psychiatry
Contact Person Name
Andriana Kakanakova
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

Czechia

Earliest CTIS Part Ii Submission Date
01-10-2025
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
201
Number Of Sites
5
Number Of Participants
15

Sites

Site Name
Vestra Clinics s.r.o.
Department Name
---
Contact Person Name
Ladislav Pazdera
Contact Person Email
pazdera@vestraclinics.org
Site Name
Neurohk s.r.o.
Department Name
---
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
Vseobecna Fakultni Nemocnice V Praze
Department Name
Neurologická klinika
Contact Person Name
Hana Brozova
Contact Person Email
hana.brozova@lf1.cuni.cz
Site Name
Neuropsychiatrie s.r.o.
Department Name
---
Contact Person Name
Jakub Hort
Contact Person Email
jakub.hort@gmail.com

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
codes: 1, 12, 13, 2, 5, 6, 7
Name
Suvoda LLC
Responsibilities
codes: 3
Name
QPS LLC
Responsibilities
codes: 4
Name
MEDPACE LABORATORIES
Responsibilities
laboratory/testing services (codes: 4)
Name
Primevigilance Limited
Responsibilities
pharmacovigilance (codes: 8)
Name
Signant Health Global LLC
Responsibilities
Scales, Rater training, eCOA devices for scale administration, scale acquisition

Third parties

  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"codes: 3","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"codes: 1, 12, 13, 2, 5, 6, 7","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Catalent Germany Schorndorf GmbH","duties_or_roles":"codes: 14","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 Kingdom","full_name":"Primevigilance Limited","duties_or_roles":"codes: 8","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"QPS LLC","duties_or_roles":"codes: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"MEDPACE LABORATORIES","duties_or_roles":"codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"CND Life Sciences Inc.","duties_or_roles":"codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"C2n Diagnostics LLC","duties_or_roles":"codes: 4","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
ACP-204 (30 mg capsule)
Active Substance
ACP-204 TARTRATE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL
Authorisation Status
prodAuthStatus: 1
Starting Dose
30 mg
Dose Levels
30 mg; 60 mg
Maximum Dose
30 mg daily (maxTotalDoseAmount: 1260 mg over 6 months)
Investigational Product Name
ACP-204 (60 mg capsule)
Active Substance
ACP-204 TARTRATE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL
Authorisation Status
prodAuthStatus: 1
Starting Dose
60 mg
Dose Levels
30 mg; 60 mg
Maximum Dose
60 mg daily (maxTotalDoseAmount: 2520 mg over 6 months)
Investigational Product Name
Placebo for ACP-204 capsules
Modality
Other

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