Clinical trial • Phase III • Neurology

ACP-204 TARTRATE for Alzheimer's disease psychosis | Alzheimer's disease

Phase III trial of ACP-204 TARTRATE for Alzheimer's disease psychosis | Alzheimer's disease. open-label, none/not specified-controlled. 752 participants.

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Alzheimer's disease psychosis | Alzheimer's disease
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
09-02-2024
First CTIS Authorization Date
31-05-2024

Trial design

open-label, none/not specified-controlled Phase III trial across 47 sites in Bulgaria, Czechia, Spain and others.

Open Label
Yes
Comparator
None/Not specified
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
752
Trial Duration For Participant
364

Eligibility

Recruits 752 Vulnerable population selected: participants with Alzheimer's disease psychosis (cognitive impairment). Consent must be signed with a caregiver or legal representative; a designated study partner/caregiver is required and subjects must be able to complete visits with that caregiver. Multiple caregiver/participant informed consent and caregiver ICF documents are provided (language-specific versions available)..

Pregnancy Exclusion
female must be of non-childbearing potential
Vulnerable Population
Vulnerable population selected: participants with Alzheimer's disease psychosis (cognitive impairment). Consent must be signed with a caregiver or legal representative; a designated study partner/caregiver is required and subjects must be able to complete visits with that caregiver. Multiple caregiver/participant informed consent and caregiver ICF documents are provided (language-specific versions available).

Inclusion criteria

  • {"criterion_text":"- Subject has successfully completed ACP-204-006 study\n- Male or female (age 55 to 85 years old): female must be of non-childbearing potential, male must take appropriate contraceptive method if partner has childbearing potential\n- Subject has a designated study partner/caregiver\n- Subjects are able to complete all study visits with a study partner/caregiver\n- Signed inform consent form with a caregiver or legal representative"}

Exclusion criteria

  • {"criterion_text":"- Requires treatment with a medication prohibited by the protocol\n- Is in hospice and receiving end-of-life palliative care, or has become bedridden\n- Unstable clinically significant medical condition other than AD\n- Any medical condition that in the opinion of the investigator may affect safety or ability to complete the study"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Treatment-emergent adverse events [Time Frame: 52 Weeks] Number of Subjects With Adverse Events (AEs), Discontinuations Due to AEs and Serious AEs (SAEs) over 52 weeks of treatment. The Safety population consists of all subjects who received at least one dose of study drug in this study.","definition_or_measurement_approach":"Number of subjects with AEs, discontinuations due to AEs and SAEs over 52 weeks; Safety population = all subjects who received at least one dose of study drug."}

Secondary endpoints

  • {"endpoint_text":"- Clinical Global Impression-Improvement in the ADP context (CGI-I-ADP) score [Time Frame: 52 Weeks]","definition_or_measurement_approach":"CGI-I-ADP score measured over 52 weeks."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
752
Recruitment Window Months
60
Consent Approach
Informed consent obtained from subject with caregiver or legal representative as appropriate. A separate caregiver/partner informed consent form is used. eConsent materials and participant-facing landing pages, screenshots, video storyboard and multilingual consent documentation are provided (documents available in English, Spanish, French, Czech, Bulgarian, Italian and other local languages). Subjects with impaired capacity sign consent with caregiver/legal representative involvement; study partner/caregiver required.

Geography

Total Number Of Sites
47
Total Number Of Participants
196

Bulgaria

Earliest CTIS Part Ii Submission Date
03-01-2024
Latest Decision Or Authorization Date
04-06-2024
Processing Time Days
153
Number Of Sites
13
Number Of Participants
57

Sites

Site Name
Higya–DCC OOD
Contact Person Name
Dora Atanasova
Contact Person Email
dora_pazardjik@abv.bg
Site Name
Medical Center Lifemed EOOD
Contact Person Name
Rozaliya Rangelova
Contact Person Email
rrangelova80@gmail.com
Site Name
Alexandrovska University Hospital
Department Name
Clinic of neurological disorders
Contact Person Name
Latchezar Traykov
Contact Person Email
traykov_l@yahoo.fr
Site Name
Medical Center Intermedica Ltd.
Contact Person Name
Toni Donchev
Contact Person Email
tonyd@abv.bg
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 Medconsult Pleven OOD
Contact Person Name
Mariya Alexandrova-Stoycheva
Contact Person Email
doc_maria_aleksandrova@abv.bg
Site Name
Center For Mental Health Prof. N. Shipkovenski EOOD
Contact Person Name
Ana Popova
Contact Person Email
dr.anapopova@gmail.com
Site Name
Alexandrovska University Hospital
Department Name
Clinic of Psychiatry
Contact Person Name
Georgi Onchev
Contact Person Email
georgi.onchev@gmail.com
Site Name
Umbal - Prof. D-R Stoyan Kirkovich AD
Department Name
Department of Psychiatry
Contact Person Name
Georgi Panov
Contact Person Email
dr.georgi.panov@gmail.com
Site Name
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Department Name
Clinic of Psychiatry
Contact Person Name
Andriana Kakanakova
Site Name
Medical Center Hera EOOD
Contact Person Name
Spiridon Spiridonov
Contact Person Email
spiridon.aleksiev@gmail.com
Site Name
Medical Center Spectar Plovdiv EOOD
Contact Person Name
Nikolay Popov
Contact Person Email
nikpopov@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

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
46

Sites

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
Site Name
INEP medical s.r.o.
Contact Person Name
Alexander Nawka
Contact Person Email
nawka@inep.cz
Site Name
Ad71 s.r.o.
Contact Person Name
Ilona Divacka
Contact Person Email
info@vodopad.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
Clintrial s.r.o.
Contact Person Name
Zdenek Solle
Contact Person Email
zdenek.solle@clintrial.cz
Site Name
Neurohk s.r.o.
Contact Person Name
Martin Valis
Contact Person Email
valismar@seznam.cz
Site Name
Brain-Soultherapy s.r.o.
Contact Person Name
Klaudia Vodickova Borzova
Contact Person Email
cborzova@seznam.cz

Spain

Earliest CTIS Part Ii Submission Date
06-05-2024
Latest Decision Or Authorization Date
31-05-2024
Processing Time Days
25
Number Of Sites
4
Number Of Participants
14

Sites

Site Name
Hospital Germans Trias I Pujol
Department Name
Neurology
Contact Person Name
Pau Pastor Muñoz
Site Name
Hospital Universitario Regional De Malaga
Department Name
Neurology
Contact Person Name
Pedro Jesus Serrano Castro
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 Universitario Virgen De La Macarena
Department Name
Neurology
Contact Person Name
Felix Vinuela Fernandez
Contact Person Email
fvinuelaf@gmail.com

Italy

Earliest CTIS Part Ii Submission Date
03-01-2024
Latest Decision Or Authorization Date
31-05-2024
Processing Time Days
149
Number Of Sites
10
Number Of Participants
43

Sites

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
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
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Neurology
Contact Person Name
Davide Quaranta
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 Ospedaliero-Universitaria Policlinico Umberto I
Department Name
Neurology
Contact Person Name
Giuseppe Bruno
Contact Person Email
giuseppe.bruno@uniroma1.it
Site Name
Universita' Campus Bio-medico Di Roma
Department Name
Neurology
Contact Person Name
Vincenzo Di Lazzaro
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 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
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
Pia Fondazione Di Culto E Religione Card G Panico
Department Name
Neurology
Contact Person Name
Daniele Urso
Contact Person Email
d.urso@piafondazionepanico.it

France

Earliest CTIS Part Ii Submission Date
22-04-2024
Latest Decision Or Authorization Date
03-06-2024
Processing Time Days
42
Number Of Sites
12
Number Of Participants
36

Sites

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 Pasteur
Department Name
Centre pour Personnes Âgées
Contact Person Name
Pierre ANTHONY
Contact Person Email
pierre.anthony@ch-colmar.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
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
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
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
Hospital Pierre Wertheimer
Department Name
Service Neurologie
Contact Person Name
Hélène MOLLION
Contact Person Email
helene.mollion@chu-lyon.fr
Site Name
Hospices Civils De Lyon
Department Name
Centre de Recherche Clinique
Contact Person Name
Antoine GARNIER-CRUSSARD
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
Pôle de gériatrie
Contact Person Name
Hermine LENOIR
Contact Person Email
hermine.lenoir@aphp.fr
Site Name
CHRU De Nancy
Department Name
Départment Gériatrie Aigue
Contact Person Name
Laure JOLY
Contact Person Email
l.joly@chru-nancy.fr

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
multiple operational roles (codes: 1,12,13,2,5,6,7,8) as listed in sponsor duties
Name
Parexel International Corp.
Responsibilities
case processing; monitoring/support (duty entries include 'case processing' and code 8)
Name
Signant Health Global LLC
Responsibilities
Scales, rater training, eCOA devices for scale administration, scale acquisition

Third parties

  • {"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":"IQVIA Limited","duties_or_roles":"codes: 1,12,13,2,5,6,7,8 (roles provided as codes in source)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Gray Consulting Inc.","duties_or_roles":"travel and reimbursement vendor","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"case processing; code 8","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Icon Laboratory Services Inc.","duties_or_roles":"code:4","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 number DE_BW_01_MIA_2024_0081
Starting Dose
30 mg
Dose Levels
30 mg; 60 mg
Frequency
once daily
Maximum Dose
60 mg
Dose Escalation Increase
initial 30 mg, following 60 mg

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