Clinical trial NCT06194799: ACP-204 in Adults With Alzheimer's Disease Psychosis Open Label Extension Study
Official title: A 52-Week, Open-Label Extension Study of ACP-204 in Adults With Alzheimer's Disease Psychosis
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE3
Conditions: Alzheimer's Disease Psychosis
Keywords: Alzheimer's Disease Psychosis
Hallucinations
Delusions
Lead sponsor: ACADIA Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2024-01-08
Enrollment: 752
Sex: ALL
Minimum age (years): 55
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This 52-week, open-label extension study is to evaluate the long-term safety and tolerability of ACP-204 in subjects with ADP.


Eligibility criteria: Inclusion Criteria:

* Subject has successfully completed ACP-204-006 study
* Male or female (age 55 to 95 years old): female must be of non-childbearing potential, male must take appropriate contraceptive method if partner has childbearing potential
* Subject has a designated study partner/caregiver
* Subjects are able to complete all study visits with a study partner/caregiver
* Signed inform consent form with a caregiver or legal representative

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
* Female who is pregnant or breastfeeding
* Unstable clinically significant medical condition other than AD
* Any medical condition that in the opinion of the investigator may affect safety or ability to complete the study

Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met.

Primary outcomes:
measure: Treatment-emergent adverse events
timeFrame: 52 Weeks
Secondary outcomes:
measure: Clinical Global Impression-Improvement in the ADP context (CGI-I-ADP) score
timeFrame: 52 Weeks
Other outcomes:
Locations:
city: Costa Mesa
country: United States
facility: ATP Clinical Research
state: California
city: Garden Grove
country: United States
facility: National Institute Of Clinical Research
state: California
city: Hialeah
country: United States
facility: New Life Medical Research Center
state: Florida
city: Hialeah
country: United States
facility: Reliable Clinical Research LLC
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: Advanced Clinical Research
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: Abington
country: United States
facility: Abington Neurological Associates
state: Pennsylvania
city: Houston
country: United States
facility: Uni Texas Health Science Center
state: Texas
city: Porto Alegre
country: Brazil
facility: Hospital Moinhos de Vento
state: RS
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: Rio de Janeiro
country: Brazil
facility: Ruschel Medicina e Pesquisa Clínica
city: Cherven bryag
country: Bulgaria
facility: ET Dr. Ivo Natsov-AIPSMC in Psychiatry
city: Pazardzhik
country: Bulgaria
facility: DCC Higia
city: Pleven
country: Bulgaria
facility: Medical center Medconsult Pleven OOD
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: 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: Kladno
country: Czechia
facility: BRAIN-SOULTHERAPY s.r.o
city: Praha 10
country: Czechia
facility: Clinical s.r.o
city: Praha
country: Czechia
facility: AD71 s.r.o
city: Paris
country: France
facility: Hôpital Lariboisière
city: Toulouse
country: France
facility: Hôpital La Grave
city: Brescia
country: Italy
facility: ASST Spedali Civili di Brescia
city: Salerno
country: Italy
facility: Azienda Ospedaliera Universitaria OO. RR. S
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Boramae Medical Center
city: Monterrey
country: Mexico
facility: Iecsi S.C.
state: Nuevo Leon
city: San Luis Potosí
country: Mexico
facility: BIND Investigaciones S.C.
city: Belgrade
country: Serbia
facility: Clinical Center Dr Dragisa Misovic Dedinje
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Municipal Ta-Tung Hospital
city: Kaohsiung City
country: Taiwan
facility: E-DA Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
Study officials:
References: