ACP-204 in Adults With Alzheimer's Disease Psychosis Open Label Extension Study

Enrolling by invitation · Phase 3

Conditions studied: Alzheimer's Disease Psychosis

In brief

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

Key facts

Study ID

NCT06194799

Run by

ACADIA Pharmaceuticals Inc.

People needed

752

Starts

2024-04-23

Expected to finish

2029-05-01

Last updated by the study team

2026-08-05

Who can join

Age: 55 and older, up to 95. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Requires treatment with a medication prohibited by the protocol
• Is in hospice and receiving end-of-life palliative care, or has become bedridden
• 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.

Where it is running

• Neuro-Pain Medical Center — Fresno, California, United States
• National Institute Of Clinical Research — Garden Grove, California, United States
• Humanity Clinical Research, Corp — Aventura, Florida, United States
• New Life Medical Research Center — Hialeah, Florida, United States
• Reliable Clinical Research LLC — Hialeah, Florida, United States
• Homestead Associates in Research Inc. — Miami, Florida, United States
• Premier Clinical Research Institute Inc — Miami, Florida, United States
• Advanced Clinical Research — Miami, Florida, United States
• Verus Clinical Research — Miami, Florida, United States
• Quantum Clinical Trials — Miami, Florida, United States
• Future Care Solution, LLC — Miami, Florida, United States
• MediClear Medical & Research Center, Inc. — Miami, Florida, United States
• ABBA Medical Research LLC — Miami, Florida, United States
• New Med Research — Miami Gardens, Florida, United States
• Floridian Neuroscience Institute — Miami Lakes, Florida, United States
• Abington Neurological Associates — Abington, Pennsylvania, United States
• Horizon Clinical Research Group — Cypress, Texas, United States
• Uni Texas Health Science Center — Houston, Texas, United States
• Clinical Trial Network LLC — Houston, Texas, United States
• Kaleidoscope Clinical Research — Houston, Texas, United States
• Hospital Moinhos de Vento — Porto Alegre, Rio Grande do Sul, Brazil
• Hospital Universitario de Brasilia — Brasília, Brazil
• CECPAR Centro de Estudos Clinicos do Parana — Curitiba, Brazil
• TrialTech Tecnologia com Pesquisas em Medicamentos — Curitiba, Brazil
• ATP Clinical Research — Costa Mesa, California, United States

Full record on ClinicalTrials.gov

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