Taking people in CzechiaPhase 3
Long-term study of ACP-204 for psychosis linked to Alzheimer's disease
Checks the long-term safety of ACP-204 in older adults with Alzheimer's psychosis.
Key facts
- Who runs it
- ACADIA Pharmaceuticals Inc.
- Where
- Brno-Stred, Choceň, Kladno, Prague, Prague 10, and Rychnov nad Kněžnou, CzechiaSee the 8 sitesAlso in 11 other countries, 98 sites
- Trial code
- Registry title
- ACP-204 in Adults With Alzheimer's Disease Psychosis Open Label Extension Study
- Status
- Enrolling by invitation
- Phase
- Phase 3
- People taking part
- 752 people, planned
- Started
- 23 Apr 2024
- Expected to end
- May 2029
- Type of study
- Interventional
- Treatments tested
- ACP-204
- Record updated
- 4 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with Alzheimer's disease psychosis who finished the earlier ACP-204-006 study and have a caregiver to attend visits with them.
- Age
- 55 to 95 years old
- Sex
- Men and women. Women must not be able to become pregnant. Men must use appropriate contraception if their partner could become pregnant.
- Disease stage
- Alzheimer's disease psychosis
- Earlier treatment
- Must have successfully completed the ACP-204-006 study.
Main reasons for not taking part
- Needs a medication that the study does not allow
- In hospice with end-of-life palliative care, or bedridden
- Unstable, clinically significant medical condition other than Alzheimer's disease
- Any medical condition that the investigator thinks may affect safety or the ability to finish the study
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 55 and 95 years old?
Where in Czechia
Also in 11 other countries, 98 sites
- Fakultni Nemocnice U Sv Anny V BrneBrno-Stred, CzechiaTaking people
- NEUROHK s r oChoceň, CzechiaTaking people
- Brain-Soultherapy s.r.o.Kladno, CzechiaTaking people
- AD71 s.r.oPrague, CzechiaTaking people
- FORBELI s.r.o.Prague, CzechiaTaking people
- INEP medical s.r.o.Prague, CzechiaTaking people
- Clintrial s.r.o.Prague 10, CzechiaTaking people
- Vestra Clinics s.r.o.Rychnov nad Kněžnou, CzechiaTaking people
About the trial
What the trial wants to find out
This 52-week, open-label extension study is to evaluate the long-term safety and tolerability of ACP-204 in subjects with ADP.
The group in the trial
- ACP-204Treatment being tested
ACP-204 30mg or 60mg
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- A 52-Week, Open-Label Extension Study of ACP-204 in Adults With Alzheimer's Disease Psychosis
- Plain-language title
- Long-term study of ACP-204 for psychosis linked to Alzheimer's diseaseGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06194799, who can take part
- Record updated
- 4 November 2026