ACP-204 in Adults With Alzheimer's Disease Psychosis Open Label Extension Study (NCT06194799) | Clinical Trial Compass
By InvitationPhase 3
ACP-204 in Adults With Alzheimer's Disease Psychosis Open Label Extension Study
United States, Brazil, Bulgaria752 participantsStarted 2024-04-23
Plain-language summary
This 52-week, open-label extension study is to evaluate the long-term safety and tolerability of ACP-204 in subjects with ADP.
Who can participate
Age range
55 Years – 95 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is an open-label extension study for ACP-204 in Alzheimer's disease psychosis — does that mean it follows a previous trial, and would my loved one need to have been in that earlier study to even be considered for this one?
2Since this is a Phase 3 trial, what do we already know about ACP-204's safety profile from earlier phases, and are there any side effects that have stood out as concerns for someone with Alzheimer's?
3The trial's main focus is tracking treatment-emergent adverse events — what does that mean in practical terms for how closely my family member would be monitored, and how often would they need to come in for check-ups?
4Given that this is an open-label extension, meaning both the doctor and patient know what's being given, how does that affect how we should interpret any improvements or side effects we notice at home?
5Are there currently approved medications for Alzheimer's-related psychosis that we should consider first before looking into an investigational drug like ACP-204?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.