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 States752 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 range55 Years – 95 Years
SexALL
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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.