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Enrolling By Invitation
NCT07095465
Phase 3, Open Label Extension Study of ACP-204 in Lewy Body Dementia Psychosis
Conditions: Lewy Body Dementia Psychosis
Sex: All
Ages: 55 Years – 84 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 126
Sponsor: ACADIA Pharmaceuticals Inc.
Location: ATP Clinical Research Inc. Irvine California
Summary
A 52-Week, Phase 3, Open-Label Extension Study of ACP-204 in Adults With Lewy Body Dementia Psychosis (LBDP)
Eligibility Criteria
Inclusion Criteria:
* The subject may benefit from long-term therapy with open-label ACP-204 treatment in the judgment of the Investigator
* Subject has completed Visit 6 (EOT) of the antecedent ACP-204-012 study and did not have an early discontinuation from the antecedent study
* Can complete all study visits with a study partner/caregiver
* Can understand the nature of the study and protocol requirements and provide written informed consent. If the subject is deemed not competent to provide informed consent, the following requirements for consent must be met:
1. The subject's LAR (or study partner/caregiver, if local regulations allow) must provide written informed consent.
2. The subject must provide written (if capable) informed assent per local regulations
* If the subject is a female, she must be of nonchildbearing potential
* If the subject is male, he must agree to the following during the study intervention period and for at least 90 days after the last dose of study drug:
1. Refrain from donating sperm, AND
2. Either
* Be abstinent from sexual intercourse where pregnancy can occur (abstinent on a long-term and persistent basis) and agree to remain abstinent OR
* Use a condom and subject's female partner (if of childbearing potential and not pregnant) must use an additional contraceptive method
Exclusion Criteria:
* Is judged by the Investigator or the Medical Monitor to be inappropriate for the study for any reason
* Is in hospice, is receiving end-of-life palliative care, or is bedridden
* Has a heart rate \
Source: ClinicalTrials.gov (NCT07095465). StuddyBuddy aggregates publicly available trial information.