NCT07095465
Phase 3, Open Label Extension Study of ACP-204 in Lewy Body Dementia Psychosis
Enrolling by Invitation
PHASE3Ages 55–84InterventionalTreatmentACADIA Pharmaceuticals Inc.
~126 participants
Updated 2026-07-24 on ClinicalTrials.gov
What's tested:ACP-204
At a glance
Recruiting sites
0 of 30 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of subjects who experience treatment-emergent adverse events (TEAEs)
Measured over 52 weeks
Conditions
Where it's being run
30 sites across 18 statesFlorida7
Bulgaria3
Czechia3
Texas2
Roma2
California1
Hawaii1
Kansas1
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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:
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:
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
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 \<50 beats per minute, as measured by vital signs at Baseline (EOT visit of the antecedent study). If bradycardia is secondary to iatrogenic or treatable causes and these causes are addressed, a heart rate assessment can be repeated.
Has a BMI \<18.5 kg/m2 or known unintentional weight loss ≥7% of body weight over past 6 months
Has a clinically significant laboratory abnormality in the antecedent ACP-204-012 study, excepting at ACP-204-012 EOT, that in the judgment of the Investigator or Medical Monitor, will either:
Is actively suicidal at Visit 1 (Baseline, EOT visit of the antecedent study)
Has a neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical or mental disorder, including cancer or malignancies that, in the judgment of the Investigator, would increase the risk associated with taking study medication or significantly interfere with the conduct or interpretation of the study
Requires treatment with a medication or other substance that is prohibited by the protocol or will be used in a way that violates a use restriction
What this trial measures
- Proportion of subjects who experience treatment-emergent adverse events (TEAEs)52 weeks