Skip to main content
Delfa

← Trials/Trial dossier/NCT07095465

Enrolling by invitationPhase 3

Phase 3, Open Label Extension Study of ACP-204 in Lewy Body Dementia Psychosis

52-Week, Phase 3, Open-Label Extension Study of ACP-204 in Adults With Lewy Body Dementia Psychosis (LBDP)

Asset

ACP-204

Listed sites

15

Recruiting sites

-

Enrollment

126

estimated

Study population

Lewy body dementia

Key I/E criterion

•Study partner/caregiver required

Primary endpoint

•Proportion of subjects who experience treatment-emergent adverse events (TEAEs)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Ctis2025-521711-39-00
Org study IDACP-204-013
NCT IDNCT07095465

Timeline

Milestones

Study first posted2025-07-31actual
Study start2025-11-14actual
Last update posted2026-05-29actual
Primary completion2029-02estimated (month precision)
Study completion2029-03estimated (month precision)

Assets

Drug assets

ACP-204

Study populations

Who this study enrolls

Lewy body dementia

Eligibility

Who can enroll

Minimum age55 Years
Maximum age84 Years
SexAll
Healthy volunteersNot accepted

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 <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:

1. jeopardize the safe participation of the subject in this study; OR

2. interfere with the conduct or interpretation of safety or efficacy evaluations in the study

•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

Endpoints (1)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

Proportion of subjects who experience treatment-emergent adverse events (TEAEs)

Time frame:52 weeks

threshold achievement, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.