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

NCT ID: NCT07095465

Last Updated: 2025-12-26

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE3
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2029-03-31

Brief Summary

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

Conditions

Lewy Body Dementia Psychosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ACP-204

Initiation of treatment with ACP-204 at a dose of 30 mg once daily. During the trial, the dose may be adjusted, i.e. uptitration to 60 mg in case of suboptimal efficacy or subsequent down titration to 30 mg. Repeated titration steps are allowed.

Group Type: EXPERIMENTAL

ACP-204

Intervention Type: DRUG

Provided as 1 capsule, to be taken orally once daily

Interventions

ACP-204

Provided as 1 capsule, to be taken orally once daily

Intervention Type: DRUG

Other Intervention Names

ACP-204 Tartrate

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 <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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 84 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ACADIA Pharmaceuticals Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Humanity Clinical Research, Corp

Aventura, Florida, United States

Homestead Associates in Research Inc

Miami, Florida, United States

Advanced Clinical Research Network, Corp

Miami, Florida, United States

Health Synergy Clinical Research, LLC

West Palm Beach, Florida, United States

Countries

United States

Other Identifiers

2025-521711-39-00

Identifier Type: CTIS

Identifier Source: secondary_id

ACP-204-013

Identifier Type: -

Identifier Source: org_study_id