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

NCT07095465 | Enrolling By Invitation Phase 3 DMC FDA Drug

• 2 other identifiers: ACP-204-0132025-521711-39-00
• Study Type: interventional
• Target: 126
• Locations: 2 countries
• Sites: 12

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

Outcome Measures

Primary Outcomes (1)

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

  52 weeks

Study Arms (1)

ACP-204

EXPERIMENTAL

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.

Drug: ACP-204

Interventions

ACP-204 DRUG

Provided as 1 capsule, to be taken orally once daily

Also known as: ACP-204 Tartrate

ACP-204

Eligibility Criteria

• Age: 55 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• The subject's LAR (or study partner/caregiver, if local regulations allow) must provide written informed consent.
• 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:
• Refrain from donating sperm, AND
• 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

You may not qualify if:

• 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:
• jeopardize the safe participation of the subject in this study; OR
• 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

Sponsors & Collaborators

• ACADIA Pharmaceuticals Inc.: lead

Study Sites (12)

Humanity Clinical Research, Corp

Aventura, Florida, 33180, United States

Location

K2 Summit Research

Lady Lake, Florida, 32159, United States

Location

Homestead Associates in Research Inc

Miami, Florida, 33032, United States

Location

Advanced Clinical Research Network, Corp

Miami, Florida, 33135, United States

Location

MediClear Medical & Research Center, Inc.

Miami, Florida, 33165, United States

Location

Health Synergy Clinical Research, LLC

West Palm Beach, Florida, 33407, United States

Location

Hawaii Pacific Neuroscience

Honolulu, Hawaii, 96817, United States

Location

University of Kansas Medical Center Research Institute Inc.

Kansas City, Kansas, 66160, United States

Location

The Ohio State University, Energy Advancement and Innovation Center

Columbus, Ohio, 43210, United States

Location

The Movement Disorder Clinic of Oklahoma

Tulsa, Oklahoma, 74136, United States

Location

R and H Clinical Research

Stafford, Texas, 77477, United States

Location

Vestra Clinics s.r.o

Rychnov nad Kněžnou, 51601, Czechia

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: July 31, 2025
• Study Start: November 14, 2025
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: April 22, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (11); CZ (1)