Recruiting
Phase 3

ACP-204

Sponsor:

ACADIA Pharmaceuticals Inc.

Code:

NCT07095465

Conditions

Lewy Body Dementia Psychosis

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

Interventions

ACP-204

Study Details

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 ID

NCT07095465

Start date

Nov 14, 2025

Status verified date

Sep, 2026

Completion date

Mar, 2029

Anticipated

Primary completion date

Feb, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not 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

Study Design

Enrollment

126 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

ACP-204

Provided as 1 capsule, to be taken orally once daily

Primary outcome measure

  • Proportion of subjects who experience treatment-emergent adverse events (TEAEs) [ Time Frame: 52 weeks ]

Central Contacts and Locations

Central contacts

Kristin Kidd

434-841-3162Kristin.kidd@acadia-pharm.com

Becky Howell

848-702-1886bhowell@acadia-pharm.com

Locations

ATP Clinical Research Inc.

Recruiting

Irvine, California, United States, 92612

Humanity Clinical Research, Corp

Recruiting

Aventura, Florida, United States, 33180

Parkinson's Disease and Movement Disorders Center of Boca Raton

Recruiting

Boca Raton, Florida, United States, 33486

K2 Summit Research

Recruiting

Lady Lake, Florida, United States, 32159

Homestead Associates in Research Inc

Recruiting

Miami, Florida, United States, 33032

Advanced Clinical Research Network, Corp

Recruiting

Miami, Florida, United States, 33135

MediClear Medical & Research Center, Inc.

Recruiting

Miami, Florida, United States, 33165

Health Synergy Clinical Research, LLC

Recruiting

West Palm Beach, Florida, United States, 33407

Hawaii Pacific Neuroscience

Recruiting

Honolulu, Hawaii, United States, 96817

University of Kansas Medical Center Research Institute Inc.

Recruiting

Kansas City, Kansas, United States, 66160

Parkinson's Disease and Movement Disorders Center of Boca Raton d/b/a Parkinson's Research Center of America-Long Island

Recruiting

Commack, New York, United States, 11725

The Ohio State University, Energy Advancement and Innovation Center

Recruiting

Columbus, Ohio, United States, 43210

The Movement Disorder Clinic of Oklahoma

Recruiting

Tulsa, Oklahoma, United States, 74136

Horizon Clinical Research Group

Recruiting

Cypress, Texas, United States, 77429

The University of Texas Health Science Center San Antonio

Recruiting

San Antonio, Texas, United States, 78229

R and H Clinical Research

Recruiting

Stafford, Texas, United States, 77477

Virginia Commonwealth University (a public institution of higher education)

Recruiting

Richmond, Virginia, United States, 23219

EvergreenHealth

Recruiting

Kirkland, Washington, United States, 98034

More Information

Sponsor

ACADIA Pharmaceuticals Inc.

Last update posted

Sep 29, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-30. This information was provided to ClinicalTrials.gov by ACADIA Pharmaceuticals Inc. on 2026-09-29. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.