NCT07095465 · ACADIA Pharmaceuticals Inc.
Phase 3, Open Label Extension Study of ACP-204 in Lewy Body Dementia Psychosis
What this study is about
A 52-Week, Phase 3, where both patients and doctors know the treatment given Extension Study of ACP-204 in Adults With Lewy Body Dementia Psychosis (LBDP)
View original scientific description
A 52-Week, Phase 3, Open-Label Extension Study of ACP-204 in Adults With Lewy Body Dementia Psychosis (LBDP)
Interventions
DRUG
ACP-204
Provided as 1 capsule, to be taken orally once daily
Primary outcome measures
Proportion of subjects who experience treatment-emergent adverse events (TEAEs)
Time frame: 52 weeks
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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:
- 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
- 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:
- 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
Where
- Irvine, California
- Aventura, Florida
- Boca Raton, Florida
- Lady Lake, Florida
- Miami, Florida
- West Palm Beach, Florida
- Honolulu, Hawaii
- Kansas City, Kansas
- Commack, New York
- Columbus, Ohio
- Tulsa, Oklahoma
- Cypress, Texas
And 4 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 29, 2026 · Source of record for eligibility and locations