NCT07029581 Phase 2, Efficacy and Safety Study of ACP-204 in Lewy Body Dementia Psychosis
| NCT ID | NCT07029581 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | ACADIA Pharmaceuticals Inc. |
| Condition | Lewy Body Dementia Psychosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2025-08-06 |
| Primary Completion | 2028-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 180 participants in total. It began in 2025-08-06 with a primary completion date of 2028-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Multicenter, randomized, 6-week, double-blind, placebo-controlled, parallel-group, Phase 2 study in subjects with LBDP.
Eligibility Criteria
Inclusion Criteria: * Male or female ≥55 years to \<85 years of age at the Screening visit living in the community or, if permitted by local regulations, in an institutionalized setting * Can 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 must provide written informed consent. 2. The subject must provide written (if capable) informed assent per local regulations. * Meets either the clinical criteria for Parkinson's disease with dementia as defined by the Movement Disorder Society's Task Force or the revised clinical criteria for probable dementia with Lewy bodies (DLB) by consensus criteria (Fourth consensus report of the DLB Consortium). * Meets the revised criteria for psychosis in major or mild neurocognitive disorder established by the International Psychogeriatrics Association Exclusion Criteria: * Is in hospice, is receiving end-of-life palliative care, or is bedridden * Has psychotic symptoms that are primarily attributable to delirium, substance abuse, or a medical or psychiatric condition (e.g. schizophrenia, bipolar disorder, delusional disorder) other than dementia * Is actively suicidal at Visit 1 (Screening) or Visit 2 (Baseline) * Has a history or current evidence of a serious and/or significant unstable cardiovascular, respiratory, endocrine, gastrointestinal, renal, hepatic, hematologic, immunologic, genitourinary, psychiatric or neurologic (including stroke, chronic seizures, or clinically significant head injury) abnormality or disease or other medical disorder, including cancer or malignancies that could interfere with subject's ability to complete the study or comply with study procedures * Has other clinically significant CNS abnormalities that are most likely contributing to the dementia or findings on MRI or CT
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07029581 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, up to 84 Years, studying Lewy Body Dementia Psychosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07029581 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07029581 currently recruiting?
Yes, NCT07029581 is actively recruiting participants. Contact the research team at Kristin.kidd@acadia-pharm.com for enrollment information.
Where is the NCT07029581 trial being conducted?
This trial is being conducted at Irvine, United States, Washington D.C., United States, Aventura, United States, Boca Raton, United States and 11 additional locations.
Who is sponsoring the NCT07029581 clinical trial?
NCT07029581 is sponsored by ACADIA Pharmaceuticals Inc.. The trial plans to enroll 180 participants.