NCT07029581RecruitingPhase 2
A Double-Blind, Placebo-Controlled, Phase 2, Efficacy and Safety Study of ACP-204 in Adults With Lewy Body Dementia Psychosis (LBDP)
ACADIA Pharmaceuticals Inc.77 sites in 4 countries180 target enrollmentStarted: August 6, 2025Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- ACADIA Pharmaceuticals Inc.
- Enrollment
- 180
- Locations
- 77
- Primary Endpoint
- Change from Baseline in SAPS-LBDP total score at Week 6
Study Overview
Brief Summary
Multicenter, randomized, 6-week, double-blind, placebo-controlled, parallel-group, Phase 2 study in subjects with LBDP.
Detailed Description
Study Website: https://illumerastudy.com/
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 55 Years to 84 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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:
- •The subject's LAR must provide written informed consent.
- •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
Arms & Interventions
ACP-204 60 mg
Experimental
ACP-204 dose of 60 mg once daily
Intervention: ACP-204 (Drug)
ACP-204 30 mg
Experimental
ACP-204 dose of 30 mg once daily
Intervention: ACP-204 (Drug)
Placebo
Placebo Comparator
Placebo once daily
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change from Baseline in SAPS-LBDP total score at Week 6
Time Frame: 6 weeks
Change from Baseline in Scale for the Assessment of Positive Symptoms- Lewy Body Dementia Psychosis (SAPS-LBDP) total score at Week 6
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (77)
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