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Recruiting Phase 2

Phase 2, Efficacy and Safety Study of ACP-204 in Lewy Body Dementia Psychosis

NCT07029581 · tracked via the Priya Life Science Italy tracker
Phase
Phase 2
Started
2025-08-06
Last updated
2026-09-29

Condition(s) studied

Lewy Body Dementia Psychosis

Investigational drug(s) / intervention(s)

ACP-204 →Placebo

ACP-204: Provided as 1 capsule, to be taken orally once daily

Placebo: Provided as 1 capsule, to be taken orally once daily

Study summary

Multicenter, randomized, 6-week, double-blind, placebo-controlled, parallel-group, Phase 2 study in subjects with LBDP.

Eligibility

Sex
ALL
Min age
55 Years
Max age
84 Years
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: 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

Primary outcome measure(s)

  • Change from Baseline in SAPS-LBDP total score at Week 6 — 6 weeks
    Change from Baseline in Scale for the Assessment of Positive Symptoms- Lewy Body Dementia Psychosis (SAPS-LBDP) total score at Week 6

Trial sites (61)

FacilityCityRegionStatus
ATP Clinical Research Inc. Irvine California Recruiting
The University of Colorado Aurora Colorado Recruiting
Georgetown University Washington D.C. District of Columbia Recruiting
Humanity Clinical Research, Corp Aventura Florida Recruiting
Parkinson's Disease and Movement Disorders Center of Boca Raton Boca Raton Florida Recruiting
K2 Medical Research Winter Garden LLC Clermont Florida Recruiting
University of Florida - Shands Gainesville Florida Recruiting
K2 Summit Research Lady Lake Florida Recruiting
Neurology Associates, P. A. Maitland Florida Terminated
Homestead Associates in Research Inc Miami Florida Recruiting
Premier Clinical Research Institute, Inc. Miami Florida Recruiting
Advanced Clinical Research Network, Corp Miami Florida Recruiting
Verus Clinical Research Miami Florida Recruiting
MediClear Medical & Research Center, Inc. Miami Florida Recruiting
Health Synergy Clinical Research, LLC West Palm Beach Florida Recruiting
Hawaii Pacific Neuroscience Honolulu Hawaii Recruiting
Rush University Medical Center Chicago Illinois Recruiting
University of Kansas Medical Center Research Institute Inc. Kansas City Kansas Recruiting
Parkinson's Disease and Movement Disorders Center of Boca Raton d/b/a Parkinson's Research Center of America-Long Island Commack New York Recruiting
UNC Hospitals Chapel Hill North Carolina Recruiting
Cleveland Clinic Foundation Cleveland Ohio Recruiting
The Ohio State University, Energy Advancement and Innovation Center Columbus Ohio Recruiting
The Movement Disorder Clinic of Oklahoma Tulsa Oklahoma Recruiting
Abington Neurological Associates, LTD Abington Pennsylvania Withdrawn
Horizon Clinical Research Group Cypress Texas Recruiting
Prolato Clinical Research Center Houston Texas Recruiting
The University of Texas Health Science Center San Antonio San Antonio Texas Recruiting
R and H Clinical Research Stafford Texas Recruiting
Virginia Commonwealth University (a public institution of higher education) Richmond Virginia Recruiting
EvergreenHealth Kirkland Washington Recruiting
Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry - Dr Ivo Natsov Cherven Bryag Bulgaria Recruiting
UMHAT Sv Georgi EAD Plovdiv Bulgaria Recruiting
Medical Center SV.Naum Sofia Bulgaria Recruiting
DCC "Sv. Vrach and Sv. Sv. Kuzma and Damyan", OOD Sofia Bulgaria Recruiting
UMHAT "Alexandrovska" EAD Sofia Bulgaria Recruiting
Medical Center Detsko Zdrave Branch Maestro Kanev Sofia Bulgaria Withdrawn
DCC Mladost M- Varna, OOD Varna Bulgaria Recruiting
Fakultni nemocnice u sv. Anny v Brne Brno Czechia Recruiting
NEUROHK s.r.o. Poliklinika Chocen a.s. Choceň Czechia Recruiting
Vseobecna fakultni nemocnice v Praze Prague Czechia Recruiting

+ 21 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07029581 on ClinicalTrials.gov ↗ ← All trials in Italy