Clinical Trials in Italy / NCT07029581
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
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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.
More ACADIA Pharmaceuticals Inc. trials in Italy
Other trials for the same condition
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