A Double-Blind, Placebo-Controlled, Phase 2, Efficacy and Safety Study of ACP-204 in Adults With Lewy Body Dementia Psychosis (LBDP)
Status: Recruiting
Location: See all (55) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
Multicenter, randomized, 6-week, double-blind, placebo-controlled, parallel-group, Phase 2 study in subjects with LBDP.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Maximum Age: 84
Healthy Volunteers: f
View:
• 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
Locations
United States
California
ATP Clinical Research Inc.
RECRUITING
Irvine
Colorado
The University of Colorado
RECRUITING
Aurora
Washington, D.c.
Georgetown University
RECRUITING
Washington D.c.
Florida
Humanity Clinical Research, Corp
RECRUITING
Aventura
Parkinson's Disease and Movement Disorders Center of Boca Raton
RECRUITING
Boca Raton
K2 Medical Research Winter Garden LLC
RECRUITING
Clermont
University of Florida - Shands
RECRUITING
Gainesville
K2 Summit Research
RECRUITING
Lady Lake
Neurology Associates, P. A.
RECRUITING
Maitland
Advanced Clinical Research Network, Corp
RECRUITING
Miami
Homestead Associates in Research Inc
RECRUITING
Miami
MediClear Medical & Research Center, Inc.
RECRUITING
Miami
Premier Clinical Research Institute, Inc.
RECRUITING
Miami
Health Synergy Clinical Research, LLC
RECRUITING
West Palm Beach
Hawaii
Hawaii Pacific Neuroscience
RECRUITING
Honolulu
Illinois
Rush University Medical Center
RECRUITING
Chicago
Kansas
University of Kansas Medical Center Research Institute Inc.
RECRUITING
Kansas City
North Carolina
UNC Hospitals
RECRUITING
Chapel Hill
New York
Parkinson's Disease and Movement Disorders Center of Boca Raton d/b/a Parkinson's Research Center of America-Long Island
RECRUITING
Commack
Ohio
Cleveland Clinic Foundation
RECRUITING
Cleveland
The Ohio State University, Energy Advancement and Innovation Center
RECRUITING
Columbus
Oklahoma
The Movement Disorder Clinic of Oklahoma
RECRUITING
Tulsa
Pennsylvania
Abington Neurological Associates, LTD
WITHDRAWN
Abington
Texas
Horizon Clinical Research Group
RECRUITING
Cypress
Prolato Clinical Research Center
RECRUITING
Houston
The University of Texas Health Science Center San Antonio
RECRUITING
San Antonio
R and H Clinical Research
RECRUITING
Stafford
Virginia
Virginia Commonwealth University (a public institution of higher education)
RECRUITING
Richmond
Washington
EvergreenHealth
RECRUITING
Kirkland
Other Locations
Bulgaria
Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry - Dr Ivo Natsov
RECRUITING
Cherven Bryag
UMHAT Sv Georgi EAD
RECRUITING
Plovdiv
DCC Sv. Vrach and Sv. Sv. Kuzma and Damyan, OOD
RECRUITING
Sofia
Medical Center Detsko Zdrave Branch Maestro Kanev
RECRUITING
Sofia
Medical Center SV.Naum
RECRUITING
Sofia
UMHAT Alexandrovska EAD
RECRUITING
Sofia
DCC Mladost M- Varna, OOD
RECRUITING
Varna
France
Hopital Neurologique Bron
RECRUITING
Bron
Hopital Roger Salengro - CHU Lille
RECRUITING
Lille
Hopital BROCA
WITHDRAWN
Paris
Hôpital Lariboisière, Histologie et CMRR
RECRUITING
Paris
CHU Strasbourg-Hopital Hautepierre
RECRUITING
Strasbourg
CHU de Toulouse- Hopital Purpan
RECRUITING
Toulouse
Gérontopôle Centre de Recherche Clinique
RECRUITING
Toulouse
CHRU de Tours- Hopital Bretonneau
RECRUITING
Tours
CHRU de Nancy- Hospital de Brabois
RECRUITING
Vandœuvre-lès-nancy
Hôpital des Chapennes
RECRUITING
Villeurbanne
Italy
Azieda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
RECRUITING
Brescia
Azienda Ospedaliera Univerrsitaria
RECRUITING
Naples
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza, UOI Day Hospital di Neurologia
RECRUITING
Roma
Università Campus Bio-Medico di Roma
RECRUITING
Roma
Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi D'Aragona
RECRUITING
Salerno
Serbia
Institute of Mental Health
RECRUITING
Belgrade
University Clinical Center of Serbia
RECRUITING
Belgrade
University Clinical Hospital Center Zvezdara
RECRUITING
Belgrade
University Clinical Center Kragujevac
RECRUITING
Kragujevac
Contact Information
Primary
Kristin Kidd
Kristin.kidd@acadia-pharm.com
434-841-3162
Backup
Becky Howell
bhowell@acadia-pharm.com
848-702-1886
Time Frame
Start Date: 2025-08-06
Estimated Completion Date: 2028-03
Participants
Target number of participants: 180
Treatments
Experimental: ACP-204 30 mg
ACP-204 dose of 30 mg once daily
Experimental: ACP-204 60 mg
ACP-204 dose of 60 mg once daily
Placebo_comparator: Placebo
Placebo once daily
Related Therapeutic Areas
Sponsors
Leads: ACADIA Pharmaceuticals Inc.