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 (18) 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
Florida
Humanity Clinical Research, Corp
RECRUITING
Aventura
K2 Medical Research Winter Garden LLC
RECRUITING
Clermont
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
Kansas
University of Kansas Medical Center Research Institute Inc.
RECRUITING
Kansas City
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
Oklahoma
The Movement Disorder Clinic of Oklahoma
RECRUITING
Tulsa
Pennsylvania
Abington Neurological Associates, LTD
RECRUITING
Abington
Texas
Horizon Clinical Research Group
RECRUITING
Cypress
R and H Clinical Research
RECRUITING
Stafford
Virginia
Virginia Commonwealth University (a public institution of higher education)