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

Part of paid clinical trials in Irvine, California.

Sponsor
ACADIA Pharmaceuticals Inc.
Study ID
NCT07029581
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Lewy Body Dementia Psychosis

Eligibility Criteria

Sex
ALL
Age
55 Years - 84 Years
Healthy Volunteers
Not accepted

Interventions

  • ACP-204 — DRUG
    Provided as 1 capsule, to be taken orally once daily
  • Placebo — DRUG
    Provided as 1 capsule, to be taken orally once daily

Study Details

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

Key Dates

First listed
Jun 19, 2025
Start date
Aug 6, 2025
Status verified
Sep 2025
Primary completion
Feb 29, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Change from Baseline in SAPS-LBDP total score at Week 6 [ Time Frame: 6 weeks ]

Central Contacts

Locations (29)

FacilityCityStateZIPSite coordinators
ATP Clinical Research Inc.IrvineCalifornia92612-
The University of ColoradoAuroraColorado80045-
Georgetown UniversityWashington D.C.District of Columbia20057-
Humanity Clinical Research, CorpAventuraFlorida33180-
Parkinson's Disease and Movement Disorders Center of Boca RatonBoca RatonFlorida33486-
K2 Medical Research Winter Garden LLCClermontFlorida34711-
University of Florida - ShandsGainesvilleFlorida32608-
K2 Summit ResearchLady LakeFlorida32159-
Neurology Associates, P. A.MaitlandFlorida32751-
Advanced Clinical Research Network, CorpMiamiFlorida33135-
Homestead Associates in Research IncMiamiFlorida33032-
MediClear Medical & Research Center, Inc.MiamiFlorida33165-
Premier Clinical Research Institute, Inc.MiamiFlorida33122-
Health Synergy Clinical Research, LLCWest Palm BeachFlorida33407-
Hawaii Pacific NeuroscienceHonoluluHawaii96817-
Rush University Medical CenterChicagoIllinois60612-
University of Kansas Medical Center Research Institute Inc.Kansas CityKansas66160-
Parkinson's Disease and Movement Disorders Center of Boca Raton d/b/a Parkinson's Research Center of America-Long IslandCommackNew York11725-
UNC HospitalsChapel HillNorth Carolina27517-
Cleveland Clinic FoundationClevelandOhio44195-
The Ohio State University, Energy Advancement and Innovation CenterColumbusOhio43210-
The Movement Disorder Clinic of OklahomaTulsaOklahoma74136-
Abington Neurological Associates, LTDAbingtonPennsylvania19001-
Horizon Clinical Research GroupCypressTexas77429-
Prolato Clinical Research CenterHoustonTexas77054-
The University of Texas Health Science Center San AntonioSan AntonioTexas78229-
R and H Clinical ResearchStaffordTexas77477-
Virginia Commonwealth University (a public institution of higher education)RichmondVirginia23219-
EvergreenHealthKirklandWashington98034-

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By research site
ATP Clinical Research Inc.· Irvine, CAThe University of Colorado· Aurora, COGeorgetown University· Washington D.C., DCHumanity Clinical Research, Corp· Aventura, FLParkinson's Disease and Movement Disorders Center of Boca Raton· Boca Raton, FLK2 Medical Research Winter Garden LLC· Clermont, FL

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