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NCT07029581PHASE2Recruiting

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

ACADIA Pharmaceuticals Inc.

Start Date

8/6/2025

Completion Date

3/1/2028

Summary

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

Detailed Description

Study Website: https://illumerastudy.com/

Eligibility Criteria

Age Range: 55 years to 84 years

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

Interventions

DRUG

ACP-204

DRUG

Placebo

Interested in This Trial?

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Conditions

Lewy Body Dementia Psychosis

Locations

ATP Clinical Research Inc.

Irvine, California 92612

United States

Georgetown University

Washington D.C., District of Columbia 20057

United States

Humanity Clinical Research, Corp

Aventura, Florida 33180

United States

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida 33486

United States

K2 Medical Research Winter Garden LLC

Clermont, Florida 34711

United States

University of Florida - Shands

Gainesville, Florida 32608

United States

K2 Summit Research

Lady Lake, Florida 32159

United States

Neurology Associates, P. A.

Maitland, Florida 32751

United States

Homestead Associates in Research Inc

Miami, Florida 33032

United States

Premier Clinical Research Institute, Inc.

Miami, Florida 33122

United States

Advanced Clinical Research Network, Corp

Miami, Florida 33135

United States

MediClear Medical & Research Center, Inc.

Miami, Florida 33165

United States

Health Synergy Clinical Research, LLC

West Palm Beach, Florida 33407

United States

Hawaii Pacific Neuroscience

Honolulu, Hawaii 96817

United States

Rush University Medical Center

Chicago, Illinois 60612

United States

University of Kansas Medical Center Research Institute Inc.

Kansas City, Kansas 66160

United States

Parkinson's Disease and Movement Disorders Center of Boca Raton d/b/a Parkinson's Research Center of America-Long Island

Commack, New York 11725

United States

UNC Hospitals

Chapel Hill, North Carolina 27517

United States

Cleveland Clinic Foundation

Cleveland, Ohio 44195

United States

The Ohio State University, Energy Advancement and Innovation Center

Columbus, Ohio 43210

United States

The Movement Disorder Clinic of Oklahoma

Tulsa, Oklahoma 74136

United States

Abington Neurological Associates, LTD

Abington, Pennsylvania 19001

United States

Horizon Clinical Research Group

Cypress, Texas 77429

United States

Prolato Clinical Research Center

Houston, Texas 77054

United States

The University of Texas Health Science Center San Antonio

San Antonio, Texas 78229

United States

R and H Clinical Research

Stafford, Texas 77477

United States

Virginia Commonwealth University (a public institution of higher education)

Richmond, Virginia 23219

United States

EvergreenHealth

Kirkland, Washington 98034

United States

Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry - Dr Ivo Natsov

Cherven Bryag, 5980

Bulgaria

UMHAT Sv Georgi EAD

Plovdiv, 4002

Bulgaria

Medical Center SV.Naum

Sofia, 1113

Bulgaria

DCC "Sv. Vrach and Sv. Sv. Kuzma and Damyan", OOD

Sofia, 1408

Bulgaria

UMHAT "Alexandrovska" EAD

Sofia, 1431

Bulgaria

Medical Center Detsko Zdrave Branch Maestro Kanev

Sofia, 1618

Bulgaria

DCC Mladost M- Varna, OOD

Varna, 9000

Bulgaria

Fakultni nemocnice u sv. Anny v Brne

Brno, 656 91

Czechia

NEUROHK s.r.o. Poliklinika Chocen a.s.

Choceň, 56501

Czechia

Vseobecna fakultni nemocnice v Praze

Prague, 12808

Czechia

Neuropsychiatrie s.r.o.

Prague, 16000

Czechia

Vestra Clinics s.r.o

Rychnov nad Kněžnou, 51601

Czechia

CHU de Toulouse- Hopital Purpan

Toulouse, Cedex 9 31059

France

Gérontopôle Centre de Recherche Clinique

Toulouse, Cedex 9 31059

France

Hopital Roger Salengro - CHU Lille

Lille, Nord 59037

France

Hôpital Lariboisière, Histologie et CMRR

Paris, Paris 75010

France

Hôpital des Chapennes

Villeurbanne, Rhone 69100

France

Hopital Neurologique Bron

Bron, 69677

France

Hopital BROCA

Paris, 75013

France

CHU Strasbourg-Hopital Hautepierre

Strasbourg, 67000

France

CHRU de Tours- Hopital Bretonneau

Tours, 37044

France

CHRU de Nancy- Hospital de Brabois

Vandœuvre-lès-Nancy, 54511

France

Azienda Ospedaliera Univerrsitaria

Naples, Napoli 80138

Italy

Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi D'Aragona

Salerno, Salerno 84131

Italy

Azieda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Brescia, 25123

Italy

Università Campus Bio-Medico di Roma

Roma, 128

Italy

Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza, UOI Day Hospital di Neurologia

Roma, 185

Italy

Institute of Mental Health

Belgrade, 11000

Serbia

University Clinical Center of Serbia

Belgrade, 11000

Serbia

University Clinical Hospital Center Zvezdara

Belgrade, 11000

Serbia

University Clinical Center Kragujevac

Kragujevac, 34000

Serbia