Actively Recruiting

Phase 2
Age: 55Years - 84Years
All Genders
NCT07029581

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

Led by ACADIA Pharmaceuticals Inc. · Updated on 2026-04-22

180

Participants Needed

54

Research Sites

134 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 55Years - 84Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female aged 55 years to less than 85 years living in the community or institutionalized if allowed
  • Able to provide written informed consent or have a legally authorized representative provide consent with subject assent as applicable
  • Meet clinical criteria for Parkinson's disease dementia or probable dementia with Lewy bodies
  • Meet criteria for psychosis in major or mild neurocognitive disorder according to International Psychogeriatrics Association
Not Eligible

You will not qualify if you...

  • Receiving hospice, end-of-life palliative care, or bedridden
  • Psychotic symptoms mainly caused by delirium, substance abuse, or medical/psychiatric conditions other than dementia
  • Actively suicidal at screening or baseline visits
  • History or evidence of serious or unstable medical disorders (cardiovascular, respiratory, endocrine, gastrointestinal, renal, hepatic, hematologic, immunologic, genitourinary, psychiatric, neurologic, cancer) interfering with study participation
  • Other significant central nervous system abnormalities likely contributing to dementia or seen on MRI/CT

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 54 locations

1

ATP Clinical Research Inc.

Irvine, California, United States, 92612

Actively Recruiting

2

Georgetown University

Washington D.C., District of Columbia, United States, 20057

Actively Recruiting

3

Humanity Clinical Research, Corp

Aventura, Florida, United States, 33180

Actively Recruiting

4

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, United States, 33486

Actively Recruiting

5

K2 Medical Research Winter Garden LLC

Clermont, Florida, United States, 34711

Actively Recruiting

6

University of Florida - Shands

Gainesville, Florida, United States, 32608

Actively Recruiting

7

K2 Summit Research

Lady Lake, Florida, United States, 32159

Actively Recruiting

8

Neurology Associates, P. A.

Maitland, Florida, United States, 32751

Actively Recruiting

9

Homestead Associates in Research Inc

Miami, Florida, United States, 33032

Actively Recruiting

10

Premier Clinical Research Institute, Inc.

Miami, Florida, United States, 33122

Actively Recruiting

11

Advanced Clinical Research Network, Corp

Miami, Florida, United States, 33135

Actively Recruiting

12

MediClear Medical & Research Center, Inc.

Miami, Florida, United States, 33165

Actively Recruiting

13

Health Synergy Clinical Research, LLC

West Palm Beach, Florida, United States, 33407

Actively Recruiting

14

Hawaii Pacific Neuroscience

Honolulu, Hawaii, United States, 96817

Actively Recruiting

15

University of Kansas Medical Center Research Institute Inc.

Kansas City, Kansas, United States, 66160

Actively Recruiting

16

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

Commack, New York, United States, 11725

Actively Recruiting

17

UNC Hospitals

Chapel Hill, North Carolina, United States, 27517

Actively Recruiting

18

The Ohio State University, Energy Advancement and Innovation Center

Columbus, Ohio, United States, 43210

Actively Recruiting

19

The Movement Disorder Clinic of Oklahoma

Tulsa, Oklahoma, United States, 74136

Actively Recruiting

20

Abington Neurological Associates, LTD

Abington, Pennsylvania, United States, 19001

Suspended

21

Horizon Clinical Research Group

Cypress, Texas, United States, 77429

Actively Recruiting

22

The University of Texas Health Science Center San Antonio

San Antonio, Texas, United States, 78229

Actively Recruiting

23

R and H Clinical Research

Stafford, Texas, United States, 77477

Actively Recruiting

24

Virginia Commonwealth University (a public institution of higher education)

Richmond, Virginia, United States, 23219

Actively Recruiting

25

EvergreenHealth

Kirkland, Washington, United States, 98034

Actively Recruiting

26

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

Cherven Bryag, Bulgaria, 5980

Actively Recruiting

27

UMHAT Sv Georgi EAD

Plovdiv, Bulgaria, 4002

Actively Recruiting

28

Medical Center SV.Naum

Sofia, Bulgaria, 1113

Actively Recruiting

29

UMHAT "Alexandrovska" EAD

Sofia, Bulgaria, 1431

Actively Recruiting

30

Medical Center Detsko Zdrave Branch Maestro Kanev

Sofia, Bulgaria, 1618

Actively Recruiting

31

DCC Mladost M- Varna, OOD

Varna, Bulgaria, 9000

Actively Recruiting

32

Fakultni nemocnice u sv. Anny v Brne

Brno, Czechia, 656 91

Actively Recruiting

33

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

Choceň, Czechia, 56501

Actively Recruiting

34

Vseobecna fakultni nemocnice v Praze

Prague, Czechia, 12808

Actively Recruiting

35

Neuropsychiatrie s.r.o.

Prague, Czechia, 16000

Actively Recruiting

36

Vestra Clinics s.r.o

Rychnov nad Kněžnou, Czechia, 51601

Actively Recruiting

37

CHU de Toulouse- Hopital Purpan

Toulouse, Cedex 9, France, 31059

Actively Recruiting

38

Gérontopôle Centre de Recherche Clinique

Toulouse, Cedex 9, France, 31059

Actively Recruiting

39

Hopital Roger Salengro - CHU Lille

Lille, Nord, France, 59037

Actively Recruiting

40

Hôpital Lariboisière, Histologie et CMRR

Paris, Paris, France, 75010

Actively Recruiting

41

Hôpital des Chapennes

Villeurbanne, Rhone, France, 69100

Actively Recruiting

42

Hopital Neurologique Bron

Bron, France, 69677

Actively Recruiting

43

Hopital BROCA

Paris, France, 75013

Actively Recruiting

44

CHU Strasbourg-Hopital Hautepierre

Strasbourg, France, 67000

Actively Recruiting

45

CHRU de Tours- Hopital Bretonneau

Tours, France, 37044

Actively Recruiting

46

CHRU de Nancy- Hospital de Brabois

Vandœuvre-lès-Nancy, France, 54511

Actively Recruiting

47

Azienda Ospedaliera Univerrsitaria

Naples, Napoli, Italy, 80138

Actively Recruiting

48

Azieda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Brescia, Italy, 25123

Actively Recruiting

49

Università Campus Bio-Medico di Roma

Roma, Italy, 128

Actively Recruiting

50

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

Roma, Italy, 185

Actively Recruiting

51

Institute of Mental Health

Belgrade, Serbia, 11000

Actively Recruiting

52

University Clinical Center of Serbia

Belgrade, Serbia, 11000

Actively Recruiting

53

University Clinical Hospital Center Zvezdara

Belgrade, Serbia, 11000

Actively Recruiting

54

University Clinical Center Kragujevac

Kragujevac, Serbia, 34000

Actively Recruiting

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Research Team

K

Kristin Kidd

CONTACT

B

Becky Howell

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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