Actively Recruiting
A Master Protocol for Three Independent, Double-blind, Placebo-controlled Studies of ACP-204 in Adults With Alzheimer's Disease Psychosis
Led by ACADIA Pharmaceuticals Inc. · Updated on 2026-06-08
1074
Participants Needed
145
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a master protocol involving three independent, multicenter, randomized, double-blind, placebo-controlled studies to evaluate ACP-204 in adults with Alzheimer's Disease Psychosis (ADP). The studies aim to assess the efficacy and dose response of ACP-204, a drug targeting serotonin receptor subtype 2A, in this population. The research includes early phase 2 and later phase 3 confirmatory studies to independently analyze treatment effects. The studies consist of three substudies: Substudy 1 (phase 2) tests ACP-204 doses of 30 mg and 60 mg versus placebo, followed by Substudies 2A and 2B (both phase 3), which confirm the effects of these doses or a single dose against placebo. Participants receive daily oral doses approximately at the same time each day, with or without food. Each substudy includes a screening period up to 49 days, a 6-week double-blind treatment phase, a 30-day safety follow-up for those not entering an extension study, and vital status follow-up for early terminators. Participants are evaluated through multiple visits alongside a study partner or caregiver. Assessments include changes in psychotic symptoms measured by the Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions (SAPS-H+D) and the Clinical Global Impression-Severity in ADP context (CGI-S-ADP). Safety monitoring occurs during follow-up, and the total involvement includes screening, treatment, and post-treatment observation phases over several weeks.
CONDITIONS
Brief Title
ACP-204 in Adults With Alzheimer's Disease Psychosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 55 to 95 years living in the community or an institution
- Meets clinical criteria for possible or probable Alzheimer's disease based on 2011 NIA-AA criteria
- Meets revised criteria for psychosis in neurocognitive disorder per International Psychogeriatrics Association
- Has blood-based or documented evidence of amyloid plaque deposition consistent with Alzheimer's disease
- Has a prior MRI or CT brain scan consistent with Alzheimer's diagnosis
- MMSE score between 6 and 24
- Psychotic symptoms present for at least 2 months
- Lives in a stable residence with no plans to change living arrangements
- Has a designated study partner or caregiver
- Able to complete all study visits with a study partner or caregiver
- On a stable dose of cholinesterase inhibitor or memantine if applicable
You will not qualify if you...
- Requires treatment with medications prohibited by the study protocol
- In hospice or receiving end-of-life palliative care, or bedridden
- Requires skilled nursing care
- Psychotic symptoms mainly due to delirium, substance abuse, or medical/psychiatric conditions other than dementia
- History of cerebral amyloid angiopathy, epilepsy, central nervous system tumor, or unexplained fainting
- Atrial fibrillation
- Symptomatic orthostatic hypotension
- Exclusionary abnormal clinical laboratory findings per protocol
- Treatment with anti-tau therapy or donanemab within 2 months before screening
- Additional inclusion/exclusion criteria evaluated at screening to ensure eligibility
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants receive ACP-204 or placebo once daily at approximately the same time each day, with or without food.
Weekly visits for up to 6 weeks
Trial Site Locations
Total: 145 locations
1
Chandler Clinical Trials
Chandler, Arizona, United States, 85224
Actively Recruiting
2
Clinical Endpoint LLC
Scottsdale, Arizona, United States, 85258
Actively Recruiting
3
Advanced Research Center, Inc.
Anaheim, California, United States, 92805
Withdrawn
4
ATP Clinical Research
Costa Mesa, California, United States, 92626
Actively Recruiting
5
Neuro-Pain Medical Center
Fresno, California, United States, 93710
Actively Recruiting
6
National Institute of Clinical Research
Garden Grove, California, United States, 92844
Withdrawn
7
Humanity Clinical Research Corp
Aventura, Florida, United States, 33180
Actively Recruiting
8
Arrow Clinical Trials
Daytona Beach, Florida, United States, 32117
Actively Recruiting
9
First Excellent Research Group
Doral, Florida, United States, 33178
Actively Recruiting
10
New Life Medical Research Center Inc.
Hialeah, Florida, United States, 33012
Actively Recruiting
11
Reliable Clinical Research LLC.
Hialeah, Florida, United States, 33012
Actively Recruiting
12
Homestead Associates in Research Inc.
Miami, Florida, United States, 33032
Actively Recruiting
13
Premier Clinical Research Institute, Inc.
Miami, Florida, United States, 33122
Actively Recruiting
14
Central Miami Medical Institute
Miami, Florida, United States, 33125
Withdrawn
15
Advanced Clinical Research Network, Corp
Miami, Florida, United States, 33135
Actively Recruiting
16
Verus Clinical Research
Miami, Florida, United States, 33135
Actively Recruiting
17
Future Care Solution, LLC
Miami, Florida, United States, 33165
Actively Recruiting
18
MediClear Medical & Research Center, Inc.
Miami, Florida, United States, 33165
Actively Recruiting
19
ABBA Medical Group LLC
Miami, Florida, United States, 33176
Actively Recruiting
20
Visionary Investigators Network
Miami, Florida, United States, 33176
Withdrawn
21
Quantum Clinical Trials
Miami Beach, Florida, United States, 33140
Actively Recruiting
22
New Med Research
Miami Gardens, Florida, United States, 33056
Actively Recruiting
23
Floridian Neuroscience Institutue
Miami Lakes, Florida, United States, 33016
Actively Recruiting
24
Combined Research Orlando Phase I IV
Orlando, Florida, United States, 32807
Actively Recruiting
25
Psych Me Medical Research Inc
Tampa, Florida, United States, 33614
Withdrawn
26
Neuroscience Research Institute
West Palm Beach, Florida, United States, 33407
Actively Recruiting
27
Revive Research Institute, Inc.
Elgin, Illinois, United States, 60123
Withdrawn
28
Grace Research, LLC
Shreveport, Louisiana, United States, 71105
Actively Recruiting
29
Khan Revive Research Institute
Rochester Hills, Michigan, United States, 48307
Withdrawn
30
Alivation Research, LLC
Lincoln, Nebraska, United States, 68526
Withdrawn
31
Dent Neurologic Institute
Amherst, New York, United States, 14226
Withdrawn
32
Finger Lakes Clinical Research
Rochester, New York, United States, 14618
Withdrawn
33
Regional Neurological Associates
The Bronx, New York, United States, 10466
Withdrawn
34
Insight Clinical Trials LLC
Beachwood, Ohio, United States, 44122
Withdrawn
35
Valley Medical Research
Centerville, Ohio, United States, 45459
Withdrawn
36
Abington Neurological Associates
Abington, Pennsylvania, United States, 19001
Actively Recruiting
37
Horizon Clinical Research Group
Cypress, Texas, United States, 77429
Actively Recruiting
38
Prolato Clinical Research Center-Patton
Houston, Texas, United States, 77054
Actively Recruiting
39
University of Texas Health Science Center
Houston, Texas, United States, 77054
Withdrawn
40
Clinical Trial Network LLC
Houston, Texas, United States, 77074
Actively Recruiting
41
Kaleidoscope Clinical Research
Houston, Texas, United States, 77089
Actively Recruiting
42
Steven South Goldstein MD and Associates
Houston, Texas, United States, 77089
Actively Recruiting
43
World Research Link
Pasadena, Texas, United States, 77504
Actively Recruiting
44
R & H Clinical Research Inc.
Stafford, Texas, United States, 77477
Withdrawn
45
Tranquil Clinical Research
Webster, Texas, United States, 77598
Withdrawn
46
L2IP - Instituto de Pesquisas Clínicas Ltda
Brasília, Brazil, 70200-730
Actively Recruiting
47
Hospital Universitario de Brasilia
Brasília, Brazil, 70840-901
Actively Recruiting
48
CECPAR Centro de Estudos Clinicos do Parana
Curitiba, Brazil, 80030-310
Actively Recruiting
49
TrialTech Tecnologia com Pesquisas em Medicamentos
Curitiba, Brazil, 80240-280
Actively Recruiting
50
Inst. de Neurologia de Curitiba Hospital Ecoville
Curitiba, Brazil, 81210-310
Actively Recruiting
51
Instituto Mederi de Pesquisa e Saude
Passo Fundo, Brazil, 99010-120
Actively Recruiting
52
Hospital Moinhos de Vento
Porto Alegre, Brazil, 90035-001
Actively Recruiting
53
Nucleo de Pesquisa Clínica do Rio Grande do Sul
Porto Alegre, Brazil, 90430-001
Withdrawn
54
Ruschel Medicina e Pesquisa Clínica
Rio de Janeiro, Brazil, 22270-060
Actively Recruiting
55
Facili-Centro Integrado de Psiquiatria
São Bernardo do Campo, Brazil, 09726-150
Actively Recruiting
56
BR Trials-Ensaios Clinicos e Consultoria
São Paulo, Brazil, 01236-030
Actively Recruiting
57
Hospital Sao Paulo
São Paulo, Brazil, 04024-002
Actively Recruiting
58
Santa Paula Hospital Clinical Research Center
São Paulo, Brazil, 04550-000
Actively Recruiting
59
Hospital das Clínicas da Faculdade de Medicina USP
São Paulo, Brazil, 05403-000
Withdrawn
60
ET Dr. Ivo Natsov - AIPSMC in Psychiatry
Cherven Bryag, Bulgaria, 5980
Active, Not Recruiting
61
Medical Center Lifemed
Kardzhali, Bulgaria, 6600
Actively Recruiting
62
DCC "Higia"
Pazardzhik, Bulgaria, 4400
Active, Not Recruiting
63
Medical center Medconsult Pleven OOD
Pleven, Bulgaria, 5800
Active, Not Recruiting
64
UMHAT Sv. Georgi EAD
Plovdiv, Bulgaria, 4000
Active, Not Recruiting
65
Medical center Spectar-Plovdic EOOD
Plovdiv, Bulgaria, 4004
Withdrawn
66
Mental Health Centre - Prof. N Shipkovenski EOOD
Sofia, Bulgaria, 1377
Active, Not Recruiting
67
DCC St. Vrach and St. St. Kuzma and Damian OOD
Sofia, Bulgaria, 1408
Active, Not Recruiting
68
UMHAT "Alexandrovska" EAD
Sofia, Bulgaria, 1431
Active, Not Recruiting
69
UMHAT Alexandrovska EAD
Sofia, Bulgaria, 1431
Active, Not Recruiting
70
Medical Center Hera EOOD
Sofia, Bulgaria, 1510
Withdrawn
71
Medical Center Intermediea
Sofia, Bulgaria, 1680
Withdrawn
72
UMHAT Prof. Dr. St. Kirkovich AD
Stara Zagora, Bulgaria, 6003
Withdrawn
73
Psicomed Estudios Medicos
Antofagasta, Chile, 1270244
Actively Recruiting
74
Biomedica Research Group
Santiago, Chile, 7500710
Actively Recruiting
75
Especialidades Medicas L y S
Santiago, Chile, 7560356
Actively Recruiting
76
CIC de la Universidad Catolica CICUC
Santiago, Chile, 8330024
Actively Recruiting
77
BRAIN-SOUL THERAPY s.r.o.
Kladno, Czech Republic, Czechia, 27201
Active, Not Recruiting
78
Ad71 S.R.O.
Prague, Czech Republic, Czechia, 109 00
Active, Not Recruiting
79
Fakultni nemocnice u sv. Anny v Brne
Brno, Czechia, 656 91
Active, Not Recruiting
80
NEUROHK s.r.o
Choceň, Czechia, 56501
Active, Not Recruiting
81
CLINTRIAL s.r.o.
Prague, Czechia, 100 00
Active, Not Recruiting
82
FORBELI s.r.o.
Prague, Czechia, 160 00
Withdrawn
83
INEP medical s.r.o
Prague, Czechia, 186 00
Withdrawn
84
Vestra Clinics s.r.o.
Rychnov nad Kněžnou, Czechia, 516 01
Active, Not Recruiting
85
Hopital Neurologique Bron
Bron, France, 69677
Withdrawn
86
Centre pour Personnes Âgées
Colmar, France, 68000
Withdrawn
87
Centre Memoire Ressources Recherche CMRR
Dijon, France, 21000
Active, Not Recruiting
88
CHU de Limoges-Hopital Dupuytren
Limoges, France, 87042
Active, Not Recruiting
89
Hospices Civils de Lyon HCL
Lyon, France, 69002
Withdrawn
90
Hôpital Lariboisière
Paris, France, 75010
Active, Not Recruiting
91
Hopital BROCA
Paris, France, 75013
Active, Not Recruiting
92
CHU Rouen-Hospital Charles Nicolle
Rouen, France, 76031
Active, Not Recruiting
93
Hopital Purpan
Toulouse, France, 31059
Withdrawn
94
Hôpital La Grave
Toulouse, France, 31059
Active, Not Recruiting
95
CHRU de Tours- Hopital Bretonneau
Tours, France, 37044
Active, Not Recruiting
96
Hôpital de Brabois Adultes
Vandœuvre-lès-Nancy, France, 545000
Active, Not Recruiting
97
ASST degli Spedali Civili di Brescia
Brescia, Italy, 25123
Active, Not Recruiting
98
Neurologia-Fondazione Instituto G. Giglio
Cefalù, Italy, 90015
Active, Not Recruiting
99
IRCCS Neuromed Istituto Neurologico Mediterraneo
Isernia, Italy, 86077
Withdrawn
100
Ospedale San Raffaele
Milan, Italy, 20132
Withdrawn
101
Fondazione Policlinico Uni Campus Bio-Medico di Roma
Roma, Italy, 00128
Active, Not Recruiting
102
Policlinico Universitario Agostino Gemelli
Roma, Italy, 00168
Active, Not Recruiting
103
AOU Policlinico Umberto I
Roma, Italy, 00185
Withdrawn
104
Azienda Ospedaliera Universitaria OO. RR. S.
Salerno, Italy, 84131
Active, Not Recruiting
105
Dipartimento di Neuroscienze Rita Levi Montalcini
Torino, Italy, 10126
Withdrawn
106
Azienda Ospedaliera Card. G. Panico
Tricase, Italy, 73039
Active, Not Recruiting
107
Iecsi S.C.
Monterrey, N.L, Mexico, 64310
Actively Recruiting
108
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey, Nuevo León, Mexico, 64460
Actively Recruiting
109
Hospital Universitario Dr. Gonzalo Valdes Valdes
Coahuila, Mexico, 25000
Actively Recruiting
110
Clinical Research Institute S.C
Estado de México, Mexico, 54055
Actively Recruiting
111
B&B Investigaciones Medicas SC
Mazatlán, Mexico, 82140
Actively Recruiting
112
Health Pharma Professional Research S.A. de C.V.
Mexico City, Mexico, 03100
Actively Recruiting
113
Mexico Centre for Clinical Research S.A de C.V
Mexico City, Mexico, 03100
Actively Recruiting
114
Centro Estudios Clínicos y Esp. Médicas SC CECEM
Nuevo León, Mexico, 64620
Actively Recruiting
115
BIND Investigaciones S.C.
San Luis Potosí City, Mexico, 78213
Actively Recruiting
116
Neurociencias Estudios Clinicos
Sinaloa, Mexico, 80020
Actively Recruiting
117
Centro para el Des de la Med y de Asist Med Esp SC
Sinaloa, Mexico, 80230
Actively Recruiting
118
Clinical Hosp Center Dr Dragisa Misovic Dedinje
Belgrade, Serbia, 11000
Active, Not Recruiting
119
Clinical. Hospital Center Zvezdara
Belgrade, Serbia, 11000
Active, Not Recruiting
120
Institute of Mental Health
Belgrade, Serbia, 11000
Active, Not Recruiting
121
Special Hospital for Cerebrovascular Disease Sveti Sava
Belgrade, Serbia, 11000
Active, Not Recruiting
122
Special Hospital for Psychiatric Diseases
Gornja Toponica, Serbia, 18202
Active, Not Recruiting
123
Spl. Hosp. for Psychiatric Diseases Kovin
Kovin, Serbia, 26220
Withdrawn
124
Janjic University Clinical Center Kragujevac
Kragujevac, Serbia, 34000
Active, Not Recruiting
125
Jovanovic University Clinical Centre of Kragujevac
Kragujevac, Serbia, 34000
Active, Not Recruiting
126
University Clinical Center Kragujevac
Kragujevac, Serbia, 34000
Active, Not Recruiting
127
University Clinical Center Nis
Niš, Serbia, 18000
Active, Not Recruiting
128
Spl. Hosp. for Psychiatric Diseases Sveti Vracevi
Novi Kneževac, Serbia, 23330
Withdrawn
129
Gen. Hosp. Dr Radivoj Simonovic
Sombor, Serbia, 25000
Withdrawn
130
General Hospital Valjevo
Valjevo, Serbia, 14000
Withdrawn
131
Gachon University Gil Medical Center
Incheon, South Korea, 21565
Actively Recruiting
132
Inha University Hospital
Incheon, South Korea, 22332
Actively Recruiting
133
Korea University Anam Hospital
Seoul, South Korea, 02841
Actively Recruiting
134
Eunpyeong St. Mary's Hospital
Seoul, South Korea, 03312
Withdrawn
135
Hanyang University Seoul Hospital
Seoul, South Korea, 04763
Withdrawn
136
Konkuk University Medical Center
Seoul, South Korea, 05030
Withdrawn
137
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
138
SMG-SNU Boramae Medical Center
Seoul, South Korea, 07061
Actively Recruiting
139
Hospital Universitario Virgen Macarena
Seville, Spain, 41009
Active, Not Recruiting
140
Hospital Provincial de Zamora
Zamora, Spain, 49021
Active, Not Recruiting
141
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan, 80756
Actively Recruiting
142
E-DA Hospital
Kaohsiung City, Taiwan
Actively Recruiting
143
Taipei Medical University-Shuang Ho Hospital
New Taipei City, Taiwan, 23561
Withdrawn
144
National Cheng Kung University Hospital
Tainan, Taiwan, 704
Withdrawn
145
National Taiwan University Hospital
Taipei, Taiwan, 10002
Actively Recruiting
Research Team
C
Christine Murphy
K
Kristen White
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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