Alzheimer's Disease PsychosisPhase 2/3NCT06159673
ACP-204 in Adults With Alzheimer's Disease Psychosis
A Phase 2/3 study testing ACP-204 in people with Alzheimer's Disease Psychosis, run by ACADIA Pharmaceuticals Inc. at 154 sites in 12 countries.
Trial summary
This is a master protocol for 3 independent, seamlessly enrolling, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies in patients with ADP Substudy 1 (Phase 2) will evaluate efficacy and dose response of ACP-204 30 and 60 mg vs placebo. This substudy will be initiated first. Read more about this study
- Who is it for?
- Ages 55 to 95 years
- Conditions the study is for
- Alzheimer's Disease Psychosis
- What is being tested?
- ACP-204
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,074 participants
- Where
- 154 sitesin 12 countries
- Study dates
- 14 Nov 2023to Feb 2028
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is male or female and ≥55 and ≤95 years of age living in the community or in an institutionalized setting
- Meets clinical criteria for possible or probable AD based on the 2011 National Institute on Aging-Alzheimer Association (NIA-AA) criteria
- Meets the revised criteria for psychosis in major or mild neurocognitive disorder established by the International Psychogeriatrics Association (IPA)
- Has either blood-based biomarker or documented evidence (e.g. positron emission tomography, cerebrospinal fluid biomarker) indicating amyloid plaque deposition and neuropathologic change consistent with AD
- Has a prior magnetic resonance imaging or computed tomography scan of the brain that is consistent with the diagnosis of AD
- Meets revised criteria for psychosis in major or mild neurocognitive disorder as per International Psychogeriatrics Association
Show all 12Show fewer
- MMSE score ≥6 and ≤24
- Psychotic symptoms for at least 2 months
- Lives in a stable place of residence and there are no plans to change living arrangements
- Has a designated study partner/caregiver
- Able to complete all study visits with a study partner/caregiver
- Must be on a stable dose of cholinesterase inhibitor or memantine, if applicable
Who cannot join
- Requires treatment with a medication prohibited by the protocol
- Is in hospice and receiving end-of-life palliative care, or has become bedridden
- Requires skilled nursing care
- Psychotic symptoms that are primarily attributable to delirium, substance abuse, or a medical or psychiatric condition other than dementia
- Known history of cerebral amyloid angiopathy, epilepsy, central nervous system neoplasm, or unexplained syncope
- Atrial fibrillation
Show all 10Show fewer
- Symptomatic orthostatic hypotension
- Protocol-defined exclusionary clinical laboratory findings
- Treatment with anti-tau therapy or donanemab within 2 months prior to Screening
- Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met.
Trial locations and contacts
154 sites in 12 countries. Contact the study team or a site near you to ask about taking part.
154 sites in 12 countries
United States52 sites, 35 recruiting
- Recruiting
Abington Neurological Associates
Abington, Pennsylvania, 19001
- Withdrawn
Dent Neurologic Institute
Amherst, New York, 14226
- Withdrawn
Advanced Research Center, Inc.
Anaheim, California, 92805
- Recruiting
Agile Clinical Research Trials LLC
Atlanta, Georgia, 30328
- Recruiting
Humanity Clinical Research Corp
Aventura, Florida, 33180
- Withdrawn
Insight Clinical Trials LLC
Beachwood, Ohio, 44122
- Withdrawn
Valley Medical Research
Centerville, Ohio, 45459
- Withdrawn
Chandler Clinical Trials
Chandler, Arizona, 85224
- Recruiting
ATP Clinical Research
Costa Mesa, California, 92626
- Recruiting
Horizon Clinical Research Group
Cypress, Texas, 77429
- Recruiting
NDx Clinical Research Inc.
Dayton, Ohio, 45459
- Recruiting
Arrow Clinical Trials
Daytona Beach, Florida, 32117
- Recruiting
First Excellent Research Group
Doral, Florida, 33178
- Withdrawn
Revive Research Institute, Inc.
Elgin, Illinois, 60123
- Recruiting
Neuro-Pain Medical Center
Fresno, California, 93710
- Recruiting
CBH Health LLC, dba CenExcel Gaithersburg
Gaithersburg, Maryland, 20877
- Terminated
National Institute of Clinical Research
Garden Grove, California, 92844
- Recruiting
New Life Medical Research Center Inc.
Hialeah, Florida, 33012
- Recruiting
Reliable Clinical Research LLC.
Hialeah, Florida, 33012
- Recruiting
Prolato Clinical Research Center-Patton
Houston, Texas, 77054
- Terminated
University of Texas Health Science Center
Houston, Texas, 77054
- Recruiting
Clinical Trial Network LLC
Houston, Texas, 77074
- Recruiting
Kaleidoscope Clinical Research
Houston, Texas, 77089
- Recruiting
Steven South Goldstein MD and Associates
Houston, Texas, 77089
- Withdrawn
Alivation Research, LLC
Lincoln, Nebraska, 68526
- Recruiting
Homestead Associates in Research Inc.
Miami, Florida, 33032
- Recruiting
Premier Clinical Research Institute, Inc.
Miami, Florida, 33122
- Withdrawn
Central Miami Medical Institute
Miami, Florida, 33125
- Recruiting
Advanced Clinical Research Network, Corp
Miami, Florida, 33135
- Recruiting
Verus Clinical Research
Miami, Florida, 33135
- Recruiting
Future Care Solution, LLC
Miami, Florida, 33165
- Recruiting
MediClear Medical & Research Center, Inc.
Miami, Florida, 33165
- Recruiting
ABBA Medical Group LLC
Miami, Florida, 33176
- Withdrawn
Visionary Investigators Network
Miami, Florida, 33176
- Recruiting
Quantum Clinical Trials
Miami Beach, Florida, 33140
- Recruiting
New Med Research
Miami Gardens, Florida, 33056
- Recruiting
Floridian Neuroscience Institutue
Miami Lakes, Florida, 33016
- Recruiting
Combined Research Orlando Phase I IV
Orlando, Florida, 32807
- Recruiting
Havana Research Institute LLC
Pasadena, California, 91105-3264
- Recruiting
Quantum Clinical Research, Inc.
Pasadena, California, 91106
- Recruiting
World Research Link
Pasadena, Texas, 77504
- Withdrawn
Finger Lakes Clinical Research
Rochester, New York, 14618
- Withdrawn
Khan Revive Research Institute
Rochester Hills, Michigan, 48307
- Recruiting
Clinical Endpoint LLC
Scottsdale, Arizona, 85258
- Recruiting
Grace Research, LLC
Shreveport, Louisiana, 71105
- Recruiting
Tekton Research, LLC
St Louis, Missouri, 63128
- Withdrawn
R & H Clinical Research Inc.
Stafford, Texas, 77477
- Recruiting
SUNY Upstate Medical University
Syracuse, New York, 13210
- Withdrawn
Psych Me Medical Research Inc
Tampa, Florida, 33614
- Withdrawn
Regional Neurological Associates
The Bronx, New York, 10466
- Withdrawn
Tranquil Clinical Research
Webster, Texas, 77598
- Recruiting
Neuroscience Research Institute
West Palm Beach, Florida, 33407
Brazil15 sites, 13 recruiting
- Recruiting
L2IP - Instituto de Pesquisas Clínicas Ltda
Brasília, 70200-730
- Recruiting
Hospital Universitario de Brasilia
Brasília, 70840-901
- Recruiting
CECPAR Centro de Estudos Clinicos do Parana
Curitiba, 80030-310
- Recruiting
TrialTech Tecnologia com Pesquisas em Medicamentos
Curitiba, 80240-280
- Recruiting
Inst. de Neurologia de Curitiba Hospital Ecoville
Curitiba, 81210-310
- Recruiting
Clinica Neurologica e Neurocirurgica de Joinville
Joinville, Santa Catarina, 89202-190
- Recruiting
Instituto Mederi de Pesquisa e Saude
Passo Fundo, 99010-120
- Recruiting
Hospital Moinhos de Vento
Porto Alegre, 90035-001
- Withdrawn
Nucleo de Pesquisa Clínica do Rio Grande do Sul
Porto Alegre, 90430-001
- Recruiting
Ruschel Medicina e Pesquisa Clínica
Rio de Janeiro, 22270-060
- Recruiting
Facili-Centro Integrado de Psiquiatria
São Bernardo do Campo, 09726-150
- Recruiting
BR Trials-Ensaios Clinicos e Consultoria
São Paulo, 01236-030
- Recruiting
Hospital Sao Paulo
São Paulo, 04024-002
- Recruiting
Santa Paula Hospital Clinical Research Center
São Paulo, 04550-000
- Withdrawn
Hospital das Clínicas da Faculdade de Medicina USP
São Paulo, 05403-000
Serbia14 sites, 1 recruiting
- Active, not recruiting
Clinical Hosp Center Dr Dragisa Misovic Dedinje
Belgrade, 11000
- Active, not recruiting
Clinical. Hospital Center Zvezdara
Belgrade, 11000
- Active, not recruiting
Institute of Mental Health
Belgrade, 11000
- Active, not recruiting
Special Hospital for Cerebrovascular Disease Sveti Sava
Belgrade, 11000
- Recruiting
University Clinic Centre of Serbia
Belgrade, 11000
- Active, not recruiting
Special Hospital for Psychiatric Diseases
Gornja Toponica, 18202
- Terminated
Spl. Hosp. for Psychiatric Diseases Kovin
Kovin, 26220
- Active, not recruiting
Janjic University Clinical Center Kragujevac
Kragujevac, 34000
- Active, not recruiting
Jovanovic University Clinical Centre of Kragujevac
Kragujevac, 34000
- Active, not recruiting
University Clinical Center Kragujevac
Kragujevac, 34000
- Active, not recruiting
University Clinical Center Nis
Niš, 18000
- Withdrawn
Spl. Hosp. for Psychiatric Diseases Sveti Vracevi
Novi Kneževac, 23330
- Withdrawn
Gen. Hosp. Dr Radivoj Simonovic
Sombor, 25000
- Withdrawn
General Hospital Valjevo
Valjevo, 14000
Bulgaria13 sites
- Active, not recruiting
ET Dr. Ivo Natsov - AIPSMC in Psychiatry
Cherven Bryag, 5980
- Withdrawn
Medical Center Lifemed
Kardzhali, 6600
- Active, not recruiting
DCC "Higia"
Pazardzhik, 4400
- Active, not recruiting
Medical center Medconsult Pleven OOD
Pleven, 5800
- Withdrawn
UMHAT Sv. Georgi EAD
Plovdiv, 4000
- Withdrawn
Medical center Spectar-Plovdic EOOD
Plovdiv, 4004
- Active, not recruiting
Mental Health Centre - Prof. N Shipkovenski EOOD
Sofia, 1377
- Active, not recruiting
DCC St. Vrach and St. St. Kuzma and Damian OOD
Sofia, 1408
- Active, not recruiting
UMHAT "Alexandrovska" EAD
Sofia, 1431
- Active, not recruiting
UMHAT Alexandrovska EAD
Sofia, 1431
- Withdrawn
Medical Center Hera EOOD
Sofia, 1510
- Withdrawn
Medical Center Intermedica
Sofia, 1680
- Withdrawn
UMHAT Prof. Dr. St. Kirkovich AD
Stara Zagora, 6003
France12 sites
- Withdrawn
Hopital Neurologique Bron
Bron, 69677
- Withdrawn
Centre pour Personnes Âgées
Colmar, 68000
- Active, not recruiting
Centre Memoire Ressources Recherche CMRR
Dijon, 21000
- Active, not recruiting
CHU de Limoges-Hopital Dupuytren
Limoges, 87042
- Withdrawn
Hospices Civils de Lyon HCL
Lyon, 69002
- Active, not recruiting
Hôpital Lariboisière
Paris, 75010
- Active, not recruiting
Hopital BROCA
Paris, 75013
- Active, not recruiting
CHU Rouen-Hospital Charles Nicolle
Rouen, 76031
- Withdrawn
Hopital Purpan
Toulouse, 31059
- Active, not recruiting
Hôpital La Grave
Toulouse, 31059
- Active, not recruiting
CHRU de Tours- Hopital Bretonneau
Tours, 37044
- Active, not recruiting
Hôpital de Brabois Adultes
Vandœuvre-lès-Nancy, 545000
Mexico11 sites, 11 recruiting
- Recruiting
Hospital Universitario Dr. Gonzalo Valdes Valdes
Coahuila, 25000
- Recruiting
Clinical Research Institute S.C
Estado de México, 54055
- Recruiting
B&B Investigaciones Medicas SC
Mazatlán, 82140
- Recruiting
Health Pharma Professional Research S.A. de C.V.
Mexico City, 03100
- Recruiting
Mexico Centre for Clinical Research S.A de C.V
Mexico City, 03100
- Recruiting
Iecsi S.C.
Monterrey, N.L, 64310
- Recruiting
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey, Nuevo León, 64460
- Recruiting
Centro Estudios Clínicos y Esp. Médicas SC CECEM
Nuevo León, 64620
- Recruiting
BIND Investigaciones S.C.
San Luis Potosí City, 78213
- Recruiting
Neurociencias Estudios Clinicos
Sinaloa, 80020
- Recruiting
Centro para el Des de la Med y de Asist Med Esp SC
Sinaloa, 80230
Italy10 sites
- Active, not recruiting
ASST degli Spedali Civili di Brescia
Brescia, 25123
- Active, not recruiting
Neurologia-Fondazione Instituto G. Giglio
Cefalù, 90015
- Withdrawn
IRCCS Neuromed Istituto Neurologico Mediterraneo
Isernia, 86077
- Withdrawn
Ospedale San Raffaele
Milan, 20132
- Active, not recruiting
Fondazione Policlinico Uni Campus Bio-Medico di Roma
Roma, 00128
- Active, not recruiting
Policlinico Universitario Agostino Gemelli
Roma, 00168
- Withdrawn
AOU Policlinico Umberto I
Roma, 00185
- Active, not recruiting
Azienda Ospedaliera Universitaria OO. RR. S.
Salerno, 84131
- Withdrawn
Dipartimento di Neuroscienze Rita Levi Montalcini
Torino, 10126
- Active, not recruiting
Azienda Ospedaliera Card. G. Panico
Tricase, 73039
Czechia8 sites
- Active, not recruiting
Fakultni nemocnice u sv. Anny v Brne
Brno, 656 91
- Active, not recruiting
NEUROHK s.r.o
Choceň, 56501
- Active, not recruiting
BRAIN-SOUL THERAPY s.r.o.
Kladno, Czech Republic, 27201
- Active, not recruiting
Ad71 S.R.O.
Prague, Czech Republic, 109 00
- Active, not recruiting
CLINTRIAL s.r.o.
Prague, 100 00
- Withdrawn
FORBELI s.r.o.
Prague, 160 00
- Withdrawn
INEP medical s.r.o
Prague, 186 00
- Active, not recruiting
Vestra Clinics s.r.o.
Rychnov nad Kněžnou, 516 01
South Korea8 sites, 5 recruiting
- Recruiting
Gachon University Gil Medical Center
Incheon, 21565
- Recruiting
Inha University Hospital
Incheon, 22332
- Recruiting
Korea University Anam Hospital
Seoul, 02841
- Terminated
Eunpyeong St. Mary's Hospital
Seoul, 03312
- Terminated
Hanyang University Seoul Hospital
Seoul, 04763
- Withdrawn
Konkuk University Medical Center
Seoul, 05030
- Recruiting
Samsung Medical Center
Seoul, 06351
- Recruiting
SMG-SNU Boramae Medical Center
Seoul, 07061
Taiwan5 sites, 3 recruiting
- Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 80756
- Recruiting
E-DA Hospital
Kaohsiung City
- Withdrawn
Taipei Medical University-Shuang Ho Hospital
New Taipei City, 23561
- Withdrawn
National Cheng Kung University Hospital
Tainan, 704
- Recruiting
National Taiwan University Hospital
Taipei, 10002
Chile4 sites, 4 recruiting
- Recruiting
Psicomed Estudios Medicos
Antofagasta, 1270244
- Recruiting
Biomedica Research Group
Santiago, 7500710
- Recruiting
Especialidades Medicas L y S
Santiago, 7560356
- Recruiting
CIC de la Universidad Catolica CICUC
Santiago, 8330024
Spain2 sites
- Active, not recruiting
Hospital Universitario Virgen Macarena
Seville, 41009
- Active, not recruiting
Hospital Provincial de Zamora
Zamora, 49021
About this study
Official title: A Master Protocol for Three Independent, Seamlessly Enrolling, Double-blind, Placebo-controlled Efficacy and Safety Studies of ACP-204 in Adults With Alzheimer's Disease Psychosis
This is a master protocol for 3 independent, seamlessly enrolling, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies in patients with ADP
- Substudy 1 (Phase 2) will evaluate efficacy and dose response of ACP-204 30 and 60 mg vs placebo. This substudy will be initiated first.
- Substudies 2A and 2B (both: Phase 3) will be confirmatory studies of either both doses (ACP-204 30 and 60 mg, respectively) or a single dose from Part 1 vs placebo. Substudies 2A and 2B will be performed independently of each other and will commence after enrollment of Part 1.
Read more
All 3 substudies will be analyzed independently of each other.
Each substudy individually will consist of a screening period (up to 49 days); a double-blind treatment period (6 weeks); a safety follow-up period (30 days) for patients not rolling over into an open-label extension study; and vital status follow-up (for patients who terminated their substudy early).
- Conditions
- Alzheimer's Disease Psychosis
- Being tested
- ACP-204, Placebo
- Keywords
- Alzheimer's disease psychosis, Hallucinations, Delusions
- Medical subject headings
- Hallucinations, Delusions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACP-204Drug
ACP-204 is a potent and selective antagonist/inverse agonist of 5-hydroxytryptamine (serotonin) receptor subtype 2A.
PlaceboDrug
ACP-204 matching placebo
| Study group | Role | What they receive |
|---|---|---|
| ACP-204 30 mg | Experimental | Administration once daily at approximately the same time of day, with or without food Receives: Drug: ACP-204 |
| ACP-204 60 mg | Experimental | Administration once daily at approximately the same time of day, with or without food Receives: Drug: ACP-204 |
| Placebo | Placebo comparator | Administration once daily at approximately the same time of day, with or without food Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions subscales (SAPS-H+D) total score change from baseline (Substudies 1, 2A, 2B)
The SAPS-H+D subscales are a measure of two psychotic symptoms: hallucinations and delusions. The SAPS-H+D total score is the sum of the scores of the Hallucinations and Delusions subscales. The hallucinations domain score (SAPS-H) is the sum of the 7 hallucinations item scores, and the delusions domain core (SAPS-D) is the sum of the 13 delusions item scores.
Measured: From baseline to Week 6
Secondary outcomes (1)
Clinical Global Impression-Severity in the ADP context (CGI-S-ADP) score
The CGI-S scale is a clinician-rated, 7-point scale that is designed to rate the severity of the subject's symptoms at the time of assessment using the Investigator's judgment and past experience with subjects who have the same disorder. The CGI-S-ADP scale is the CGI-S scale applied in the ADP context, in which hallucinations and delusions are the symptoms of interest.
Measured: Baseline to Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start14 Nov 2023
- Primary completionJan 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's Disease PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,074 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ACADIA Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06159673
- Sponsor's protocol ID
- ACP-204-006
- Status last verified
- Jun 2026
- First submitted
- 27 Nov 2023
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No