ACP-204 hos voksne med psykose fra Alzheimers sygdom
3. november 2026 opdateret af: ACADIA Pharmaceuticals Inc.
En masterprotokol for tre uafhængige, problemfrit indskrivende, dobbeltblindede, placebokontrollerede effektivitets- og sikkerhedsundersøgelser af ACP-204 hos voksne med Alzheimers sygdomspsykose
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.
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).
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
1074
Fase
- Fase 2
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Christine Murphy
- Telefonnummer: 858-465-7480
- E-mail: cmurphy@acadia-pharm.com
Undersøgelse Kontakt Backup
- Navn: Kristen White
- Telefonnummer: 813-838-6468
- E-mail: kristen.white@acadia-pharm.com
Studiesteder
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Brasília, Brasilien, 70840-901
- Rekruttering
- Hospital Universitario de Brasilia
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Brasília, Brasilien, 70200-730
- Rekruttering
- L2IP - Instituto de Pesquisas Clínicas Ltda
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Curitiba, Brasilien, 81210-310
- Rekruttering
- Inst. de Neurologia de Curitiba Hospital Ecoville
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Curitiba, Brasilien, 80240-280
- Rekruttering
- TrialTech Tecnologia com Pesquisas em Medicamentos
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Curitiba, Brasilien, 80030-310
- Rekruttering
- CECPAR Centro de Estudos Clinicos do Parana
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Passo Fundo, Brasilien, 99010-120
- Rekruttering
- Instituto Mederi de Pesquisa e Saude
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Porto Alegre, Brasilien, 90035-001
- Rekruttering
- Hospital Moinhos de Vento
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Porto Alegre, Brasilien, 90430-001
- Trukket tilbage
- Nucleo de Pesquisa Clínica do Rio Grande do Sul
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Rio de Janeiro, Brasilien, 22270-060
- Rekruttering
- Ruschel Medicina e Pesquisa Clínica
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São Bernardo do Campo, Brasilien, 09726-150
- Rekruttering
- Facili-Centro Integrado de Psiquiatria
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São Paulo, Brasilien, 04024-002
- Rekruttering
- Hospital Sao Paulo
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São Paulo, Brasilien, 01236-030
- Rekruttering
- BR Trials-Ensaios Clinicos e Consultoria
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São Paulo, Brasilien, 05403-000
- Trukket tilbage
- Hospital das Clínicas da Faculdade de Medicina USP
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São Paulo, Brasilien, 04550-000
- Rekruttering
- Santa Paula Hospital Clinical Research Center
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Santa Catarina
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Joinville, Santa Catarina, Brasilien, 89202-190
- Rekruttering
- Clinica Neurologica e Neurocirurgica de Joinville
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-
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Cherven Bryag, Bulgarien, 5980
- Aktiv, ikke rekrutterende
- ET Dr. Ivo Natsov - AIPSMC in Psychiatry
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Kardzhali, Bulgarien, 6600
- Trukket tilbage
- Medical Center Lifemed
-
Pazardzhik, Bulgarien, 4400
- Aktiv, ikke rekrutterende
- DCC "Higia"
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Pleven, Bulgarien, 5800
- Aktiv, ikke rekrutterende
- Medical center Medconsult Pleven OOD
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Plovdiv, Bulgarien, 4004
- Trukket tilbage
- Medical center Spectar-Plovdic EOOD
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Plovdiv, Bulgarien, 4000
- Trukket tilbage
- UMHAT Sv. Georgi EAD
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Sofia, Bulgarien, 1510
- Trukket tilbage
- Medical Center Hera EOOD
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Sofia, Bulgarien, 1377
- Aktiv, ikke rekrutterende
- Mental Health Centre - Prof. N Shipkovenski EOOD
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Sofia, Bulgarien, 1408
- Aktiv, ikke rekrutterende
- DCC St. Vrach and St. St. Kuzma and Damian OOD
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Sofia, Bulgarien, 1431
- Aktiv, ikke rekrutterende
- UMHAT "Alexandrovska" EAD
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Sofia, Bulgarien, 1431
- Aktiv, ikke rekrutterende
- UMHAT Alexandrovska EAD
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Sofia, Bulgarien, 1680
- Trukket tilbage
- Medical Center Intermedica
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Stara Zagora, Bulgarien, 6003
- Trukket tilbage
- UMHAT Prof. Dr. St. Kirkovich AD
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Antofagasta, Chile, 1270244
- Rekruttering
- Psicomed Estudios Medicos
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Santiago, Chile, 7560356
- Rekruttering
- Especialidades Medicas L y S
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Santiago, Chile, 8330024
- Rekruttering
- CIC de la Universidad Catolica CICUC
-
Santiago, Chile, 7500710
- Rekruttering
- Biomedica Research Group
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Arizona
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Chandler, Arizona, Forenede Stater, 85224
- Trukket tilbage
- Chandler Clinical Trials
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Scottsdale, Arizona, Forenede Stater, 85258
- Rekruttering
- Clinical Endpoint LLC
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California
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Anaheim, California, Forenede Stater, 92805
- Trukket tilbage
- Advanced Research Center, Inc.
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Costa Mesa, California, Forenede Stater, 92626
- Rekruttering
- ATP Clinical Research
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Fresno, California, Forenede Stater, 93710
- Rekruttering
- Neuro-Pain Medical Center
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Garden Grove, California, Forenede Stater, 92844
- Afsluttet
- National Institute of Clinical Research
-
Pasadena, California, Forenede Stater, 91105-3264
- Rekruttering
- Havana Research Institute LLC
-
Pasadena, California, Forenede Stater, 91106
- Rekruttering
- Quantum Clinical Research, Inc.
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Florida
-
Aventura, Florida, Forenede Stater, 33180
- Rekruttering
- Humanity Clinical Research Corp
-
Daytona Beach, Florida, Forenede Stater, 32117
- Rekruttering
- Arrow Clinical Trials
-
Doral, Florida, Forenede Stater, 33178
- Rekruttering
- First Excellent Research Group
-
Hialeah, Florida, Forenede Stater, 33012
- Rekruttering
- New Life Medical Research Center Inc.
-
Hialeah, Florida, Forenede Stater, 33012
- Rekruttering
- Reliable Clinical Research LLC.
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Miami, Florida, Forenede Stater, 33176
- Trukket tilbage
- Visionary Investigators Network
-
Miami, Florida, Forenede Stater, 33122
- Rekruttering
- Premier Clinical Research Institute, Inc.
-
Miami, Florida, Forenede Stater, 33165
- Rekruttering
- MediClear Medical & Research Center, Inc.
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Miami, Florida, Forenede Stater, 33032
- Rekruttering
- Homestead Associates in Research Inc.
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Miami, Florida, Forenede Stater, 33165
- Rekruttering
- Future Care Solution, LLC
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Miami, Florida, Forenede Stater, 33135
- Rekruttering
- Verus Clinical Research
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Miami, Florida, Forenede Stater, 33135
- Rekruttering
- Advanced Clinical Research Network, Corp
-
Miami, Florida, Forenede Stater, 33125
- Trukket tilbage
- Central Miami Medical Institute
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Miami, Florida, Forenede Stater, 33176
- Rekruttering
- ABBA Medical Group LLC
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Miami Beach, Florida, Forenede Stater, 33140
- Rekruttering
- Quantum Clinical Trials
-
Miami Gardens, Florida, Forenede Stater, 33056
- Rekruttering
- New Med Research
-
Miami Lakes, Florida, Forenede Stater, 33016
- Rekruttering
- Floridian Neuroscience Institutue
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Orlando, Florida, Forenede Stater, 32807
- Rekruttering
- Combined Research Orlando Phase I IV
-
Tampa, Florida, Forenede Stater, 33614
- Trukket tilbage
- Psych Me Medical Research Inc
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West Palm Beach, Florida, Forenede Stater, 33407
- Rekruttering
- Neuroscience Research Institute
-
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Georgia
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Atlanta, Georgia, Forenede Stater, 30328
- Rekruttering
- Agile Clinical Research Trials LLC
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Illinois
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Elgin, Illinois, Forenede Stater, 60123
- Trukket tilbage
- Revive Research Institute, Inc.
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Louisiana
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Shreveport, Louisiana, Forenede Stater, 71105
- Rekruttering
- Grace Research, LLC
-
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Maryland
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Gaithersburg, Maryland, Forenede Stater, 20877
- Rekruttering
- CBH Health LLC, dba CenExcel Gaithersburg
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Michigan
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Rochester Hills, Michigan, Forenede Stater, 48307
- Trukket tilbage
- Khan Revive Research Institute
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Missouri
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St Louis, Missouri, Forenede Stater, 63128
- Rekruttering
- Tekton Research, LLC
-
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Nebraska
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Lincoln, Nebraska, Forenede Stater, 68526
- Trukket tilbage
- Alivation Research, LLC
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New Jersey
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Marlton, New Jersey, Forenede Stater, 08053
- Rekruttering
- Advanced Memory Research Institute of New Jersey
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New York
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Amherst, New York, Forenede Stater, 14226
- Trukket tilbage
- Dent Neurologic Institute
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Rochester, New York, Forenede Stater, 14618
- Trukket tilbage
- Finger Lakes Clinical Research
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Syracuse, New York, Forenede Stater, 13210
- Rekruttering
- SUNY Upstate Medical University
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The Bronx, New York, Forenede Stater, 10466
- Trukket tilbage
- Regional Neurological Associates
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Ohio
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Beachwood, Ohio, Forenede Stater, 44122
- Trukket tilbage
- Insight Clinical Trials LLC
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Centerville, Ohio, Forenede Stater, 45459
- Trukket tilbage
- Valley Medical Research
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Dayton, Ohio, Forenede Stater, 45459
- Rekruttering
- NDx Clinical Research Inc.
-
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Pennsylvania
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Abington, Pennsylvania, Forenede Stater, 19001
- Rekruttering
- Abington Neurological Associates
-
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Texas
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Cypress, Texas, Forenede Stater, 77429
- Rekruttering
- Horizon Clinical Research Group
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Houston, Texas, Forenede Stater, 77074
- Rekruttering
- Clinical Trial Network LLC
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Houston, Texas, Forenede Stater, 77089
- Rekruttering
- Kaleidoscope Clinical Research
-
Houston, Texas, Forenede Stater, 77054
- Rekruttering
- Prolato Clinical Research Center-Patton
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Houston, Texas, Forenede Stater, 77089
- Rekruttering
- Steven South Goldstein MD and Associates
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Houston, Texas, Forenede Stater, 77054
- Afsluttet
- University of Texas Health Science Center
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Pasadena, Texas, Forenede Stater, 77504
- Rekruttering
- World Research Link
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Stafford, Texas, Forenede Stater, 77477
- Trukket tilbage
- R & H Clinical Research Inc.
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Webster, Texas, Forenede Stater, 77598
- Trukket tilbage
- Tranquil Clinical Research
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-
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Bron, Frankrig, 69677
- Trukket tilbage
- Hopital Neurologique Bron
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Colmar, Frankrig, 68000
- Trukket tilbage
- Centre pour Personnes Âgées
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Dijon, Frankrig, 21000
- Aktiv, ikke rekrutterende
- Centre Memoire Ressources Recherche CMRR
-
Limoges, Frankrig, 87042
- Aktiv, ikke rekrutterende
- CHU de Limoges-Hopital Dupuytren
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Lyon, Frankrig, 69002
- Trukket tilbage
- Hospices Civils de Lyon HCL
-
Paris, Frankrig, 75010
- Aktiv, ikke rekrutterende
- Hôpital Lariboisière
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Paris, Frankrig, 75013
- Aktiv, ikke rekrutterende
- Hopital BROCA
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Rouen, Frankrig, 76031
- Aktiv, ikke rekrutterende
- CHU Rouen-Hospital Charles Nicolle
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Toulouse, Frankrig, 31059
- Trukket tilbage
- Hopital Purpan
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Toulouse, Frankrig, 31059
- Aktiv, ikke rekrutterende
- Hôpital La Grave
-
Tours, Frankrig, 37044
- Aktiv, ikke rekrutterende
- CHRU de Tours- Hopital Bretonneau
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Vandœuvre-lès-Nancy, Frankrig, 545000
- Aktiv, ikke rekrutterende
- Hôpital de Brabois Adultes
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Brescia, Italien, 25123
- Aktiv, ikke rekrutterende
- ASST degli Spedali Civili di Brescia
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Cefalù, Italien, 90015
- Aktiv, ikke rekrutterende
- Neurologia-Fondazione Instituto G. Giglio
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Isernia, Italien, 86077
- Trukket tilbage
- IRCCS Neuromed Istituto Neurologico Mediterraneo
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Milan, Italien, 20132
- Trukket tilbage
- Ospedale San Raffaele
-
Roma, Italien, 00168
- Aktiv, ikke rekrutterende
- Policlinico Universitario Agostino Gemelli
-
Roma, Italien, 00185
- Trukket tilbage
- AOU Policlinico Umberto I
-
Roma, Italien, 00128
- Aktiv, ikke rekrutterende
- Fondazione Policlinico Uni Campus Bio-Medico di Roma
-
Salerno, Italien, 84131
- Aktiv, ikke rekrutterende
- Azienda Ospedaliera Universitaria OO. RR. S.
-
Torino, Italien, 10126
- Trukket tilbage
- Dipartimento di Neuroscienze Rita Levi Montalcini
-
Tricase, Italien, 73039
- Aktiv, ikke rekrutterende
- Azienda Ospedaliera Card. G. Panico
-
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Coahuila, Mexico, 25000
- Rekruttering
- Hospital Universitario Dr. Gonzalo Valdes Valdes
-
Estado de México, Mexico, 54055
- Rekruttering
- Clinical Research Institute S.C
-
Mazatlán, Mexico, 82140
- Rekruttering
- B&B Investigaciones Medicas SC
-
Mexico City, Mexico, 03100
- Rekruttering
- Mexico Centre for Clinical Research S.A de C.V
-
Mexico City, Mexico, 03100
- Rekruttering
- Health Pharma Professional Research S.A. de C.V.
-
Nuevo León, Mexico, 64620
- Rekruttering
- Centro Estudios Clínicos y Esp. Médicas SC CECEM
-
San Luis Potosí City, Mexico, 78213
- Rekruttering
- BIND Investigaciones S.C.
-
Sinaloa, Mexico, 80020
- Rekruttering
- Neurociencias Estudios Clinicos
-
Sinaloa, Mexico, 80230
- Rekruttering
- Centro para el Des de la Med y de Asist Med Esp SC
-
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N.L
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Monterrey, N.L, Mexico, 64310
- Rekruttering
- Iecsi S.C.
-
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Nuevo León
-
Monterrey, Nuevo León, Mexico, 64460
- Rekruttering
- Hospital Universitario Dr. Jose Eleuterio Gonzalez
-
-
-
-
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Belgrade, Serbien, 11000
- Aktiv, ikke rekrutterende
- Institute of Mental Health
-
Belgrade, Serbien, 11000
- Aktiv, ikke rekrutterende
- Clinical Hosp Center Dr Dragisa Misovic Dedinje
-
Belgrade, Serbien, 11000
- Aktiv, ikke rekrutterende
- Clinical. Hospital Center Zvezdara
-
Belgrade, Serbien, 11000
- Aktiv, ikke rekrutterende
- Special Hospital for Cerebrovascular Disease Sveti Sava
-
Belgrade, Serbien, 11000
- Rekruttering
- University Clinic Centre of Serbia
-
Gornja Toponica, Serbien, 18202
- Aktiv, ikke rekrutterende
- Special Hospital for Psychiatric Diseases
-
Kovin, Serbien, 26220
- Afsluttet
- Spl. Hosp. for Psychiatric Diseases Kovin
-
Kragujevac, Serbien, 34000
- Aktiv, ikke rekrutterende
- Janjic University Clinical Center Kragujevac
-
Kragujevac, Serbien, 34000
- Aktiv, ikke rekrutterende
- Jovanovic University Clinical Centre of Kragujevac
-
Kragujevac, Serbien, 34000
- Aktiv, ikke rekrutterende
- University Clinical Center Kragujevac
-
Niš, Serbien, 18000
- Aktiv, ikke rekrutterende
- University Clinical Center Nis
-
Novi Kneževac, Serbien, 23330
- Trukket tilbage
- Spl. Hosp. for Psychiatric Diseases Sveti Vracevi
-
Sombor, Serbien, 25000
- Trukket tilbage
- Gen. Hosp. Dr Radivoj Simonovic
-
Valjevo, Serbien, 14000
- Trukket tilbage
- General Hospital Valjevo
-
-
-
-
-
Seville, Spanien, 41009
- Aktiv, ikke rekrutterende
- Hospital Universitario Virgen Macarena
-
Zamora, Spanien, 49021
- Aktiv, ikke rekrutterende
- Hospital Provincial de Zamora
-
-
-
-
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Incheon, Sydkorea, 21565
- Rekruttering
- Gachon University Gil Medical Center
-
Incheon, Sydkorea, 22332
- Rekruttering
- Inha University Hospital
-
Seoul, Sydkorea, 06351
- Rekruttering
- Samsung Medical Center
-
Seoul, Sydkorea, 02841
- Rekruttering
- Korea University Anam Hospital
-
Seoul, Sydkorea, 07061
- Rekruttering
- SMG-SNU Boramae Medical Center
-
Seoul, Sydkorea, 04763
- Afsluttet
- Hanyang University Seoul Hospital
-
Seoul, Sydkorea, 05030
- Trukket tilbage
- Konkuk University Medical Center
-
Seoul, Sydkorea, 03312
- Afsluttet
- Eunpyeong St. Mary's Hospital
-
-
-
-
-
Kaohsiung City, Taiwan, 80756
- Rekruttering
- Kaohsiung Medical University Chung-Ho Memorial Hospital
-
Kaohsiung City, Taiwan
- Rekruttering
- E-DA Hospital
-
New Taipei City, Taiwan, 23561
- Trukket tilbage
- Taipei Medical University-Shuang Ho Hospital
-
Tainan, Taiwan, 704
- Trukket tilbage
- National Cheng Kung University Hospital
-
Taipei, Taiwan, 10002
- Rekruttering
- National Taiwan University Hospital
-
-
-
-
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Brno, Tjekkiet, 656 91
- Aktiv, ikke rekrutterende
- Fakultni nemocnice u sv. Anny v Brne
-
Choceň, Tjekkiet, 56501
- Aktiv, ikke rekrutterende
- NEUROHK s.r.o
-
Prague, Tjekkiet, 186 00
- Trukket tilbage
- INEP medical s.r.o
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Prague, Tjekkiet, 100 00
- Aktiv, ikke rekrutterende
- CLINTRIAL s.r.o.
-
Prague, Tjekkiet, 160 00
- Trukket tilbage
- FORBELI s.r.o.
-
Rychnov nad Kněžnou, Tjekkiet, 516 01
- Aktiv, ikke rekrutterende
- Vestra Clinics s.r.o.
-
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Czech Republic
-
Kladno, Czech Republic, Tjekkiet, 27201
- Aktiv, ikke rekrutterende
- BRAIN-SOUL THERAPY s.r.o.
-
Prague, Czech Republic, Tjekkiet, 109 00
- Aktiv, ikke rekrutterende
- Ad71 S.R.O.
-
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
55 år til 95 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: ACP-204 30 mg
Administration once daily at approximately the same time of day, with or without food |
ACP-204 is a potent and selective antagonist/inverse agonist of 5-hydroxytryptamine (serotonin) receptor subtype 2A. |
|
Eksperimentel: ACP-204 60 mg
Administration once daily at approximately the same time of day, with or without food |
ACP-204 is a potent and selective antagonist/inverse agonist of 5-hydroxytryptamine (serotonin) receptor subtype 2A. |
|
Placebo komparator: Placebo
Administration once daily at approximately the same time of day, with or without food |
ACP-204 matching placebo |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions subscales (SAPS-H+D) total score change from baseline (Substudies 1, 2A, 2B)
Tidsramme: From baseline to Week 6
|
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. |
From baseline to Week 6
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Clinical Global Impression-Severity in the ADP context (CGI-S-ADP) score
Tidsramme: Baseline to Week 6
|
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. |
Baseline to Week 6
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
14. november 2023
Primær færdiggørelse (Anslået)
1. januar 2028
Studieafslutning (Anslået)
1. februar 2028
Datoer for studieregistrering
Først indsendt
27. november 2023
Først indsendt, der opfyldte QC-kriterier
27. november 2023
Først opslået (Faktiske)
7. december 2023
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
5. november 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. november 2026
Sidst verificeret
1. november 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ACP-204-006
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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