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New pill aims to quiet hallucinations in Alzheimer's patients

NCT ID NCT06159673

Symptom relief Sponsor: ACADIA Pharmaceuticals Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 01, 2026 · Updated 4 times

Summary

This clinical trial tests a drug called ACP-204 to see if it can reduce hallucinations and delusions in people with Alzheimer's disease. The study will involve over 1,000 adults aged 55 to 95 who have Alzheimer's and psychosis. Participants will receive either ACP-204 or a placebo for 6 weeks, and researchers will track changes in their symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ACP-204 (a drug that blocks serotonin receptors in the brain)
What this could lead to
If successful, this could provide a new treatment option to reduce hallucinations and delusions in people with Alzheimer's disease, improving their quality of life.
What could go wrong
This is an early-to-mid-stage trial, so the drug may not prove effective or safe. Side effects are possible, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 1,074 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2023

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

55 to 95 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Delusions Hallucinations

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alzheimer's disease psychosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    68 sites in 7 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • ABBA Medical Group LLC

    RECRUITING

    Miami, Florida, 33176, United States

  • AOU Policlinico Umberto I

    WITHDRAWN

    Roma, 00185, Italy

  • ASST degli Spedali Civili di Brescia

    ACTIVE_NOT_RECRUITING

    Brescia, 25123, Italy

  • ATP Clinical Research

    RECRUITING

    Costa Mesa, California, 92626, United States

  • Abington Neurological Associates

    RECRUITING

    Abington, Pennsylvania, 19001, United States

  • Ad71 S.R.O.

    ACTIVE_NOT_RECRUITING

    Prague, Czech Republic, 109 00, Czechia

  • Advanced Clinical Research Network, Corp

    RECRUITING

    Miami, Florida, 33135, United States

  • Advanced Research Center, Inc.

    WITHDRAWN

    Anaheim, California, 92805, United States

  • Alivation Research, LLC

    WITHDRAWN

    Lincoln, Nebraska, 68526, United States

  • Arrow Clinical Trials

    RECRUITING

    Daytona Beach, Florida, 32117, United States

  • Azienda Ospedaliera Card. G. Panico

    ACTIVE_NOT_RECRUITING

    Tricase, 73039, Italy

  • Azienda Ospedaliera Universitaria OO. RR. S.

    ACTIVE_NOT_RECRUITING

    Salerno, 84131, Italy

  • B&B Investigaciones Medicas SC

    RECRUITING

    Mazatlán, 82140, Mexico

  • BIND Investigaciones S.C.

    RECRUITING

    San Luis Potosí City, 78213, Mexico

  • BR Trials-Ensaios Clinicos e Consultoria

    RECRUITING

    São Paulo, 01236-030, Brazil

  • BRAIN-SOUL THERAPY s.r.o.

    ACTIVE_NOT_RECRUITING

    Kladno, Czech Republic, 27201, Czechia

  • Biomedica Research Group

    RECRUITING

    Santiago, 7500710, Chile

  • CECPAR Centro de Estudos Clinicos do Parana

    RECRUITING

    Curitiba, 80030-310, Brazil

  • CHRU de Tours- Hopital Bretonneau

    ACTIVE_NOT_RECRUITING

    Tours, 37044, France

  • CHU Rouen-Hospital Charles Nicolle

    ACTIVE_NOT_RECRUITING

    Rouen, 76031, France

  • CHU de Limoges-Hopital Dupuytren

    ACTIVE_NOT_RECRUITING

    Limoges, 87042, France

  • CIC de la Universidad Catolica CICUC

    RECRUITING

    Santiago, 8330024, Chile

  • CLINTRIAL s.r.o.

    ACTIVE_NOT_RECRUITING

    Prague, 100 00, Czechia

  • Central Miami Medical Institute

    WITHDRAWN

    Miami, Florida, 33125, United States

  • Centre Memoire Ressources Recherche CMRR

    ACTIVE_NOT_RECRUITING

    Dijon, 21000, France

  • Centre pour Personnes Âgées

    WITHDRAWN

    Colmar, 68000, France

  • Centro Estudios Clínicos y Esp. Médicas SC CECEM

    RECRUITING

    Nuevo León, 64620, Mexico

  • Centro para el Des de la Med y de Asist Med Esp SC

    RECRUITING

    Sinaloa, 80230, Mexico

  • Chandler Clinical Trials

    RECRUITING

    Chandler, Arizona, 85224, United States

  • Clinica Neurologica e Neurocirurgica de Joinville

    RECRUITING

    Joinville, Santa Catarina, 89202-190, Brazil

  • Clinical Endpoint LLC

    RECRUITING

    Scottsdale, Arizona, 85258, United States

  • Clinical Hosp Center Dr Dragisa Misovic Dedinje

    ACTIVE_NOT_RECRUITING

    Belgrade, 11000, Serbia

  • Clinical Research Institute S.C

    RECRUITING

    Estado de México, 54055, Mexico

  • Clinical Trial Network LLC

    RECRUITING

    Houston, Texas, 77074, United States

  • Clinical. Hospital Center Zvezdara

    ACTIVE_NOT_RECRUITING

    Belgrade, 11000, Serbia

  • Combined Research Orlando Phase I IV

    RECRUITING

    Orlando, Florida, 32807, United States

  • DCC "Higia"

    ACTIVE_NOT_RECRUITING

    Pazardzhik, 4400, Bulgaria

  • DCC St. Vrach and St. St. Kuzma and Damian OOD

    ACTIVE_NOT_RECRUITING

    Sofia, 1408, Bulgaria

  • Dent Neurologic Institute

    WITHDRAWN

    Amherst, New York, 14226, United States

  • Dipartimento di Neuroscienze Rita Levi Montalcini

    WITHDRAWN

    Torino, 10126, Italy

  • E-DA Hospital

    RECRUITING

    Kaohsiung City, Taiwan

  • ET Dr. Ivo Natsov - AIPSMC in Psychiatry

    ACTIVE_NOT_RECRUITING

    Cherven Bryag, 5980, Bulgaria

  • Especialidades Medicas L y S

    RECRUITING

    Santiago, 7560356, Chile

  • Eunpyeong St. Mary's Hospital

    TERMINATED

    Seoul, 03312, South Korea

  • FORBELI s.r.o.

    WITHDRAWN

    Prague, 160 00, Czechia

  • Facili-Centro Integrado de Psiquiatria

    RECRUITING

    São Bernardo do Campo, 09726-150, Brazil

  • Fakultni nemocnice u sv. Anny v Brne

    ACTIVE_NOT_RECRUITING

    Brno, 656 91, Czechia

  • Finger Lakes Clinical Research

    WITHDRAWN

    Rochester, New York, 14618, United States

  • First Excellent Research Group

    RECRUITING

    Doral, Florida, 33178, United States

  • Floridian Neuroscience Institutue

    RECRUITING

    Miami Lakes, Florida, 33016, United States

  • Fondazione Policlinico Uni Campus Bio-Medico di Roma

    ACTIVE_NOT_RECRUITING

    Roma, 00128, Italy

  • Future Care Solution, LLC

    RECRUITING

    Miami, Florida, 33165, United States

  • Gachon University Gil Medical Center

    RECRUITING

    Incheon, 21565, South Korea

  • Gen. Hosp. Dr Radivoj Simonovic

    WITHDRAWN

    Sombor, 25000, Serbia

  • General Hospital Valjevo

    WITHDRAWN

    Valjevo, 14000, Serbia

  • Grace Research, LLC

    RECRUITING

    Shreveport, Louisiana, 71105, United States

  • Hanyang University Seoul Hospital

    TERMINATED

    Seoul, 04763, South Korea

  • Health Pharma Professional Research S.A. de C.V.

    RECRUITING

    Mexico City, 03100, Mexico

  • Homestead Associates in Research Inc.

    RECRUITING

    Miami, Florida, 33032, United States

  • Hopital BROCA

    ACTIVE_NOT_RECRUITING

    Paris, 75013, France

  • Hopital Neurologique Bron

    WITHDRAWN

    Bron, 69677, France

  • Hopital Purpan

    WITHDRAWN

    Toulouse, 31059, France

  • Horizon Clinical Research Group

    RECRUITING

    Cypress, Texas, 77429, United States

  • Hospices Civils de Lyon HCL

    WITHDRAWN

    Lyon, 69002, France

  • Hospital Moinhos de Vento

    RECRUITING

    Porto Alegre, 90035-001, Brazil

  • Hospital Provincial de Zamora

    ACTIVE_NOT_RECRUITING

    Zamora, 49021, Spain

  • Hospital Sao Paulo

    RECRUITING

    São Paulo, 04024-002, Brazil

  • Hospital Universitario Dr. Gonzalo Valdes Valdes

    RECRUITING

    Coahuila, 25000, Mexico

  • Hospital Universitario Dr. Jose Eleuterio Gonzalez

    RECRUITING

    Monterrey, Nuevo León, 64460, Mexico

  • Hospital Universitario Virgen Macarena

    ACTIVE_NOT_RECRUITING

    Seville, 41009, Spain

  • Hospital Universitario de Brasilia

    RECRUITING

    Brasília, 70840-901, Brazil

  • Hospital das Clínicas da Faculdade de Medicina USP

    WITHDRAWN

    São Paulo, 05403-000, Brazil

  • Humanity Clinical Research Corp

    RECRUITING

    Aventura, Florida, 33180, United States

  • Hôpital La Grave

    ACTIVE_NOT_RECRUITING

    Toulouse, 31059, France

  • Hôpital Lariboisière

    ACTIVE_NOT_RECRUITING

    Paris, 75010, France

  • Hôpital de Brabois Adultes

    ACTIVE_NOT_RECRUITING

    Vandœuvre-lès-Nancy, 545000, France

  • INEP medical s.r.o

    WITHDRAWN

    Prague, 186 00, Czechia

  • IRCCS Neuromed Istituto Neurologico Mediterraneo

    WITHDRAWN

    Isernia, 86077, Italy

  • Iecsi S.C.

    RECRUITING

    Monterrey, N.L, 64310, Mexico

  • Inha University Hospital

    RECRUITING

    Incheon, 22332, South Korea

  • Insight Clinical Trials LLC

    WITHDRAWN

    Beachwood, Ohio, 44122, United States

  • Inst. de Neurologia de Curitiba Hospital Ecoville

    RECRUITING

    Curitiba, 81210-310, Brazil

  • Institute of Mental Health

    ACTIVE_NOT_RECRUITING

    Belgrade, 11000, Serbia

  • Instituto Mederi de Pesquisa e Saude

    RECRUITING

    Passo Fundo, 99010-120, Brazil

  • Janjic University Clinical Center Kragujevac

    ACTIVE_NOT_RECRUITING

    Kragujevac, 34000, Serbia

  • Jovanovic University Clinical Centre of Kragujevac

    ACTIVE_NOT_RECRUITING

    Kragujevac, 34000, Serbia

  • Kaleidoscope Clinical Research

    RECRUITING

    Houston, Texas, 77089, United States

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    RECRUITING

    Kaohsiung City, 80756, Taiwan

  • Khan Revive Research Institute

    WITHDRAWN

    Rochester Hills, Michigan, 48307, United States

  • Konkuk University Medical Center

    WITHDRAWN

    Seoul, 05030, South Korea

  • Korea University Anam Hospital

    RECRUITING

    Seoul, 02841, South Korea

  • L2IP - Instituto de Pesquisas Clínicas Ltda

    RECRUITING

    Brasília, 70200-730, Brazil

  • MediClear Medical & Research Center, Inc.

    RECRUITING

    Miami, Florida, 33165, United States

  • Medical Center Hera EOOD

    WITHDRAWN

    Sofia, 1510, Bulgaria

  • Medical Center Intermediea

    WITHDRAWN

    Sofia, 1680, Bulgaria

  • Medical Center Lifemed

    WITHDRAWN

    Kardzhali, 6600, Bulgaria

  • Medical center Medconsult Pleven OOD

    ACTIVE_NOT_RECRUITING

    Pleven, 5800, Bulgaria

  • Medical center Spectar-Plovdic EOOD

    WITHDRAWN

    Plovdiv, 4004, Bulgaria

  • Mental Health Centre - Prof. N Shipkovenski EOOD

    ACTIVE_NOT_RECRUITING

    Sofia, 1377, Bulgaria

  • Mexico Centre for Clinical Research S.A de C.V

    RECRUITING

    Mexico City, 03100, Mexico

  • NEUROHK s.r.o

    ACTIVE_NOT_RECRUITING

    Choceň, 56501, Czechia

  • National Cheng Kung University Hospital

    WITHDRAWN

    Tainan, 704, Taiwan

  • National Institute of Clinical Research

    TERMINATED

    Garden Grove, California, 92844, United States

  • National Taiwan University Hospital

    RECRUITING

    Taipei, 10002, Taiwan

  • Neuro-Pain Medical Center

    RECRUITING

    Fresno, California, 93710, United States

  • Neurociencias Estudios Clinicos

    RECRUITING

    Sinaloa, 80020, Mexico

  • Neurologia-Fondazione Instituto G. Giglio

    ACTIVE_NOT_RECRUITING

    Cefalù, 90015, Italy

  • Neuroscience Research Institute

    RECRUITING

    West Palm Beach, Florida, 33407, United States

  • New Life Medical Research Center Inc.

    RECRUITING

    Hialeah, Florida, 33012, United States

  • New Med Research

    RECRUITING

    Miami Gardens, Florida, 33056, United States

  • Nucleo de Pesquisa Clínica do Rio Grande do Sul

    WITHDRAWN

    Porto Alegre, 90430-001, Brazil

  • Ospedale San Raffaele

    WITHDRAWN

    Milan, 20132, Italy

  • Policlinico Universitario Agostino Gemelli

    ACTIVE_NOT_RECRUITING

    Roma, 00168, Italy

  • Premier Clinical Research Institute, Inc.

    RECRUITING

    Miami, Florida, 33122, United States

  • Prolato Clinical Research Center-Patton

    RECRUITING

    Houston, Texas, 77054, United States

  • Psicomed Estudios Medicos

    RECRUITING

    Antofagasta, 1270244, Chile

  • Psych Me Medical Research Inc

    WITHDRAWN

    Tampa, Florida, 33614, United States

  • Quantum Clinical Trials

    RECRUITING

    Miami Beach, Florida, 33140, United States

  • R & H Clinical Research Inc.

    WITHDRAWN

    Stafford, Texas, 77477, United States

  • Regional Neurological Associates

    WITHDRAWN

    The Bronx, New York, 10466, United States

  • Reliable Clinical Research LLC.

    RECRUITING

    Hialeah, Florida, 33012, United States

  • Revive Research Institute, Inc.

    WITHDRAWN

    Elgin, Illinois, 60123, United States

  • Ruschel Medicina e Pesquisa Clínica

    RECRUITING

    Rio de Janeiro, 22270-060, Brazil

  • SMG-SNU Boramae Medical Center

    RECRUITING

    Seoul, 07061, South Korea

  • SUNY Upstate Medical University

    RECRUITING

    Syracuse, New York, 13210, United States

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

  • Santa Paula Hospital Clinical Research Center

    RECRUITING

    São Paulo, 04550-000, Brazil

  • Special Hospital for Cerebrovascular Disease Sveti Sava

    ACTIVE_NOT_RECRUITING

    Belgrade, 11000, Serbia

  • Special Hospital for Psychiatric Diseases

    ACTIVE_NOT_RECRUITING

    Gornja Toponica, 18202, Serbia

  • Spl. Hosp. for Psychiatric Diseases Kovin

    TERMINATED

    Kovin, 26220, Serbia

  • Spl. Hosp. for Psychiatric Diseases Sveti Vracevi

    WITHDRAWN

    Novi Kneževac, 23330, Serbia

  • Steven South Goldstein MD and Associates

    RECRUITING

    Houston, Texas, 77089, United States

  • Taipei Medical University-Shuang Ho Hospital

    WITHDRAWN

    New Taipei City, 23561, Taiwan

  • Tekton Research, LLC

    RECRUITING

    St Louis, Missouri, 63128, United States

  • Tranquil Clinical Research

    WITHDRAWN

    Webster, Texas, 77598, United States

  • TrialTech Tecnologia com Pesquisas em Medicamentos

    RECRUITING

    Curitiba, 80240-280, Brazil

  • UMHAT "Alexandrovska" EAD

    ACTIVE_NOT_RECRUITING

    Sofia, 1431, Bulgaria

  • UMHAT Alexandrovska EAD

    ACTIVE_NOT_RECRUITING

    Sofia, 1431, Bulgaria

  • UMHAT Prof. Dr. St. Kirkovich AD

    WITHDRAWN

    Stara Zagora, 6003, Bulgaria

  • UMHAT Sv. Georgi EAD

    ACTIVE_NOT_RECRUITING

    Plovdiv, 4000, Bulgaria

  • University Clinic Centre of Serbia

    RECRUITING

    Belgrade, 11000, Serbia

  • University Clinical Center Kragujevac

    ACTIVE_NOT_RECRUITING

    Kragujevac, 34000, Serbia

  • University Clinical Center Nis

    ACTIVE_NOT_RECRUITING

    Niš, 18000, Serbia

  • University of Texas Health Science Center

    TERMINATED

    Houston, Texas, 77054, United States

  • Valley Medical Research

    WITHDRAWN

    Centerville, Ohio, 45459, United States

  • Verus Clinical Research

    RECRUITING

    Miami, Florida, 33135, United States

  • Vestra Clinics s.r.o.

    ACTIVE_NOT_RECRUITING

    Rychnov nad Kněžnou, 516 01, Czechia

  • Visionary Investigators Network

    WITHDRAWN

    Miami, Florida, 33176, United States

  • World Research Link

    RECRUITING

    Pasadena, Texas, 77504, United States

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