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New hope for dementia psychosis: experimental drug ACP-204 enters key trial

NCT ID NCT07029581

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 25, 2026 · Updated 6 times

Summary

This study tests whether the experimental drug ACP-204 can reduce psychosis symptoms like hallucinations and delusions in people with Lewy body dementia. About 180 adults aged 55 to 85 will take either ACP-204 or a placebo daily for 6 weeks. The goal is to see if the drug safely improves symptoms compared to a dummy pill.

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
What this could lead to
If successful, this could point toward a new treatment option for psychosis in people with Lewy body dementia, potentially easing distressing symptoms like hallucinations and delusions.
What could go wrong
This is an early Phase 2 trial with only 180 participants, so results may not apply to everyone. The drug may not work better than placebo, and side effects are still being studied.

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

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 180 people

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

Started

Aug 2025

Expected to finish

Mar 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 84 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: * Male or female ≥55 years to \<85 years of age at the Screening visit living in the community or, if permitted by local regulations, in an institutionalized setting * Can provide written informed consent. If the subject is deemed not competent to provide informed consent, the following requirements for consent must be met: 1. The subject's LAR must provide written informed consent. 2. The subject must provide written (if capable) informed assent per local regulations. * Meets either the clinical criteria for Parkinson's disease with dementia as defined by the Movement Disorder Society's Task Force or the revised clinical criteria for probable dementia with Lewy bodies (DLB) by consensus criteria (Fourth consensus report of the DLB Consortium). * Meets the revised criteria for psychosis in major or mild neurocognitive disorder established by the International Psychogeriatrics Association Exclusion Criteria: * Is in hospice, is receiving end-of-life palliative care, or is bedridden * Has psychotic symptoms that are primarily attributable to delirium, substance abuse, or a medical or psychiatric condition (e.g. schizophrenia, bipolar disorder, delusional disorder) other than dementia * Is actively suicidal at Visit 1 (Screening) or Visit 2 (Baseline) * Has a history or current evidence of a serious and/or significant unstable cardiovascular, respiratory, endocrine, gastrointestinal, renal, hepatic, hematologic, immunologic, genitourinary, psychiatric or neurologic (including stroke, chronic seizures, or clinically significant head injury) abnormality or disease or other medical disorder, including cancer or malignancies that could interfere with subject's ability to complete the study or comply with study procedures * Has other clinically significant CNS abnormalities that are most likely contributing to the dementia or findings on MRI or CT

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Conditions

The condition(s) this trial relates to.

Lewy body dementia

As listed by the trial registrant

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

Lewy body dementia psychosis

How to take part

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

  1. The places running it

    58 sites in 6 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

  • ATP Clinical Research Inc.

    RECRUITING

    Irvine, California, 92612, United States

  • Abington Neurological Associates, LTD

    WITHDRAWN

    Abington, Pennsylvania, 19001, United States

  • Advanced Clinical Research Network, Corp

    RECRUITING

    Miami, Florida, 33135, United States

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

    RECRUITING

    Cherven Bryag, 5980, Bulgaria

  • Azieda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

    RECRUITING

    Brescia, 25123, Italy

  • Azienda Ospedaliera Univerrsitaria

    RECRUITING

    Naples, Napoli, 80138, Italy

  • Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi D'Aragona

    RECRUITING

    Salerno, Salerno, 84131, Italy

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

    RECRUITING

    Roma, 185, Italy

  • CHRU de Nancy- Hospital de Brabois

    RECRUITING

    Vandœuvre-lès-Nancy, 54511, France

  • CHRU de Tours- Hopital Bretonneau

    RECRUITING

    Tours, 37044, France

  • CHU Strasbourg-Hopital Hautepierre

    RECRUITING

    Strasbourg, 67000, France

  • CHU de Toulouse- Hopital Purpan

    RECRUITING

    Toulouse, Cedex 9, 31059, France

  • Cleveland Clinic Foundation

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • DCC "Sv. Vrach and Sv. Sv. Kuzma and Damyan", OOD

    RECRUITING

    Sofia, 1408, Bulgaria

  • DCC Mladost M- Varna, OOD

    RECRUITING

    Varna, 9000, Bulgaria

  • EvergreenHealth

    RECRUITING

    Kirkland, Washington, 98034, United States

  • Fakultni nemocnice u sv. Anny v Brne

    RECRUITING

    Brno, 656 91, Czechia

  • Georgetown University

    RECRUITING

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

  • Gérontopôle Centre de Recherche Clinique

    RECRUITING

    Toulouse, Cedex 9, 31059, France

  • Hawaii Pacific Neuroscience

    RECRUITING

    Honolulu, Hawaii, 96817, United States

  • Health Synergy Clinical Research, LLC

    RECRUITING

    West Palm Beach, Florida, 33407, United States

  • Homestead Associates in Research Inc

    RECRUITING

    Miami, Florida, 33032, United States

  • Hopital BROCA

    WITHDRAWN

    Paris, 75013, France

  • Hopital Neurologique Bron

    RECRUITING

    Bron, 69677, France

  • Hopital Roger Salengro - CHU Lille

    RECRUITING

    Lille, Nord, 59037, France

  • Horizon Clinical Research Group

    RECRUITING

    Cypress, Texas, 77429, United States

  • Humanity Clinical Research, Corp

    RECRUITING

    Aventura, Florida, 33180, United States

  • Hôpital Lariboisière, Histologie et CMRR

    RECRUITING

    Paris, Paris, 75010, France

  • Hôpital des Chapennes

    RECRUITING

    Villeurbanne, Rhone, 69100, France

  • Institute of Mental Health

    RECRUITING

    Belgrade, 11000, Serbia

  • K2 Medical Research Winter Garden LLC

    RECRUITING

    Clermont, Florida, 34711, United States

  • K2 Summit Research

    RECRUITING

    Lady Lake, Florida, 32159, United States

  • MediClear Medical & Research Center, Inc.

    RECRUITING

    Miami, Florida, 33165, United States

  • Medical Center Detsko Zdrave Branch Maestro Kanev

    RECRUITING

    Sofia, 1618, Bulgaria

  • Medical Center SV.Naum

    RECRUITING

    Sofia, 1113, Bulgaria

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

    RECRUITING

    Choceň, 56501, Czechia

  • Neurology Associates, P. A.

    RECRUITING

    Maitland, Florida, 32751, United States

  • Neuropsychiatrie s.r.o.

    RECRUITING

    Prague, 16000, Czechia

  • Parkinson's Disease and Movement Disorders Center of Boca Raton

    RECRUITING

    Boca Raton, Florida, 33486, United States

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

    RECRUITING

    Commack, New York, 11725, United States

  • Premier Clinical Research Institute, Inc.

    RECRUITING

    Miami, Florida, 33122, United States

  • Prolato Clinical Research Center

    RECRUITING

    Houston, Texas, 77054, United States

  • R and H Clinical Research

    RECRUITING

    Stafford, Texas, 77477, United States

  • Rush University Medical Center

    RECRUITING

    Chicago, Illinois, 60612, United States

  • The Movement Disorder Clinic of Oklahoma

    RECRUITING

    Tulsa, Oklahoma, 74136, United States

  • The Ohio State University, Energy Advancement and Innovation Center

    RECRUITING

    Columbus, Ohio, 43210, United States

  • The University of Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

  • The University of Texas Health Science Center San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

  • UMHAT "Alexandrovska" EAD

    RECRUITING

    Sofia, 1431, Bulgaria

  • UMHAT Sv Georgi EAD

    RECRUITING

    Plovdiv, 4002, Bulgaria

  • UNC Hospitals

    RECRUITING

    Chapel Hill, North Carolina, 27517, United States

  • University Clinical Center Kragujevac

    RECRUITING

    Kragujevac, 34000, Serbia

  • University Clinical Center of Serbia

    RECRUITING

    Belgrade, 11000, Serbia

  • University Clinical Hospital Center Zvezdara

    RECRUITING

    Belgrade, 11000, Serbia

  • University of Florida - Shands

    RECRUITING

    Gainesville, Florida, 32608, United States

  • University of Kansas Medical Center Research Institute Inc.

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • Università Campus Bio-Medico di Roma

    RECRUITING

    Roma, 128, Italy

  • Vestra Clinics s.r.o

    RECRUITING

    Rychnov nad Kněžnou, 51601, Czechia

  • Virginia Commonwealth University (a public institution of higher education)

    RECRUITING

    Richmond, Virginia, 23219, United States

  • Vseobecna fakultni nemocnice v Praze

    RECRUITING

    Prague, 12808, Czechia

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