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Hope for lewy body dementia psychosis: new drug enters final testing phase

NCT ID NCT07095465

Disease control 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 trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 24, 2026 · Updated 2 times

Summary

This study tests a drug called ACP-204 for treating psychosis (hallucinations or delusions) in people with Lewy body dementia. It is a 52-week open-label extension, meaning all 126 participants will receive the drug. The main goal is to check for side effects over the long term. Participants must have completed a prior study of the same drug.

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 taken orally once daily)
What this could lead to
If successful, this could provide a long-term treatment option for psychosis in people with Lewy body dementia, helping manage symptoms.
What could go wrong
This is an extension study, not a new trial, and focuses on safety. It is still early to know if the drug works well long-term, and side effects are possible.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 126 people

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

Started

Nov 2025

Expected to finish

Mar 2029

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: * The subject may benefit from long-term therapy with open-label ACP-204 treatment in the judgment of the Investigator * Subject has completed Visit 6 (EOT) of the antecedent ACP-204-012 study and did not have an early discontinuation from the antecedent study * Can complete all study visits with a study partner/caregiver * Can understand the nature of the study and protocol requirements and 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 (or study partner/caregiver, if local regulations allow) must provide written informed consent. 2. The subject must provide written (if capable) informed assent per local regulations * If the subject is a female, she must be of nonchildbearing potential * If the subject is male, he must agree to the following during the study intervention period and for at least 90 days after the last dose of study drug: 1. Refrain from donating sperm, AND 2. Either * Be abstinent from sexual intercourse where pregnancy can occur (abstinent on a long-term and persistent basis) and agree to remain abstinent OR * Use a condom and subject's female partner (if of childbearing potential and not pregnant) must use an additional contraceptive method Exclusion Criteria: * Is judged by the Investigator or the Medical Monitor to be inappropriate for the study for any reason * Is in hospice, is receiving end-of-life palliative care, or is bedridden * Has a heart rate \<50 beats per minute, as measured by vital signs at Baseline (EOT visit of the antecedent study). If bradycardia is secondary to iatrogenic or treatable causes and these causes are addressed, a heart rate assessment can be repeated. * Has a BMI \<18.5 kg/m2 or known unintentional weight loss ≥7% of body weight over past 6 months * Has a clinically significant laboratory abnormality in the antecedent ACP-204-012 study, excepting at ACP-204-012 EOT, that in the judgment of the Investigator or Medical Monitor, will either: 1. jeopardize the safe participation of the subject in this study; OR 2. interfere with the conduct or interpretation of safety or efficacy evaluations in the study * Is actively suicidal at Visit 1 (Baseline, EOT visit of the antecedent study) * Has a neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical or mental disorder, including cancer or malignancies that, in the judgment of the Investigator, would increase the risk associated with taking study medication or significantly interfere with the conduct or interpretation of the study * Requires treatment with a medication or other substance that is prohibited by the protocol or will be used in a way that violates a use restriction

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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

    30 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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.

    Irvine, California, 92612, United States

  • Advanced Clinical Research Network, Corp

    Miami, Florida, 33135, United States

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

    Cherven Bryag, 5980, Bulgaria

  • Azienda Ospedaliera Univerrsitaria

    Naples, Napoli, 80138, Italy

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

    Roma, Roma, 185, Italy

  • CHU Strasbourg-Hopital Hautepierre

    Strasbourg, 67000, France

  • CHU Tours- Hopital Bretonneau

    Tours, Cedex 9, 37044, France

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

    Sofia, 1408, Bulgaria

  • DCC Mladost M- Varna, OOD

    Varna, 9000, Bulgaria

  • EvergreenHealth

    Kirkland, Washington, 98034, United States

  • Fakultni Nemocnice u sv. Anny v Brne

    Brno, 656 91, Czechia

  • Hawaii Pacific Neuroscience

    Honolulu, Hawaii, 96817, United States

  • Health Synergy Clinical Research, LLC

    West Palm Beach, Florida, 33407, United States

  • Homestead Associates in Research Inc

    Miami, Florida, 33032, United States

  • Hopital Neurologique Bron

    Bron, Rhone, 69677, France

  • Horizon Clinical Research Group

    Cypress, Texas, 77429, United States

  • Humanity Clinical Research, Corp

    Aventura, Florida, 33180, United States

  • Institute of Mental Health

    Belgrade, 11000, Serbia

  • K2 Summit Research

    Lady Lake, Florida, 32159, United States

  • MediClear Medical & Research Center, Inc.

    Miami, Florida, 33165, United States

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

    Choceň, 56501, Czechia

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

    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

    Commack, New York, 11725, United States

  • R and H Clinical Research

    Stafford, Texas, 77477, United States

  • The Movement Disorder Clinic of Oklahoma

    Tulsa, Oklahoma, 74136, United States

  • The Ohio State University, Energy Advancement and Innovation Center

    Columbus, Ohio, 43210, United States

  • University of Kansas Medical Center Research Institute Inc.

    Kansas City, Kansas, 66160, United States

  • Università Campus Bio-Medico di Roma

    Roma, Roma, 128, Italy

  • Vestra Clinics s.r.o

    Rychnov nad Kněžnou, 51601, Czechia

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

    Richmond, Virginia, 23219, United States

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