Lewy Body Dementia PsychosisPhase 3NCT07095465
Phase 3, Open Label Extension Study of ACP-204 in Lewy Body Dementia Psychosis
A Phase 3 study testing ACP-204 in people with Lewy Body Dementia Psychosis, run by ACADIA Pharmaceuticals Inc. at 32 sites in 6 countries.
Trial summary
A 52-Week, Phase 3, Open-Label Extension Study of ACP-204 in Adults With Lewy Body Dementia Psychosis (LBDP) Read more about this study
- Who is it for?
- Ages 55 to 84 years
- Conditions the study is for
- Lewy Body Dementia Psychosis
- What is being tested?
- ACP-204
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 32 sitesin 6 countries
- Study dates
- 14 Nov 2025to Mar 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- The subject's LAR (or study partner/caregiver, if local regulations allow) must provide written informed consent.
- The subject must provide written (if capable) informed assent per local regulations
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- 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:
- Refrain from donating sperm, AND
- 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
Who cannot join
- 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:
- jeopardize the safe participation of the subject in this study; OR
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- 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
Trial locations and contacts
32 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
32 sites in 6 countries
United States18 sites, 18 recruiting
- Recruiting
Humanity Clinical Research, Corp
Aventura, Florida, 33180
- Recruiting
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, 33486
- Recruiting
The Ohio State University, Energy Advancement and Innovation Center
Columbus, Ohio, 43210
- Recruiting
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
- Recruiting
Horizon Clinical Research Group
Cypress, Texas, 77429
- Recruiting
Hawaii Pacific Neuroscience
Honolulu, Hawaii, 96817
- Recruiting
ATP Clinical Research Inc.
Irvine, California, 92612
- Recruiting
University of Kansas Medical Center Research Institute Inc.
Kansas City, Kansas, 66160
- Recruiting
EvergreenHealth
Kirkland, Washington, 98034
- Recruiting
K2 Summit Research
Lady Lake, Florida, 32159
- Recruiting
Homestead Associates in Research Inc
Miami, Florida, 33032
- Recruiting
Advanced Clinical Research Network, Corp
Miami, Florida, 33135
- Recruiting
MediClear Medical & Research Center, Inc.
Miami, Florida, 33165
- Recruiting
Virginia Commonwealth University (a public institution of higher education)
Richmond, Virginia, 23219
- Recruiting
The University of Texas Health Science Center San Antonio
San Antonio, Texas, 78229
- Recruiting
R and H Clinical Research
Stafford, Texas, 77477
- Recruiting
The Movement Disorder Clinic of Oklahoma
Tulsa, Oklahoma, 74136
- Recruiting
Health Synergy Clinical Research, LLC
West Palm Beach, Florida, 33407
Bulgaria4 sites, 4 recruiting
- Recruiting
Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry - Dr Ivo Natsov
Cherven Bryag, 5980
- Recruiting
DCC "Sv. Vrach and Sv. Sv. Kuzma and Damyan", OOD
Sofia, 1408
- Recruiting
UMHAT "Alexandrovska" EAD
Sofia, 1431
- Recruiting
DCC Mladost M- Varna, OOD
Varna, 9000
Czechia3 sites, 3 recruiting
- Recruiting
Fakultni Nemocnice u sv. Anny v Brne
Brno, 656 91
- Recruiting
NEUROHK s.r.o. Poliklinika Chocen a.s.
Choceň, 56501
- Recruiting
Vestra Clinics s.r.o
Rychnov nad Kněžnou, 51601
France3 sites, 3 recruiting
- Recruiting
Hopital Neurologique Bron
Bron, Rhone, 69677
- Recruiting
CHU Strasbourg-Hopital Hautepierre
Strasbourg, 67000
- Recruiting
CHU Tours- Hopital Bretonneau
Tours, Cedex 9, 37044
Italy3 sites, 3 recruiting
- Recruiting
Azienda Ospedaliera Univerrsitaria
Naples, Napoli, 80138
- Recruiting
Università Campus Bio-Medico di Roma
Roma, Roma, 128
- Recruiting
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza, UOI Day Hospital di Neurologia
Roma, Roma, 185
Serbia1 site, 1 recruiting
- Recruiting
Institute of Mental Health
Belgrade, 11000
About this study
Official title: 52-Week, Phase 3, Open-Label Extension Study of ACP-204 in Adults With Lewy Body Dementia Psychosis (LBDP)
A 52-Week, Phase 3, Open-Label Extension Study of ACP-204 in Adults With Lewy Body Dementia Psychosis (LBDP)
Read the detailed description
Study Website: https://illumerastudy.com/
- Conditions
- Lewy Body Dementia Psychosis
- Being tested
- ACP-204
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACP-204Drug
Also called ACP-204 Tartrate
Provided as 1 capsule, to be taken orally once daily
| Study group | Role | What they receive |
|---|---|---|
| ACP-204 | Experimental | Initiation of treatment with ACP-204 at a dose of 30 mg once daily. During the trial, the dose may be adjusted, i.e. uptitration to 60 mg in case of suboptimal efficacy or subsequent down titration to 30 mg. Repeated titration steps are allowed. Receives: Drug: ACP-204 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects who experience treatment-emergent adverse events (TEAEs)
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start14 Nov 2025
- Primary completionFeb 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lewy Body Dementia 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 126 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
- NCT07095465
- Sponsor's protocol ID
- ACP-204-013
- Other IDs
- 2025-521711-39-00, 2025
- Status last verified
- Sep 2026
- First submitted
- 24 Jul 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 52-Week, Phase 3, Open-Label Extension Study of ACP-204 in Adults With Lewy Body Dementia Psychosis (LBDP)
- ClinicalTrials.gov ID
- NCT07095465
- Acronym / sponsor ID
- ACP-204-013
- Conditions
- Lewy Body Dementia Psychosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- ACADIA Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Nov 2025 (actual)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A 52-Week, Phase 3, Open-Label Extension Study of ACP-204 in Adults With Lewy Body Dementia Psychosis (LBDP)
Detailed description
Study Website: https://illumerastudy.com/
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACP-204 | Experimental | Drug: ACP-204Initiation of treatment with ACP-204 at a dose of 30 mg once daily. During the trial, the dose may be adjusted, i.e. uptitration to 60 mg in case of suboptimal efficacy or subsequent down titration to 30 mg. Repeated titration steps are allowed. |
Who may qualify
- Ages
- 55 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- If the subject is a female, she must be of nonchildbearing potential
Key exclusion criteria (10 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACP-204Also: ACP-204 TartrateProvided as 1 capsule, to be taken orally once daily | Drug | ACP-204 |
Primary outcome
Proportion of subjects who experience treatment-emergent adverse events (TEAEs)
Time frame: 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Lewy Body Dementia Psychosis
RecruitingPhase 2
Phase 2, Efficacy and Safety Study of ACP-204 in Lewy Body Dementia Psychosis
Lewy Body Dementia Psychosis
RecruitingPhase 4
Comparing Antipsychotic Medications in LBD Over Time
Parkinson's Disease Psychosis, Dementia With Lewy Bodies
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
32 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ACP-204 in people with Lewy Body Dementia Psychosis, run by ACADIA Pharmaceuticals Inc. at 32 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, Bulgaria, Czechia, France, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristin Kidd (434-841-3162, Kristin.kidd@acadia-pharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects who experience treatment-emergent adverse events (TEAEs) (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.