Lewy Body Dementia PsychosisPhase 2NCT07029581
Phase 2, Efficacy and Safety Study of ACP-204 in Lewy Body Dementia Psychosis
A Phase 2 study testing ACP-204 in people with Lewy Body Dementia Psychosis, run by ACADIA Pharmaceuticals Inc. at 61 sites in 6 countries.
Trial summary
Multicenter, randomized, 6-week, double-blind, placebo-controlled, parallel-group, Phase 2 study in subjects with 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?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 61 sitesin 6 countries
- Study dates
- 6 Aug 2025to Mar 2028
- Phase
- Phase 2
- 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
- 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:
- The subject's LAR must provide written informed consent.
- 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
Who cannot join
- 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
Trial locations and contacts
61 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
61 sites in 6 countries
United States30 sites, 28 recruiting
- Withdrawn
Abington Neurological Associates, LTD
Abington, Pennsylvania, 19001
- Recruiting
The University of Colorado
Aurora, Colorado, 80045
- Recruiting
Humanity Clinical Research, Corp
Aventura, Florida, 33180
- Recruiting
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, 33486
- Recruiting
UNC Hospitals
Chapel Hill, North Carolina, 27517
- Recruiting
Rush University Medical Center
Chicago, Illinois, 60612
- Recruiting
K2 Medical Research Winter Garden LLC
Clermont, Florida, 34711
- Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
- 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
University of Florida - Shands
Gainesville, Florida, 32608
- Recruiting
Hawaii Pacific Neuroscience
Honolulu, Hawaii, 96817
- Recruiting
Prolato Clinical Research Center
Houston, Texas, 77054
- 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
- Terminated
Neurology Associates, P. A.
Maitland, Florida, 32751
- Recruiting
Homestead Associates in Research Inc
Miami, Florida, 33032
- Recruiting
Premier Clinical Research Institute, Inc.
Miami, Florida, 33122
- Recruiting
Advanced Clinical Research Network, Corp
Miami, Florida, 33135
- Recruiting
Verus Clinical Research
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
Georgetown University
Washington D.C., District of Columbia, 20057
- Recruiting
Health Synergy Clinical Research, LLC
West Palm Beach, Florida, 33407
France10 sites, 9 recruiting
- Recruiting
Hopital Neurologique Bron
Bron, 69677
- Recruiting
Hopital Roger Salengro - CHU Lille
Lille, Nord, 59037
- Recruiting
Hôpital Lariboisière, Histologie et CMRR
Paris, Paris, 75010
- Withdrawn
Hopital BROCA
Paris, 75013
- Recruiting
CHU Strasbourg-Hopital Hautepierre
Strasbourg, 67000
- Recruiting
CHU de Toulouse- Hopital Purpan
Toulouse, Cedex 9, 31059
- Recruiting
Gérontopôle Centre de Recherche Clinique
Toulouse, Cedex 9, 31059
- Recruiting
CHRU de Tours- Hopital Bretonneau
Tours, 37044
- Recruiting
CHRU de Nancy- Hospital de Brabois
Vandœuvre-lès-Nancy, 54511
- Recruiting
Hôpital des Chapennes
Villeurbanne, Rhone, 69100
Bulgaria7 sites, 6 recruiting
- Recruiting
Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry - Dr Ivo Natsov
Cherven Bryag, 5980
- Recruiting
UMHAT Sv Georgi EAD
Plovdiv, 4002
- Recruiting
Medical Center SV.Naum
Sofia, 1113
- Recruiting
DCC "Sv. Vrach and Sv. Sv. Kuzma and Damyan", OOD
Sofia, 1408
- Recruiting
UMHAT "Alexandrovska" EAD
Sofia, 1431
- Withdrawn
Medical Center Detsko Zdrave Branch Maestro Kanev
Sofia, 1618
- Recruiting
DCC Mladost M- Varna, OOD
Varna, 9000
Czechia5 sites, 5 recruiting
- Recruiting
Fakultni nemocnice u sv. Anny v Brne
Brno, 656 91
- Recruiting
NEUROHK s.r.o. Poliklinika Chocen a.s.
Choceň, 56501
- Recruiting
Vseobecna fakultni nemocnice v Praze
Prague, 12808
- Recruiting
Neuropsychiatrie s.r.o.
Prague, 16000
- Recruiting
Vestra Clinics s.r.o
Rychnov nad Kněžnou, 51601
Italy5 sites, 5 recruiting
- Recruiting
Azieda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Brescia, 25123
- Recruiting
Azienda Ospedaliera Univerrsitaria
Naples, Napoli, 80138
- Recruiting
Università Campus Bio-Medico di Roma
Roma, 128
- Recruiting
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza, UOI Day Hospital di Neurologia
Roma, 185
- Recruiting
Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi D'Aragona
Salerno, Salerno, 84131
Serbia4 sites, 4 recruiting
- Recruiting
Institute of Mental Health
Belgrade, 11000
- Recruiting
University Clinical Center of Serbia
Belgrade, 11000
- Recruiting
University Clinical Hospital Center Zvezdara
Belgrade, 11000
- Recruiting
University Clinical Center Kragujevac
Kragujevac, 34000
About this study
Official title: A Double-Blind, Placebo-Controlled, Phase 2, Efficacy and Safety Study of ACP-204 in Adults With Lewy Body Dementia Psychosis (LBDP)
Multicenter, randomized, 6-week, double-blind, placebo-controlled, parallel-group, Phase 2 study in subjects with LBDP.
Read the detailed description
Study Website: https://illumerastudy.com/
- Conditions
- Lewy Body Dementia Psychosis
- Being tested
- ACP-204, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACP-204Drug
Provided as 1 capsule, to be taken orally once daily
PlaceboDrug
Provided as 1 capsule, to be taken orally once daily
| Study group | Role | What they receive |
|---|---|---|
| ACP-204 30 mg | Experimental | ACP-204 dose of 30 mg once daily Receives: Drug: ACP-204 |
| ACP-204 60 mg | Experimental | ACP-204 dose of 60 mg once daily Receives: Drug: ACP-204 |
| Placebo | Placebo comparator | Placebo once daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in SAPS-LBDP total score at Week 6
Change from Baseline in Scale for the Assessment of Positive Symptoms- Lewy Body Dementia Psychosis (SAPS-LBDP) total score at Week 6
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start6 Aug 2025
- Primary completionFeb 2028 (estimated)
- Study completionMar 2028 (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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized to one of 3 parallel arms i.e. ACP-204 at one of 2 dose levels (30 or 60 mg) or placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 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
- NCT07029581
- Sponsor's protocol ID
- ACP-204-012
- Other IDs
- 2025-521710-25-00, 2025
- Status last verified
- Sep 2025
- First submitted
- 12 Jun 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
- A Double-Blind, Placebo-Controlled, Phase 2, Efficacy and Safety Study of ACP-204 in Adults With Lewy Body Dementia Psychosis (LBDP)
- ClinicalTrials.gov ID
- NCT07029581
- Acronym / sponsor ID
- ACP-204-012
- Conditions
- Lewy Body Dementia Psychosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- ACADIA Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Aug 2025 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 19 Jun 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.
Multicenter, randomized, 6-week, double-blind, placebo-controlled, parallel-group, Phase 2 study in subjects with LBDP.
Detailed description
Study Website: https://illumerastudy.com/
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Subjects will be randomized to one of 3 parallel arms i.e. ACP-204 at one of 2 dose levels (30 or 60 mg) or placebo
| Arm | Type | Receives |
|---|---|---|
| ACP-204 30 mg | Experimental | Drug: ACP-204ACP-204 dose of 30 mg once daily |
| ACP-204 60 mg | Experimental | Drug: ACP-204ACP-204 dose of 60 mg once daily |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo once daily |
Who may qualify
- Ages
- 55 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
- 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
Key exclusion criteria (5 listed)
- 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
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-204Provided as 1 capsule, to be taken orally once daily | Drug | ACP-204 30 mg, ACP-204 60 mg |
| PlaceboProvided as 1 capsule, to be taken orally once daily | Drug | Placebo |
Primary outcome
Change from Baseline in SAPS-LBDP total score at Week 6
Time frame: 6 weeks
Change from Baseline in Scale for the Assessment of Positive Symptoms- Lewy Body Dementia Psychosis (SAPS-LBDP) total score at Week 6
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
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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.
61 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ACP-204 in people with Lewy Body Dementia Psychosis, run by ACADIA Pharmaceuticals Inc. at 61 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 6 inclusion and 5 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 61 sites in United States, France, Bulgaria, Czechia, 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change from Baseline in SAPS-LBDP total score at Week 6 (time frame: 6 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.