ClinicalTrials.gg
RecruitingNCT07029581Updated Nov 4, 2026

Phase 2, Efficacy and Safety Study of ACP-204 in Lewy Body Dementia Psychosis

A Phase 2 interventional study of ACP-204 and Placebo in Lewy Body Dementia Psychosis, sponsored by ACADIA Pharmaceuticals Inc.. Recruiting at 62 sites in 6 countries. Open to participants aged 55 Years to 84 Years. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by ACADIA Pharmaceuticals Inc. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2025; still recruiting 1 year 3 months later.
Updated Nov 4, 2026Site recruiting status changed2 sites addedGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
55 Years to 84 Years
Sex
All
01

Study summary

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/

02

Conditions studied

  • Lewy Body Dementia Psychosis

Browse trials for

03

In context

Lewy Body Disease

239 studies on the registry are indexed under Lewy Body Disease; 89 are open to participants now.

This study's planned enrollment of 180 is above the median of 89 across 152 interventional studies indexed under Lewy Body Disease.

Browse Lewy Body Disease studies →

Lead sponsor

ACADIA Pharmaceuticals Inc. is the lead sponsor of 41 studies on the registry; 5 are open to participants now.

Of its 26 completed or terminated interventional studies of FDA-regulated products, 24 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 84 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 . 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

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 head injury) abnormality or disease or other medical disorder, including cancer or 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
180 participants (estimated)

Study arms

  • Experimental
    ACP-204 30 mg

    ACP-204 dose of 30 mg once daily

    Drug: ACP-204

  • Experimental
    ACP-204 60 mg

    ACP-204 dose of 60 mg once daily

    Drug: ACP-204

  • Placebo comparator
    Placebo

    Placebo once daily

    Drug: Placebo

Interventions

  • Provided as 1 capsule, to be taken orally once daily

  • DrugPlacebo

    Provided as 1 capsule, to be taken orally once daily

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 6 weeks

07

Study locations

58 of 62 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2025 (actual). Primary completion is estimated for Feb 2028, 30 months after the start.

Of 24 phase 2 interventional studies under Lewy Body Disease, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 45. This study's planned 30 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 12, 2025
First posted
Jun 19, 2025
StartActual
Aug 6, 2025
Primary completionEst.
Feb 2028
CompletionEst.
Mar 2028
Last update
Nov 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
2 sites added. 2 sites changed recruiting status (1 now terminated, 1 now withdrawn)
Show 2 sites
  • Neurology Associates, P. A. · Maitland, United StatesRecruiting→Terminated
  • Medical Center Detsko Zdrave Branch Maestro Kanev · Sofia, BulgariaRecruiting→Withdrawn
Show 2 added (2 United States)
  • Verus Clinical Research · Miami, United States
  • Reliable Clinical Research LLV · Hialeah, United States
across 2 updates, Sep 29, 2026 – Nov 4, 2026
Show all 2 updates
  1. Nov 4, 2026
    1 site added
    Show site
    • Reliable Clinical Research LLV · Hialeah, United States
    + 1 other change: verification date
  2. Sep 29, 2026
    1 site added. 2 sites changed recruiting status (1 now terminated, 1 now withdrawn)
    Show 2 sites
    • Neurology Associates, P. A. · Maitland, United StatesRecruiting→Terminated
    • Medical Center Detsko Zdrave Branch Maestro Kanev · Sofia, BulgariaRecruiting→Withdrawn
    Show site
    • Verus Clinical Research · Miami, United States

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07029581
Responsible party
Sponsor
First posted
Jun 19, 2025
Start date
Aug 6, 2025
Primary completion
Feb 2028 (estimated)
Completion
Mar 2028 (estimated)
Last update
Nov 4, 2026

Study contacts

Kristin Kidd
Contact
Kristin.kidd@acadia-pharm.com
434-841-3162
Becky Howell
Contact
bhowell@acadia-pharm.com
848-702-1886

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Remlifanserin

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