Recruiting NCT07029581
Phase 2, Efficacy and Safety Study of ACP-204 in Lewy Body Dementia Psychosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ACP-204, Placebo.
- Who it may be relevant to
- Registry conditions: Lewy Body Dementia Psychosis. Basic parameters: 55 years — 84 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Bulgaria, Czechia, France, Italy +1
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Double-Blind, Placebo-Controlled, Phase 2, Efficacy and Safety Study of ACP-204 in Adults With Lewy Body Dementia Psychosis (LBDP)
Overview
Multicenter, randomized, 6-week, double-blind, placebo-controlled, parallel-group, Phase 2 study in subjects with LBDP.
Detailed description
Study Website: https://illumerastudy.com/
Interventions
- Drug ACP-204
Provided as 1 capsule, to be taken orally once daily - Drug Placebo
Provided as 1 capsule, to be taken orally once daily
Primary outcome measures
- Change from Baseline in SAPS-LBDP total score at Week 6 [Time frame: 6 weeks]
Eligibility criteria
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:
- 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
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 28 centers
- ATP Clinical Research Inc. — Irvine
- Georgetown University — Washington D.C.
- Humanity Clinical Research, Corp — Aventura
- Parkinson's Disease and Movement Disorders Center of Boca Raton — Boca Raton
- K2 Medical Research Winter Garden LLC — Clermont
- University of Florida - Shands — Gainesville
- K2 Summit Research — Lady Lake
- Neurology Associates, P. A. — Maitland
- … and 20 more centers
France · 10 centers
- CHU de Toulouse- Hopital Purpan — Toulouse
- Gérontopôle Centre de Recherche Clinique — Toulouse
- Hopital Roger Salengro - CHU Lille — Lille
- Hôpital Lariboisière, Histologie et CMRR — Paris
- Hôpital des Chapennes — Villeurbanne
- Hopital Neurologique Bron — Bron
- Hopital BROCA — Paris
- CHU Strasbourg-Hopital Hautepierre — Strasbourg
- … and 2 more centers
Bulgaria · 7 centers
- Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry - Dr Ivo Nat — Cherven Bryag
- UMHAT Sv Georgi EAD — Plovdiv
- Medical Center SV.Naum — Sofia
- DCC "Sv. Vrach and Sv. Sv. Kuzma and Damyan", OOD — Sofia
- UMHAT "Alexandrovska" EAD — Sofia
- Medical Center Detsko Zdrave Branch Maestro Kanev — Sofia
- DCC Mladost M- Varna, OOD — Varna
Czechia · 5 centers
- Fakultni nemocnice u sv. Anny v Brne — Brno
- NEUROHK s.r.o. Poliklinika Chocen a.s. — Choceň
- Vseobecna fakultni nemocnice v Praze — Prague
- Neuropsychiatrie s.r.o. — Prague
- Vestra Clinics s.r.o — Rychnov nad Kněžnou
Italy · 5 centers
- Azienda Ospedaliera Univerrsitaria — Naples
- Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi D'Aragona — Salerno
- Azieda Socio Sanitaria Territoriale degli Spedali Civili di Brescia — Brescia
- Università Campus Bio-Medico di Roma — Roma
- Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza, — Roma
Serbia · 4 centers
- Institute of Mental Health — Belgrade
- University Clinical Center of Serbia — Belgrade
- University Clinical Hospital Center Zvezdara — Belgrade
- University Clinical Center Kragujevac — Kragujevac
Identifiers
NCT: NCT07029581 · ACP-204-012 · 2025-521710-25-00