Enrolling by invitation NCT07095465

Phase 3, Open Label Extension Study of ACP-204 in Lewy Body Dementia Psychosis

Phase III Interventional 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.
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 →

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)

Detailed description

Study Website: https://illumerastudy.com/

Proportion of subjects who experience treatment-emergent adverse events (TEAEs) [Time frame: 52 weeks]

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
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:

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

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
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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

United States · 17 centers

Bulgaria · 3 centers

Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry - Dr Ivo Nat — Cherven Bryag
DCC "Sv. Vrach and Sv. Sv. Kuzma and Damyan", OOD — Sofia
DCC Mladost M- Varna, OOD — Varna

Czechia · 3 centers

France · 3 centers

Italy · 3 centers

Azienda Ospedaliera Univerrsitaria — Naples
Università Campus Bio-Medico di Roma — Roma
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza, — Roma

Serbia · 1 center

NCT: NCT07095465 · ACP-204-013 · 2025-521711-39-00