RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Multicenter, randomized, 6-week, double-blind, placebo-controlled, parallel-group, Phase 2 study in subjects with LBDP.

Official Title

A Double-Blind, Placebo-Controlled, Phase 2, Efficacy and Safety Study of ACP-204 in Adults With Lewy Body Dementia Psychosis (LBDP)

Quick Facts

Study Start:2025-08

Study Completion:2028-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07029581

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:55 Years to 84 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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: 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	* 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

Inclusion Criteria

Exclusion 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:
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

* 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

Contacts and Locations

Study Contact

Imran Ghiasudddin

CONTACT

1-847-293

imran.ghiasuddin@acadia-pharm.com

Becky Howell

CONTACT

1-848-702

bhowell@acadia-pharm.com

Study Locations (Sites)

ATP Clinical Research Inc.

Irvine, California, 92612

United States

Homestead Associates in Research Inc

Miami, Florida, 33032

United States

Collaborators and Investigators

Sponsor: ACADIA Pharmaceuticals Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08

Study Completion Date2028-03

Study Record Updates

Study Start Date2025-08

Study Completion Date2028-03

Terms related to this study

Additional Relevant MeSH Terms

Lewy Body Dementia Psychosis