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NCT07029581 | RECRUITING | Lewy Body Dementia Psychosis


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

ACADIA Pharmaceuticals Inc.

Brief Summary:

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

Condition or disease

Lewy Body Dementia Psychosis

Intervention/treatment

ACP-204

Placebo

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 180 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : A Double-Blind, Placebo-Controlled, Phase 2, Efficacy and Safety Study of ACP-204 in Adults With Lewy Body Dementia Psychosis (LBDP)
Actual Study Start Date : 2025-08
Estimated Primary Completion Date : 2028-02
Estimated Study Completion Date : 2028-03

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 55 Years to 84 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
    • 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
    • * 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

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

Location Details

NCT07029581


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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


RECRUITING

United States, California

ATP Clinical Research Inc.

Irvine, California, United States, 92612

RECRUITING

United States, Florida

Homestead Associates in Research Inc

Miami, Florida, United States, 33032

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