The Hawaii Parkinson’s & Movement Center and Hawaii Parkinson’s Research Unit have been awarded Hawaiʻi’s first clinical research study focused on Lewy Body Dementia (LBD). This landmark study investigates ACP-204 (remlifanserin), an investigational medication developed to treat hallucinations and delusions associated with Lewy Body Dementia, a condition with significant unmet medical need .
Understanding Lewy Body Dementia
Lewy Body Dementia affects more than one million people in the United States and is one of the most common forms of dementia. LBD is a progressive neurodegenerative disease, meaning symptoms worsen over time, and it can significantly impact multiple domains of function.
Common features of LBD include:
- Cognitive decline and fluctuations in attention
- Parkinsonian motor symptoms
- Changes in behavior and mood
- Early visual hallucinations, a hallmark feature of the disease
At a pathological level, LBD is characterized by the accumulation of Lewy bodies, microscopic aggregates composed primarily of α-synuclein protein, within the brain .
Addressing an Unmet Need: Psychosis in LBD
Psychosis—including hallucinations and delusions—is common in Lewy Body Dementia and can be particularly distressing for patients and caregivers. Current treatment options are limited, and many antipsychotic medications can worsen motor symptoms or cause significant side effects in LBD patients.
This research study focuses on addressing this unmet need through investigation of a targeted pharmacologic approach.
What Is ACP-204 (Remlifanserin)?
ACP-204, also known as remlifanserin, is an investigational drug being developed by Acadia Pharmaceuticals for the treatment of dementia-related psychosis, including psychosis associated with Alzheimer’s disease and Lewy Body Dementia .
ACP-204 is a follow-up compound to Acadia’s approved medication pimavanserin (Nuplazid) and is designed to improve upon its pharmacologic profile.
Mechanism of Action
ACP-204 functions as a potent and selective inverse agonist of the 5-HT2A serotonin receptor. By targeting this receptor, the drug aims to:
- Reduce hallucinations
- Reduce delusions
- Minimize impact on motor function
Compared to pimavanserin, ACP-204 has demonstrated:
- Greater potency and selectivity
- A shorter half-life
- Potentially reduced risk of QT prolongation, a heart rhythm abnormality associated with some medications .
About the Clinical Study
The study is designed as a multicenter, randomized, double-blind, placebo-controlled trial, reflecting the gold standard for clinical research.
Study Design Highlights
- Participants receive 30 mg or 60 mg of ACP-204, or placebo
- Primary outcome measure:
- Change in hallucinations and delusions using the Scale for the Assessment of Positive Symptoms – Hallucinations and Delusions (SAPS-H+D)
Eligibility Criteria
- Adults 55–85 years of age
- Diagnosis of Lewy Body Dementia
- Presence of psychosis symptoms (hallucinations and/or delusions)
Research Leadership in Hawaiʻi
This important research is led locally by Kore Liow, MD, Principal Investigator, Neurologist, and Neuroscience Chair at Hawaii Pacific Neuroscience, and Clinical Professor of Medicine (Neurology) at the University of Hawaiʻi John A. Burns School of Medicine.
“Our team of neurologists, neuroscience specialists, and researchers in Hawaii cannot be more proud to be part of this groundbreaking research to develop treatments for Lewy Body Dementia.” — Kore Liow, MD
Learn More or Inquire About Participation
For additional information about this Lewy Body Dementia research study, individuals may:
- Review details through NIH clinical trial resources
- Contact the Hawaii Parkinson’s Disease Center & Hawaii Parkinson’s Research Unit
