UH Med Now
UH Medical School: Phase 1b study announced of NP001 in patients with mild-to-moderate Alzheimer’s Disease
Date: September 13th, 2017 in Research
Pictured: The University of Hawaiʻi Clinics at Kakaʻako
SAN BRUNO, Calif. and HONOLULU, Sept. 13, 2017 — A clinical trial will begin soon on a drug that researchers hope will reduce inflammation in patients with Alzheimer’s Disease.
The University of Hawai’i (UH) John A. Burns School of Medicine (JABSOM) will recruit 14 people, seven of whom will be randomly assigned to obtain the medicine, and seven who will be given a placebo, in what is referred to as a “Phase 1b” clinical trial. The trial involves an investigational therapy, NP001, developed by Neuraltus Pharmaceuticals, Inc., a privately held biopharmaceutical company dedicated to developing innovative therapeutics for neurodegenerative diseases. This study (NCT03179501) aims to whether a single dose of NP001 will affect blood markers that indicate inflammation in individuals with mild-to-moderate Alzheimer’s disease.
The patients selected for the study will receive NP001 or the placebo intravenously at the UH Clinics at Kakaʻako on the JABSOM campus. Researchers and nurses from the R-MATRIX (Multidisciplinary And Translational Research Infrastructure Expansion) Program will oversee the trial.
“This trial wouldn’t be happening in Hawaiʻi without the RMATRIX (Multidisciplinary And Translational Research Infrastructure Expansion) Program at JABSOM, which supports the mentoring of junior scientists and the professional relationships forged through scientific collaboration,” said Dr. Cecilia Shikuma, Professor of Medicine, who oversees operations at the UH Clinics at Kakaʻako.
“Although Alzheimer’s disease is the most common cause of dementia, there is presently no cure for the more than five million Americans living with the disease,” said Beau Nakamoto, MD, PhD, MBA Associate Professor, Department of Medicine, UHM-JABSOM, and principal investigator. “Given the key role inflammatory monocytes and macrophages may play in the progression of Alzheimer’s disease, researching immune regulators – like NP001 – is critical to understanding more about this serious and complex disease.”
Alzheimer’s disease, an irreversible, progressive brain disorder that slowly destroys memory and thinking skills, is currently ranked as the sixth leading cause of death in the United States. While the cause of the disease is unknown, there is increasing evidence that suggests neuroinflammation may play a role in disease progression. NP001, Neuraltus Pharmaceuticals’ lead investigative therapy, is designed to help regulate neuroinflammation.
“We anticipate the Phase 1b study being conducted by the University of Hawaiʻi medical school will help further validate the importance of biomarker research in neurodegenerative conditions, such as Alzheimer’s disease,” said Rich Casey, chief executive officer, Neuraltus Pharmaceuticals. “NP001 has shown promising results in reducing systemic inflammation levels in patients with other neurodegenerative diseases, and we hope that this study will show that it works similarly in Alzheimer’s disease.”