SOUTH KINGSTOWN — George & Anne Ryan Institute for Neuroscience researchers will investigate reduction of brain blood vessel inflammation in fighting Alzheimer’s disease as part of the $1.3 million, University of Rhode Island-sponsored, BEACON study, the first such clinical trial led and conducted entirely within the state.
The Phase 1 clinical trial, mainly funded by the Alzheimer’s Drug Discovery Foundation, with some private donations, will focus on people with mild cognitive impairment probably due to Alzheimer’s disease and those diagnosed with mild Alzheimer’s disease. Alzheimer’s research clinics at Rhode Island Hospital, Rhode Island Mood and Memory Research Institute, and Butler Hospital will be enrolling participants later this year for the uniquely Rhode Island study. The study will begin enrolling participants this spring.
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“Keeping this study in Rhode Island was important to us,” said Paula Grammas, executive director of the Ryan Institute. “This state has a world-class and closely-linked community of researchers and clinicians, which enables us to pull together resources and make progress quickly.”
The research was also made possible by an independent grant from Boehringer Ingelheim Pharmaceuticals Inc., in the form of providing the active drug for this study, dabigatran. URI’s Pharmaceutical Development Institute, a state-of-the-art training, development and manufacturing facility for production of solid oral dosage forms, is manufacturing the placebo comparator for this trial.
Grammas is among researchers pursuing new approaches to treating Alzheimer’s disease. The new studies follow decades of clinical trials investigating amyloid-beta, a protein accumulating in the brains of Alzheimer’s patients, to little success, according to the Ryan Institute. That research has produced no treatments that slow or stop Alzheimer’s disease, and only a few have been approved to treat its symptoms.
Grammas’s research has shown that factors such as high blood pressure, diabetes, and stroke can injure blood vessels in the brain, resulting in inflammation that could cause the damage or death of brain cells that occurs in Alzheimer’s disease, according to the institute.
The BEACON Study repurposes an existing drug, dabigatran, FDA-approved to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, and for the treatment and to reduce the risk of reoccurrence of deep venous thrombosis and pulmonary embolism, to suppress one part of the inflammation process associated with Alzheimer’s disease. Results from the BEACON Study are expected in late 2020.
“If the drug shows some effects on the progression of Alzheimer’s disease, it would be the first time we’ve found evidence of a treatment that could slow the disease,” says Grammas. “But even if the study’s results are less conclusive, this is a vitally important step forward in expanding our knowledge of the multiple factors that cause this complex disease. I’m very excited to see what happens.”
“The role of the vasculature in Alzheimer’s disease has been grossly under-recognized until relatively recently,” said Dr. Howard Fillit, founding executive director and chief science officer of the Alzheimer’s Drug Discovery Foundation. “As a result, strategies to develop therapeutics to address this important part of the disease have been lacking. We are pleased to work with Dr. Grammas and fund her work using a very novel approach to repurpose an existing drug to treat the vascular abnormalities in Alzheimer’s disease.”
Rob Borkowski is a PBN staff writer. Email him at Borkowski@PBN.com.
