Butler Hospital, Rhode Island Mood & Memory Research Institute join Alzheimer’s drug study

PROVIDENCE — Butler Hospital’s Memory and Aging Program and the Rhode Island Mood & Memory Research Institute are participating in Novartis Pharmaceuticals’ international Alzheimer’s disease prevention study of the efficacy of an oral medication, CNP520, in slowing the buildup of amyloid plaques and delaying cognitive decline in people at risk for the disease.

Amyloid build-up is one of the major causes of Alzheimer’s and can begin as much as two decades before the onset of the clinical symptoms.

The study, called Generation 2, is a clinical trial sponsored by Novartis in collaboration with Banner Alzheimer’s Institute and Amgen. The trial is designed for cognitively healthy adults, aged 60 to 75, who carry at least one copy of the APOE4 gene and have a build-up of cerebral amyloid in the brain, both risk markers for Alzheimer’s.

Butler Hospital in Providence and Rhode Island Mood & Memory Research Institute in East Providence are among 185 research centers across 25 countries participating in Generation 2. There are 22 US research centers participating in the study. Jessica Alber, who holds a doctorate in cognitive neuroscience, is lead investigator at Butler for the study. Dr. John Stoukides, Director of Geriatrics at Roger Williams Medical Center, is lead investigator at RIMMRI.

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The study seeks to enroll 850 people in the United States and 2,000 people world-wide. RIMMRI intends to recruit 10 subjects for the study. Butler intends to recruit 15 people, with eight people from MAP working on the study.

Phase 2 trials, such as Generations 2, are typically $20 million per study, according to Sara Brandon, director of marketing communications at Butler Hospital. Phase 3 studies typically cost about $50 million, she said.

“This exciting trial brings together advances in genetics, brain imaging, and pharmacology to test a medication to prevent or delay memory loss in people at risk of developing Alzheimer’s disease,” said Dr. Stephen Salloway, director of MAP and professor of neurology and psychiatry at the Warren Alpert Medical School.

Alber, also lead investigator for several other studies researching Alzheimer’s detection and prevention, said she is grateful for each person who signs up to participate.

“Those who join an Alzheimer’s prevention research study are truly making a difference for future generations. We are getting close to finding ways to prevent the disease, and this study brings hope for a breakthrough. Today is a very big day for Butler and Brown, and I’m honored to be part of it,” said Alber, also assistant professor of psychiatry and human behavior at Brown.

As a randomized, double blind study, neither the research team nor the participants are aware of whether the drug or a placebo is being administered in the form of a daily pill. Participants will be followed for five to eight years, with regular follow-up evaluations to identify changes in brain amyloid through brain imaging, cognitive function through testing, and tracking of other disease biomarkers.

Rob Borkowski is a PBN staff writer. Email at Borkowski@PBN.com.