Drexel University researchers have begun a landmark study to determine if a new drug can postpone or even prevent Alzheimer's disease.
The study examines healthy people whose brain scans show the build up of a protein associated with the disease — but who do not yet have any memory loss or other symptoms. The researchers will determine if an investigational treatment can clear the built-up plaque of the protein, called amyloid, before the disease progresses and brain cells are impaired.
"This is truly an exciting and hopeful study. To find a way to prevent or delay Alzheimer's disease would have profound implications for patients and their families as well as for our nation," said Erol Veznedaroglu, MD, director of the Drexel Neurosciences Institute (DNI) and chairman of the Department of Neurosurgery at Drexel University College of Medicine.
Veznedaroglu said federal statistics show that five million Americans currently have Alzheimer's disease and the numbers are expected to triple by 2050.
The principal investigator is Carol F. Lippa, MD, College of Medicine professor and director of the Cognitive Neurology and Alzheimer's program. She said there is limited potential to reverse Alzheimer's once the disease is established and brain cells and neurons are destroyed.
"We believe the key – the real hope – is to clear amyloid plaques before they contribute to the destruction of brain cells in the thinking areas of the brain," Lippa said. "Clearing out the amyloid is like clearing out the kindling before the fire starts. We are hopeful we can prevent Alzheimer's and the enormous suffering that surrounds this disease."
Sticky amyloid can form clumps, or plaque, that may block cell-to-cell signaling among neurons. Scans show this amyloid in the brain for years, even decades, before people experience any cognitive decline. Researchers believe the best hope is to stop the progression of amyloid plaques before symptoms of Alzheimer's begin.
The study is called A4, or Anti-Amyloid in Asymptomatic Alzheimer's Disease Study, and looks at the investigational drug, solanezumab, to reduce plaque formation. The A4 Study is an international, public-private partnership, funded by the National Institutes of Health, Eli Lilly and Company, and several philanthropic organizations. Drexel Neurosciences Institute is one of 60 study sites around the world.
This month, the science series NOVA, which airs on PBS, featured the A4 study during the primetime special, “Can Alzheimer’s Be Stopped?”
Drexel investigators are currently seeking patients who want to contribute to the science for altruistic reasons as well as those who may be concerned about developing Alzheimer's because someone in their family has the mind-robbing disease. Lippa also said they are seeking a diversity of participants and are eager for people from the African American community as well as those from ethnic minority communities to consider joining the study.
"We see Alzheimer's disease in all races and ethnicities," Lippa said.
Participates must be 65 to 85 years old, have normal thinking and memory abilities and be willing to undergo a PET scan of their brain. Those with no sign of amyloids will be part of a separate study. Those with the amyloids will receive IV infusions of the investigational treatment or a placebo every four weeks for three years and also undergo additional memory and medical tests. Lippa said participants would receive free tests to closely follow their medical health.
"Participants in this study will advance our understanding of Alzheimer's and contribute to the search for a way to prevent the disease," Veznedaroglu said.