ACTON, Mass. -- Cognoptix announced today that it has reached the halfway point in a multi-site clinical trial of its SAPPHIRE II eye test designed to identify Alzheimer’s disease patients via a beta amyloid (“Ab”) signature in their eyes. By detecting a specific fluorescent signature of ligand-marked beta-amyloid in the supranucleus region of the human lens, SAPPHIRE II achieved a two-fold differentiation factor between a group of five healthy volunteers and a group of five patients diagnosed with probable Alzheimer’s disease in a recent proof-of-concept clinical trial.
The clinical investigators and four clinical trial sites, where enrollment is still underway, include: Bennington, Vt. (Memory Clinic, Cynthia Murphy, PsyD); Miami (Miami Jewish Health Systems, Marc E. Agronin, M.D.); Phoenix (Banner Alzheimer’s Institute, Pierre N. Tariot, M.D.); and West Palm Beach, Fla. (Premiere Research Institute, Carl H. Sadowsky, M.D.).
“We are pleased to be participating in this important study, because there is a critical need for a fast, prophetic, dependable, low-cost and readily available test for the early diagnosis and management of Alzheimer’s disease,” said Pierre N. Tariot, M.D., Director of the Banner Alzheimer’s Institute in Phoenix.
“There is no early-stage, non-invasive diagnostic test for Alzheimer’s disease in the market,” added Paul Hartung, President and CEO of Cognoptix. “This is unacceptable, of course, especially since patients incur significant neuronal loss before they start to exhibit severe enough symptoms to meet the current clinical standards for diagnosis of Alzheimer’s Disease—a process of elimination of other possible disorders such as stroke, trauma, Parkinson’s disease and dementia, achieved only via extensive and expensive cognitive and physical testing.
“On the other hand,” added Hartung, “there are nearly 100 new therapeutic drugs to slow or stop the progress of AD in development and better treatments are expected to reach the market soon. Cognoptix is developing a simple system of early-stage diagnosis to allow treatment before significant neuronal loss and irreversible brain damage happens.”
Cognoptix, a privately held medical technology company headquartered in Acton, Mass., is focused on developing and commercializing an in-office, drug/device diagnostic system as an aid in the early detection of Alzheimer’s Disease (AD). Its investors include Inventages Venture Capital, one of the world’s largest life sciences-, nutrition- and wellness-focused venture capital firms; and Launchpad Venture Group, a Boston-based angel investment firm that provides funding to early-stage companies.
NOTE: The SAPPHIRE II system is approved for investigational use only in the United States.