Urinary Assay for Alzheimer's Disease Verified by Clinical Studies

By Labmedica staff writers
Posted on 14 Jan 2008
A urinary assay adds significant useful information in the diagnosis of Alzheimer's disease (AD), particularly for the family physician.

AlzheimAlert is a non-invasive accurate urine test that can help in the diagnosis of AD. The AlzheimAlert test detects the presence of a brain protein--neural thread protein (NTP)--which is elevated in the urine of patients with Alzheimer's disease.

The test AlzheimAlert was developed and produced by Nymox Pharmaceutical Corp. (Hasbrouck Heights, NJ, USA). A positive report on AlzheimAlert was published in the January 2008 issue of the journal Expert Review of Molecular Diagnostics. The article was written by Ira Goodman, M.D., director of neurology, Orlando Regional HealthCare, Florida (Orlando, FL, USA) and associate clinical professor, departments of neurology and medicine, University of Florida School of Medicine (Gainesville, FL, USA). The article reviews the large number of basic research and clinical studies to date concerning the accuracy and specificity of the Nemox's urinary assay and documents several of Dr. Goodman's own clinical cases where the assay results proved useful in either arriving at a diagnosis of AD or in helping to rule it out.

One report involved a 39-year-old year male with an elevated AlzheimAlert result supportive of an AD diagnosis. Extensive testing confirmed a rare form of familial AD. A second of the researcher's cases involved a 54-year-old male with a history of cognitive decline and an elevated AlzheimAlert result. Eventually, a brain biopsy confirmed the diagnosis. In other cases described in the article, negative AlzheimAlert results helped to lead to other diagnoses, which were not AD.

The test has the CE Mark, allowing it to be marketed in Europe, and is also available to physicians in the United States through the company's Clinical Laboratory Improvement Amendments- (CLIA)-approved clinical reference laboratory. Data showing the high clinical accuracy and utility of the test have been frequently reported in the peer-reviewed literature, including the Journal of Clinical Laboratory Analysis (Volume 8, 2007) and the Journal of the American Medical Directors Association (Volume 21, 2007).


Related Links:
Orlando Regional HealthCare
University of Florida School of Medicine
Nymox Pharmaceutical Corp

Latest Clinical Chem. News