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GLEN ALLEN, Va.,
Aug. 23, 2012 /PRNewswire/ -- Star Scientific, Inc. (NASDAQ: STSI), through its wholly owned subsidiary Rock Creek Pharmaceuticals Inc., announced today that the Alzheimer's study of the company's dietary supplement Anatabloc
® has screened and enrolled its first patient.
The Alzheimer's study, entitled, "
A Three Month, Multi-Site, Double Blind, Randomized, Placebo-Controlled, Parallel-Group Trial to Evaluate the Safety, Tolerability and Potential Effect of the Dietary Supplement Anatabine in Subjects with Alzheimer's Disease," has its origins in basic research conducted at the Roskamp Institute (
Sarasota, FL) and from case reports of beneficial effects of the company's dietary supplement Anatabloc® in individuals using the nutritional supplement under their physician's care.
The anatabine citrate used in Anatabloc® has been shown to be effective in lowering amyloid levels and other markers of inflammation in both tissue studies conducted in a laboratory setting and in animal research. In addition, Anatabloc® has been reported by others to be a useful nutritional supplement in Alzheimer's disease. The company received a patent for the synthesis of anatabine in
June 2012, and a patent is pending for the Anatabloc® formulation. Preparations for the Alzheimer's study were extensive and included pharmacokinetic and tolerability studies, a review of the safety of Anatabloc® in other clinical trials that had the same usage level as in the Alzheimer's study, and a review of post-marketing reports for the Anatabloc® product itself.
The study will enroll 120 subjects with mild to moderate Alzheimer's disease and randomize these patients, who will then receive, on a blinded basis, either the active Anatabloc® supplement or a placebo. The subjects then will be monitored throughout the course of their assigned treatment to evaluate tolerability, safety, blood levels of inflammatory markers, and functional status. The intent of the study is to determine the safety of Anatabloc® in this population, and determine if there is evidence of a reduction in inflammatory markers or a change in functional status.