First human study of Anatabloc (Star Scientific) for Alzheimer's Disease

Star Scientific and its subsidiary Rock Creek Pharmaceuticals have received IRB approval for the first human clinical study of the safety and effects of nutritional supplementation with Anatabloc in individuals with Alzheimer's disease. Anatabloc contains 1 milligram of anatabine base, 500 units of Vitamin A and 40 units of Vitamin D3. Anatabine is a natural alkaloid found in Solanaceous plants (tomato, peppers, tobacco). The study will be undertaken in conjunction with the Roskamp Institute of Sarasota, Florida, which has been acting as a research partner in assessing the impact of Anatabloc on Alzheimer's Disease. Both the Rock Creek and Roskamp medical teams agreed that enough preliminary data was now available to initiate the study. The study is a six-visit, double-blind, randomized, placebo-controlled, parallel-group trial to evaluate the safety, tolerability, and potential effects of anatabine dietary supplementation in subjects with mild to moderate Alzheimer's Disease. Secondary aims are to evaluate the effects of this specially formulated version of Anatabloc on amyloid beta, global outcome, and functional measures of Alzheimer's Disease. The study will enroll subjects at least 65 years of age with a diagnosis of mild to moderate Alzheimer's Disease, and it is expected that a minimum of 120 subjects will complete the trial.