IRB approves Anatabloc clinical study
Star Scientific has received Institutional review board (IRB) approval for the first human clinical study using Anatabloc nutritional supplementation in patients with Alzheimer's disease.
Anatabloc is a dietary supplement that contains active dietary ingredients, anatabine citrate and vitamins A and D3, to provide anti-inflammatory support.
The study, entitled "A Three Month, Single-Site or Multi-Site, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Trial to Evaluate the Safety, Tolerability and Potential Effects of the Dietary Supplement Anatabine in Subjects with Alzheimer's Disease" is a six-visit double-blind randomised placebo-controlled parallel-group trial.
Performed in conjunction with the Roskamp Institute of Sarasota, US, the study is expected to enroll 120 subjects to evaluate the safety, tolerability, and potential effects of Anatabloc dietary supplementation on Alzheimer's.
The trial's secondary objective is to assess the effects of the specially formulated version of Anatabloc (patent pending) on amyloid beta (AB), global outcome, and functional measures of AD.