reaZin, formerly named Zinthionein, is a proprietary, gastroretentive, sustained release, once-daily oral tablet formulated from zinc (150 mg) and cysteine (100 mg), an amino acid with potent anti-oxidant properties.
The prospective, randomized, double-blind, placebo-controlled clinical study subjects were randomized into the active treatment group or the placebo group and were assessed at baseline, 3 months and 6 months.
The treatment group showed significant reductions in serum free copper levels and elevations in serum zinc levels over the placebo group, resulting in a highly statistically significant change in the free copper to zinc ratio (-20.8%), the primary outcome of the clinical study (p < 0.0006).
Adeona R&D SVP George Brewer said they are encouraged by the results from this clinical study, especially achieving the primary outcome with the statistically significant change in the free copper to zinc ratio in the treatment group over the placebo group.
Lead principal pnvestigator of the study at Morton Plant Neuroscience Institute on the campus of Morton Plant Hospital Diana Pollock said the zinc therapy appears to have been extremely well tolerated and may represent a new mechanism of action to address the cognitive deficits in Alzheimer’s patients.
Adeona CEO James Kuo said based on the favorable results presented from this clinical study, they intend to further the commercial development of reaZin as a prescription medical food for the dietary management of Alzheimer’s disease and mild cognitive impairment.
"In addition, we will be reviewing the results from our clinical study with our scientific advisors to determine what further clinical studies might be warranted to support additional labeling claims," Kuo said.