An 8-week open label trial of l-Threonic Acid Magnesium Salt in patients with mild to moderate dementia

Emerging research on the effects of a novel magnesium compound of l-Threonic Acid Magnesium Salt (l-TAMS) containing Vitamins C and D on cognitive performance suggests that supplementation may be of benefit to individuals with Alzheimer's disease (AD). The current open label trial explored l-TAMS effects in patients with mild to moderate probable AD. Fifteen patients with a clinical diagnosis of mild-to-moderate AD underwent 18F-FDG-PET imaging and neuropsychological testing, and blood draws at baseline and after 8 weeks of treatment in order to assess the acute effects of l-TAMS supplementation on cerebral glucose metabolism and cognitive performance. Neuropsychological testing and blood chemistries were also performed after 4 months of l-TAMS discontinuation. We did not find metabolic changes in apriori ROIs associated with AD rather, exploratory analyses showed statistical brain maps of cerebral-to-whole brain increases in regions not associated with AD. However, these findings were uncorrected for multiple comparisons and none of the findings survived multiple region comparisons. Although this study was underpowered to detect cognitive changes, a significant increase was found in MMSE scores after 8 weeks of l-TAMS treatment. No significant changes were found on other cognitive measures. The results of this study need to be interpreted with caution given significant study limitations including possible Type I error due to multiple comparisons, no comparison placebo group, and small sample size. Larger and longer, randomized placebo-controlled trials are needed to clarify whether l-TAMS treatment has significant effects on cognitive or relevant biomarkers in persons affected by or at risk for AD.