The trial will be expanded by 30 to 60 participants, an increase of up to 40% from the number originally planned. The company also has earmarked an additional $2 million in funding for the study. Neuro-Hitech has already completed two phase I studies and reached the original enrollment goal of 150 patients in the phase II trials of Huperzine A.
“The primary reason for increasing enrollment is to boost the predictive power of the study in demonstrating the effect of Huperzine A on cognitive performance,” said Dr Paul Aisen, professor of neurology at Georgetown University Medical Center.
“Another key benefit of expanded enrollment is to improve the power of secondary analyses assessing, for example, the impact of Huperzine A on behavior and function,” Dr Aisen added.
Neuro-Hitech said that by expanding the trial it now has a projected completion date of late 2007.