Background

NIC5-15 is pinitol, a naturally occurring cyclic sugar alcohol. It is found in soy and several other plants and fruits. Pinitol is known to act as an insulin sensitizer. According to company press releases, the compound also modulates γ-secretase to reduce Aβ production while sparing cleavage of the γ-secretase substrate Notch. Company press releases say the compound improves cognitive function and memory deficits in preclinical models of AD neuropathology (see company website). No peer-reviewed papers on NIC5-15/pinitol have been published in the scientific literature. Pinitol is commercially available as a food supplement.

Findings

A Phase 2a trial at the VA Medical Center, Bronx, New York, and Icahn School of Medicine at Mt. Sinai, New York, assessed 1,500, 3,000, and 5,000 mg doses of NIC5-15 in 15 people with mild to moderate Alzheimer's disease over seven weeks for safety and efficacy (see MSSM website). This trial ended in 2008. At the 2009 ICAD conference in Vienna, preliminary results were reported to indicate good tolerability, as well as stabilization of cognition as measured by the ADAS-Cog. This trial was sponsored by the Department of Veterans Affairs, the National Center for Complementary and Alternative Medicine, and Humanetics Corporation.

In June 2012, the U.S. Patent and Trademark Office issued a patent for the use of D-pinitol in the treatment of Alzheimer's disease, and a second single-site Phase 2b study was begun. This trial is enrolling an estimated 40 patients with mild to moderate AD and assesses cognition, measured by ADAS-Cog as primary outcome. For all clinical trials of this compound, see clinicaltrials.gov.

Clinical Trial Timeline