Study Shows Drug to Treat and Prevent Alzheimer ’s Is Safe and Well-Tolerated

A Phase I clinical trial to test the safety, pharmacokinetics and biomarker changes in amyloid peptides in the cerebrospinal fluid has shown that NGP 555, a drug developed to treat and prevent Alzheimer’s disease, was safe and well-tolerated with dose-dependent plasma exposure. NGP 555 is believed to act by decreasing the levels of the plaque-forming amyloid, Abeta42, while increasing shorter, nontoxic forms such as Abeta37. The 14-day multiple ascending dose clinical trial was a randomized, placebo-controlled, double-blind study in healthy volunteers aged 40 to 65. Patients were dosed at 100 mg to 400 mg, after which analysis of Abetaalofoms in cerebrospinal fluid was measured using Mesoscale ELISA technology in a subset of subjects. Subjects showed a 51 percent favorable change in Abeta37/ Abeta42 ratios at day 14 compared to baseline predrug levels for 400 mg (two subjects) and 36 percent for 200 mg (four subjects) versus 2 percent for placebo (one subject). In addition, a pharmacokinetic relationship was established with CSF biomarker changes.

The preclinical findings on NGP 555 were published in the Alzheimer’s & Dementia Journal: Translation Research and Clinical Intervention online version published Oct. 14, 2016.