Phase II trial of Adamant is a randomized, double-blind, placebo-controlled trial in mild Alzheimer's disease. The primary objective was safety, the secondary objectives were immunogenicity assessment and efficacy based on clinical outcomes and key biomarkers. Axon studied AADvac1 in 196 patients in eight European countries over a 24-month period to demonstrate the effect of a disease-modifying vaccine and to support the design of future confirmatory studies.
The findings of the study showed that AADvac1 was shown to be safe and well tolerated: There was no difference in the frequency and type of adverse events between the vaccine-treated and placebo-treated groups. The overall good safety profile of AADvac1 has been demonstrated in previous clinical trials.
The vaccine uses the body's immune system to produce specific antibodies against "unhealthy dew." In a phase II study, treatment was found to be very effective in inducing an immune response: 98.2 percent of patients produced antibodies to pathological dew. Tau proteins play an important role in healthy, normal brain function. Alzheimer's disease begins when normal tau proteins become pathological through shortening: change and structure and function. Unhealthy tau proteins bind to each other and form clots, which spread to the brain and cause disease. The distribution of these clots shows a strong correlation with clinical symptoms in patients.