On 14 June, Dr. Petr Novak and colleagues at Axon Neuroscience published the results of the ADAMANT Phase II clinical trial, in the Nature Aging journal. ADAMANT was a 24-month randomised, placebo-controlled trial that aimed to assess the safety and efficacy of AADVac1 in participants with mild Alzheimer's disease (AD). AADVac1 is a peptide vaccine directed against an area of the tau protein that is involved in the formation of tau tangles, which accumulate in the brain during the development of AD. Preclinical studies of AADVac1 showed that rats which received regular doses of AADVac1 had much less evidence of AD pathology in the brain, with substantially fewer tau tangles and improved performance on cognitive and functional tests. Results of a Phase I clinical trial of AADVac1 revealed that the treatment was safe and well-tolerated by participants, with a trend towards improved performance in certain cognitive tests. ADAMANT initiated recruitment in 2016, enrolling 196 participants with mild to moderate AD, 117 of whom received AADVac1 (11 doses over the 24-month trial period).
Similar to the results of the Phase I trial, ADAMANT found that AADVac1 was safe and well-tolerated, with similar numbers of adverse events reported by the treatment and placebo groups. AADVac1 was able to stimulate the immune system to produce high levels of antibodies against tau. This was associated with significant reductions in the levels of biomarkers of neurodegeneration, including neurofilament light chain (NfL) and pTau217. The researchers did not observe any substantial improvements overall in cognitive or functional tests following treatment with AADVac1, although closer analysis of participant subgroups identified a 30% reduction in cognitive and functional decline (measured by CDR-SB and ADAS-MCI-ADL tests) among those with a confirmed AD biomarker profile.
https://www.axon-neuroscience.eu/src/pr/nature-aging-axon-results.pdf