Alzheimer's is an irreversible and progressive brain disorder that affects memory and thinking skills, eventually rendering most patients unable to perform everyday tasks. But a leading clinical-stage biotech company has published full phase II results of its tau vaccine AADvac1 against Alzheimer's disease, with positive results. The Adamant, 24-month randomized, placebo-controlled, trial, was conducted to assess the safety and efficacy of the AADvac1 vaccine in patients with mild Alzheimer's. Whereas the primary objectives were to evaluate the safety and tolerability of long-term AADvac1 treatment, secondary objectives included immunogenicity and evaluation of vaccine efficacy in slowing cognitive and functional decline. The vaccine was found to be most effective on a subgroup of patients with a confirmed Alzheimer's disease biomarker profile.
Axion NeuroscienceA clinical-stage biotech company at the fore in the treatment and prevention of Alzheimer's disease conducted the study. For this, the company recruited 196 patients from eight European countries.
The results of its completed Phase II study were: published In the journal Nature Aging. The report's abstract stated: "Alzheimer's disease (AD) pathology is partly characterized by the accumulation of abnormal forms of the tau protein. Here, we present a 24-month double-blind, parallel-arm, randomized phase 2 multi-lineage assay of AADvac1. Centers report the results of the placebo-controlled trial ADAMANT.
According to the published results, AADvac1 was safe and tolerable. What's more, the vaccine reduced the accumulation of neurofilament light chain (NFL), an important biomarker of neurodegeneration, in the blood by 58 percent.
In the subgroup of patients with a confirmed Alzheimer's disease biomarker profile, according to the study, aADVAC1 slowed clinical decline by 27 percent as measured by CDR-SB and by 30 percent in functional decline as measured by aDCS-MCI-ADL. done.
Compared to placebo, the vaccine significantly reduced NFL blood levels by 62 percent (p value = 0.010).
"The vaccine induced high levels of IgG antibodies. No significant effects were found in cognitive and functional tests on the entire study sample (Clinical Dementia Rating-Box Scale Sum Adjusted Mean Point Difference -0.360 (95% CI -1.306, 0.589) )), custom cognitive battery-adjusted mean z-score difference of 0.0008 (95% CI -0.169, 0.172)," read the paper's abstract.
one in Press releaseMichael Fraser, CEO of Axon Neuroscience, said, "Our Phase II trial successfully demonstrated the strength of our key asset AADvac1, a tau vaccine on track to prevent and treat Alzheimer's disease," and added, "The results are disease-modifying. confirm the effect of AADvac1".
The website also has a quote from Fraser stating that "the very positive results from our landmark Phase II clinical trial undermine our confidence, and strengthen our motivation to get patients treated as soon as possible".