Alzheimer’s Vaccine Found Safe, Effective in Patients with Mild Forms of the Disease, Phase 2 Study Finds

Alzheimer’s Vaccine Found Safe, Effective in Patients with Mild Forms of the Disease, Phase 2 Study Finds
AXON Neuroscience’s investigational AADvac1 vaccine against tau protein, a hallmark of Alzheimer’s disease, was found safe and effective at lessening signs of neurodegeneration in patients with mild Alzheimer’s, according to the results of a Phase 2 trial. Among younger study participants, the vaccine also seemed to improve certain cognitive outcomes. Intracellular tangles of tau protein are associated with neuronal loss and with severity of dementia. Immunotherapy using the AADvac1 vaccine is intended  to induce the patient’s immune system to produce specific antibodies against abnormal forms of tau, with the ultimate goal of protecting neurons from degeneration. The Phase 2 ADAMANT study (NCT02579252) randomized 196 patients with mild Alzheimer’s to receive ADDvac1 or a placebo. Patients were enrolled at 42 clinical centers in eight countries around Europe. The vaccine was given in a total of 11 doses. The first six doses were administered at four-week intervals. The remaining doses were given at three-month intervals. The trial’s main goal was to assess the vaccine’s safety. Additional goals included the vaccine’s immunogenicity (ability to produce an immune response) and effectiveness on clinical outcomes and disease biomarkers. The results showed that AADvac1 was safe and well-tolerated, with no differences in adverse side effects between the ADDvac1-treated and placebo groups. The vaccine induced a robust immune response, with 98.2% of patients generating antibodies against toxic forms of the tau protein. These findings are in agreement with
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