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@article{1364217, author = {Novak, Petr and Schmidt, Reinhold and Kontsekova, Eva and Zilka, Norbert and Kovacech, Branislav and Skrabana, Rostislav and VinceandKazmerova, Zuzana and Katina, Stanislav and Fialova, Lubica and Prcina, Michal and Parrak, Vojtech and DalandBianco, Peter and Brunner, Martin and Staffen, Wolfgang and Rainer, Michael and Ondrus, Matej and Ropele, Stefan and Smisek, Miroslav and Sivak, Roman and Winblad, Bengt and Novak, Michal}, article_location = {London, UK}, article_number = {2}, doi = {http://dx.doi.org/10.1016/S1474-4422(16)30331-3}, keywords = {Alzheimer's disease; a randomised; double-blind; placebo-controlled; phase 1 trial}, language = {eng}, issn = {1474-4422}, journal = {Lancet Neurology}, note = {Žádný z autorů nemá afiliaci na MU.}, title = {Safety and immunogenicity of the tau vaccine AADvac1 in patients with Alzheimer's disease: a randomised, double-blind, placebo-controlled, phase 1 trial}, url = {http://www.sciencedirect.com/science/article/pii/S1474442216303313}, volume = {17}, year = {2016} }
TY - JOUR ID - 1364217 AU - Novak, Petr - Schmidt, Reinhold - Kontsekova, Eva - Zilka, Norbert - Kovacech, Branislav - Skrabana, Rostislav - Vince-Kazmerova, Zuzana - Katina, Stanislav - Fialova, Lubica - Prcina, Michal - Parrak, Vojtech - Dal-Bianco, Peter - Brunner, Martin - Staffen, Wolfgang - Rainer, Michael - Ondrus, Matej - Ropele, Stefan - Smisek, Miroslav - Sivak, Roman - Winblad, Bengt - Novak, Michal PY - 2016 TI - Safety and immunogenicity of the tau vaccine AADvac1 in patients with Alzheimer's disease: a randomised, double-blind, placebo-controlled, phase 1 trial JF - Lancet Neurology VL - 17 IS - 2 SP - 1-12 EP - 1-12 PB - Elsevier SN - 14744422 N1 - Žádný z autorů nemá afiliaci na MU. KW - Alzheimer's disease KW - a randomised KW - double-blind KW - placebo-controlled KW - phase 1 trial UR - http://www.sciencedirect.com/science/article/pii/S1474442216303313 L2 - http://www.sciencedirect.com/science/article/pii/S1474442216303313 N2 - Neurofibrillary pathology composed of tau protein is a main correlate of cognitive impairment in patients with Alzheimer's disease. Immunotherapy targeting pathological tau proteins is therefore a promising strategy for disease-modifying treatment of Alzheimer's disease. We have developed an active vaccine, AADvac1, against pathological tau proteins and assessed it in a phase 1 trial. We did a first-in-man, phase 1, 12 week, randomised, double-blind, placebo-controlled study of AADvac1 with a 12 week open-label extension in patients aged 50–85 years with mild-to-moderate Alzheimer's disease at four centres in Austria. We randomly assigned patients with a computer-generated sequence in a 4:1 ratio overall to receive AADvac1 or placebo. They received three subcutaneous doses of AADvac1 or placebo from masked vaccine kits at monthly intervals, and then entered the open-label phase, in which all patients were allocated to AADvac1 treatment and received another three doses at monthly intervals. Patients, carers, and all involved with the trial were masked to treatment allocation. The primary endpoint was all-cause treatment-emergent adverse events, with separate analyses for injection site reactions and other adverse events. We include all patients who received at least one dose of AADvac1 in the safety assessment. Patients who had a positive IgG titre against the tau peptide component of AADvac1 at least once during the study were classified as responders. The first-in-man study is registered with EU Clinical Trials Register, number EudraCT 2012-003916-29, and ClinicalTrials.gov, number NCT01850238; the follow-up study, which is ongoing, is registered with EU Clinical Trials Register, number EudraCT 2013-004499-36, and ClinicalTrials.gov, number NCT02031198. ER -
NOVAK, Petr, Reinhold SCHMIDT, Eva KONTSEKOVA, Norbert ZILKA, Branislav KOVACECH, Rostislav SKRABANA, Zuzana VINCE-KAZMEROVA, Stanislav KATINA, Lubica FIALOVA, Michal PRCINA, Vojtech PARRAK, Peter DAL-BIANCO, Martin BRUNNER, Wolfgang STAFFEN, Michael RAINER, Matej ONDRUS, Stefan ROPELE, Miroslav SMISEK, Roman SIVAK, Bengt WINBLAD a Michal NOVAK. Safety and immunogenicity of the tau vaccine AADvac1 in patients with Alzheimer's disease: a randomised, double-blind, placebo-controlled, phase 1 trial. \textit{Lancet Neurology}. London, UK: Elsevier, 2016, roč.~17, č.~2, s.~1-12. ISSN~1474-4422. Dostupné z: https://dx.doi.org/10.1016/S1474-4422(16)30331-3.
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