Doxycycline in early CJD: a double-blinded randomised phase II and observational study.

Autor: Varges, Daniela, Manthey, Henrike, Heinemann, Uta, Ponto, Claudia, Schmitz, Matthias, Schulz-Schaeffer, Walter J., Krasnianski, Anna, Breithaupt, Maren, Fincke, Fabian, Kramer, Katharina, Friede, Tim, Zerr, Inga
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Zdroj: Journal of Neurology, Neurosurgery & Psychiatry; Feb2017, Vol. 88 Issue 2, p119-125, 7p, 1 Diagram, 3 Charts, 2 Graphs
Abstrakt: Objectives: The main objective of the present study is to study the therapeutic efficiency of doxycycline in a double-blinded randomised phase II study in a cohort of patients with sporadic Creutzfeldt-Jakob disease (sCJD).Methods: From the National Reference Center of TSE Surveillance in Germany, patients with probable or definite sCJD were recruited for a double-blinded randomised study with oral doxycycline (EudraCT 2006-003934-14). In addition, we analysed the data from patients with CJD who received compassionate treatment with doxycycline in a separate group. Potential factors which influence survival such as age at onset, gender, codon 129 polymorphism and cognitive functions were evaluated. The primary outcome measure was survival.Results: Group 1: in the double-blinded randomised phase II study, 7 patients in the treatment group were compared with 5 controls. Group 2: 55 patients with sCJD treated with oral doxycycline were analysed and compared with 33 controls by a stratified propensity score applied to a Cox proportional hazard analysis. The results of both studies were combined by means of a random-effects meta-analysis. A slight increase in survival time in the doxycycline treatment group was observed (p=0.049, HR=0.63 (95% CI 0.402 to 0.999)).Conclusions: On the basis of our studies, a larger trial of doxycycline should be performed in persons in the earliest stages of CJD.Trial Registration Number: EudraCT 2006-003934-14; Results. [ABSTRACT FROM AUTHOR]
Databáze: Complementary Index