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

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

J Neurol Neurosurg Psychiatry. 2017 Feb;88(2):119-125

Authors: Varges D, Manthey H, Heinemann U, Ponto C, Schmitz M, Schulz-Schaeffer WJ, Krasnianski A, Breithaupt M, Fincke F, Kramer K, Friede T, Zerr I

Abstract
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.

PMID: 27807198 [PubMed - indexed for MEDLINE]

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