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J Neurol Neurosurg Psychiatry. 2017 Feb;88(2):119-125. doi: 10.1136/jnnp-2016-313541. Epub 2016 Nov 2.

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

Author information

1
Department of Neurology, National Reference Center for TSE Surveillance, University Medical Center Goettingen, Göttingen, Germany.
2
Department of Neuropathology, University Medical Center Goettingen, Göttingen, Germany.
3
Department of Medical Statistics, University Medical Center Goettingen, Göttingen, Germany.

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
PMCID:
PMC5284486
DOI:
10.1136/jnnp-2016-313541
[Indexed for MEDLINE]
Free PMC Article

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