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Doxycycline in early CJD: a double-blinded randomised phase II and observational study
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,...
Autores principales: | , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2017
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5284486/ https://www.ncbi.nlm.nih.gov/pubmed/27807198 http://dx.doi.org/10.1136/jnnp-2016-313541 |
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author | 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 |
author_facet | 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 |
author_sort | Varges, Daniela |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-5284486 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-52844862017-02-07 Doxycycline in early CJD: a double-blinded randomised phase II and observational study 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 J Neurol Neurosurg Psychiatry Neurodegeneration 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. BMJ Publishing Group 2017-02 2016-11-02 /pmc/articles/PMC5284486/ /pubmed/27807198 http://dx.doi.org/10.1136/jnnp-2016-313541 Text en Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/ This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ |
spellingShingle | Neurodegeneration 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 Doxycycline in early CJD: a double-blinded randomised phase II and observational study |
title | Doxycycline in early CJD: a double-blinded randomised phase II and observational study |
title_full | Doxycycline in early CJD: a double-blinded randomised phase II and observational study |
title_fullStr | Doxycycline in early CJD: a double-blinded randomised phase II and observational study |
title_full_unstemmed | Doxycycline in early CJD: a double-blinded randomised phase II and observational study |
title_short | Doxycycline in early CJD: a double-blinded randomised phase II and observational study |
title_sort | doxycycline in early cjd: a double-blinded randomised phase ii and observational study |
topic | Neurodegeneration |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5284486/ https://www.ncbi.nlm.nih.gov/pubmed/27807198 http://dx.doi.org/10.1136/jnnp-2016-313541 |
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