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Prion research Göttingen

“A randomized, placebo-controlled double blind study aiming to evaluate the efficacy of orally administered Doxycycline in patients with Creutzfeldt-Jakob disease “

Project: The Creutzfeldt-Jakob-disease (CJD) is a subacute encephalopathy with a lethal outcome, for which there is currently no adequate therapy available. This study being in the second phase trial shall prove the efficacy of Doxycycline in comparison to placebo to the survival time of CJD patients. While an antiprion effect could be proven for Doxycyclin in vitro and in the animal trial, the placebo-comparative group should reflect the effect on disease evolution and survival.

Further objectives will be the evaluation of the effects of Doxycyclin on the disease progression, in particular the decline of the neurological and cognitive status, the level of invalidity and consciousness (according to assessed scores in functional scales).

Prior to inclusion into the study, all patients will be examined by a study physician from the National Surveillance Unit for CJD in Goettingen. Those patients fulfilling the inclusion-criteria and after written informed consent (possible, probable or definite CJD according to the WHO-criteria) will be randomized to one of the treatment arms:  Doxycyclin or the placebo group. The patients then receive a daily medication administered by oral route being either 100mg of doxycyclin or the placebo. Both, study physicians and patients are blinded to medication.

Patients will receibve a regular follow up by a physican or a study nurse of the University Clinic of Goettingen to assess the clinical status and to monitor the study. Every eight weeks during the first 24 weeks, the patients will be undergoing visits for physical examination and then every twelve week. The study will be carried out over a period of 3.5 years and a total of 180 patients are planned to be enrolled.