A dose-finding study to address safety (and efficacy) of Vorinostat in Alzheimer‘s Disease
Background and aims
This project aims assess the safety, tolerability of Vorinostat in the elderly population and to obtain first exploratory data on the efficacy of Vorinostat in improving cognition and memory in patients with mild symptomatic forms of Alzheimer’s disease.
Vorinostat was approved by the FDA in 2006 for the treatment of refractory cutaneous T-cell lymphoma (CTCL). Vorinostat is not approved for the treatment of Alzheimer’s disease, and no results are available with regard to the tolerability in elderly patients. This study is based on animal experimental data showing an improvement of memory function after the administration of Vorinostat.
Course of the study
Safety and tolerability will be assessed by physical examinations, electrocardiograms (ECGs), laboratory tests, and vital signs. Experimental data on efficacy will be determined based on cognitive and functional scales. In addition study participants will be asked to undergo a magnetic resonance imaging.
A full set of information about the study can be downloaded here (in German only): Flyer Vorinostat_AD