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Promising Data on Cognitive Effects of Safinamide in Early,Parkinson's Disease

an improvement in cognitive domains often impaired in these patients, in particular executive function (the ability for planning, organizing, strategizing and paying attention to and remembering details) and working memory.
Treatment with safinamide at a dose of 50 to 100 mg once daily over a 24-week period resulted in a statistically significant improvement in tests assessing executive function, such as the Strategic Target Detection Test2 (STDT), compared with dopamine agonist monotherapy. A statistically significant improvement was also observed in tests for working memory such as Auditory Number Sequencing3 (ANS). Tests assessing manual dexterity and attention/vigilance were not statistically different across treatment groups.
From baseline to the 24th week, cognitive data were available for 41 patients randomized to safinamide 50 to 100 mg once daily, 38 to safinamide 150 to 200 mg once daily and 44 to placebo. Cognitive effects were seen as early as 12 weeks after starting safinamide treatment. The higher safinamide dose range of 150 to 200 mg per day did not offer any incremental advantage over safinamide 50 to 100 mg per day dose range based on STDT and ANS.
The side effects observed in the safinamide group were similar to those observed in the placebo group. The most frequent side effects were gastro-intestinal disorders (nausea, vomiting, abdominal pain upper).

The cognitive effects of safinamide will be further investigated in other clinical trials.

Merck Serono has exclusive worldwide rights to develop, manufacture and commercialize safinamide in Parkinson’s disease, Alzheimer’s disease, other cognitive disorders and restless leg syndrome, as per the agreement signed with Newron in October 2006.
1 Phase III data presented at American Academy of Neurology 59th Annual Meeting in Boston, Massachusetts, USA:
The data are from a trial conducted in Europe, South America and Asia. A total of 2
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