Scientists from Mount Sinai School of Medicine have found that drug rasagiline not only helps treat the symptoms of Parkinson's Disease, but also slows the rate of disease progression.
The study called ADAGIO (Attenuation of Disease Progression with Azilect Given Once Daily) showed that previously untreated PD patients randomized to initiate therapy with rasagiline (Azilect(r)) 1 mg per day had benefits at 18 months that were not achieved when the same drug was initiated at nine months.
It showed that the drug has a disease-modifying effect which slows disease progression.
The researchers examined both 1- and 2-mg doses of rasagiline using a rigorous design that included three primary endpoints. The 1-mg dose met all three primary endpoints. The 2-mg dose did not.
"The finding that early treatment with rasagiline 1 mg per day provides benefits that cannot be achieved with later administration of the same drug indicates that these benefits are not simply due to a symptomatic effect of the drug and are consistent with the possibility that the drug is disease-modifying," the New England Journal of Medicine quoted Dr C. Warren Olanow, Professor in the Department of Neuroscience and Director, Robert and John M. Bendheim Parkinson's Disease Centre, Mount Sinai School of Medicine, as saying.
"If this can be confirmed, this would be the first drug determined to have a disease-modifying effect in PD, and that is exciting news for the PD community," the expert added.
During the study, 1,176 patients with very early PD in 14 countries and 129 medical centers were randomized to receive rasagiline 1 or 2 mg per day for 72 weeks (early start) or placebo for 36 weeks followed by rasagiline 1 or 2 mg per day for 36 weeks (delayed start).
"We think the findings with rasagiline 1 mg per day must have had something to do with a disease-modifying property of the drug that manifested during the trial's 36-week placebo-controlled phase," said Olanow.
"The failure to get similar results with the 2-mg dose may be due to the greater symptomatic effects of this dose masking an underlying disease-modifying effect. Indeed, a subgroup analysis of rasagiline 2 mg per day in the most severely affected patients in the study did show positive effects," Olanow added.