Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced today enrollment of the first patient in the MODERATO study – a Phase IV clinical study designed to evaluate the effect of AZILECT ® (rasagiline tablets) on cognitive function in adults with mild cognitive impairment (MCI) in Parkinson's disease (PD-MCI).
“Cognitive impairment in PD is a major cause of disability and increased care partner burden,” said Robert A. Hauser, M.D., M.B.A., Director, Parkinson's Disease & Movement Disorders Center at the University of South Florida and co-primary investigator of the study. “As currently there are no available treatments for cognitive impairment in Parkinson's disease, any therapy that may demonstrate benefit would be welcomed for this significant unmet need.”
The MODERATO study ( Multicenter, Rand omized, Double-Blind, Placebo-Controlled Study to Assess the Effect of Rasagiline on Cognition in Patien ts with Parkins on’s disease) is the largest trial to-date to evaluate a treatment for PD-MCI. The multicenter study will evaluate the effect of rasagiline on cognitive function in adults with PD-MCI, as assessed by the Scales for Outcomes of Parkinson's Disease-Cognition (SCOPA-COG) after 24 weeks of treatment and will enroll approximately 170 patients at 30 sites across the United States.
“PD-MCI is common in non-demented PD patients and is associated with increasing age, disease duration and disease severity,” said Michael Hayden, M.D., President of Global R&D and Chief Scientific Officer for Teva Pharmaceutical Industries, Ltd. “MODERATO demonstrates Teva's ongoing commitment to research with AZILECT and the development of products aimed at meeting the specific needs of the CNS community.”PD is a slowly progressing degenerative disorder of the brain, characterized by tremor, stiffness, slowness of movement, and impaired balance. An estimated five million people worldwide suffer from the disease, with an average age of onset of about 60 years.