Rasagiline-associated motor improvement in PD occurs without worsening of cognitive and behavioral symptoms. J Neurol Sci 2006 Oct 25;248(1-2):78-83
Date
07/11/2006Pubmed ID
16828804DOI
10.1016/j.jns.2006.05.014Scopus ID
2-s2.0-33750480538 (requires institutional sign-in at Scopus site) 44 CitationsAbstract
BACKGROUND: Cognitive and behavioral adverse events (AEs) such as hallucinations, confusion, depression, somnolence and other sleep disorders commonly limit effective management of motor symptoms in PD. Rasagiline (N-propargyl-1(R)-aminoindan) mesylate is a novel, second-generation, selective, irreversible monoamine oxidase type B inhibitor, demonstrated in monotherapy and adjunctive trials to be effective for PD with excellent tolerability.
METHODS: The occurrence of cognitive and behavioral AEs and the change from baseline in the Unified Parkinson's Disease Rating Scale (UPDRS) part I mental subscores were reviewed in two multicenter, randomized, placebo-controlled, 26-week trials of rasagiline for early and moderate-to-advanced patients with PD. The UPDRS is a multi-item rating scale specific to PD; part I rates the patient's intellectual impairment, thought disorders, depression and motivation/initiative.
RESULTS: The TEMPO study evaluated rasagiline monotherapy in early PD patients (n=404). The PRESTO study evaluated rasagiline as adjunctive therapy in moderate-to-advanced PD patients with motor complications who were receiving optimized levodopa/carbidopa (n=472). In the analysis of adverse event reporting for both studies, no cognitive and behavioral AE in either the rasagiline 1 mg or placebo groups exceeded 10% of the study population and the frequency differences between rasagiline 1 mg and placebo never exceeded 3%. There was no adverse effect on the UPDRS mental subscore relative to placebo in either of the two studies.
CONCLUSION: Rasagiline 1 mg once daily improves PD symptoms and motor fluctuations in early and moderate-to-advanced PD patients without causing significant cognitive and behavioral AE or adverse changes in mentation, behavior and mood.
Author List
Elmer L, Schwid S, Eberly S, Goetz C, Fahn S, Kieburtz K, Oakes D, Blindauer K, Salzman P, Oren S, Prisco UL, Stern M, Shoulson I, Parkinson Study Group TEMPO, PRESTO InvestigatorsAuthor
Karen A. Blindauer MD Chief, Professor in the Neurology department at Medical College of WisconsinMESH terms used to index this publication - Major topics in bold
AgedBehavioral Symptoms
Case-Control Studies
Cognition
Dopamine Agents
Double-Blind Method
Female
Humans
Indans
Levodopa
Male
Middle Aged
Monoamine Oxidase Inhibitors
Neuropsychological Tests
Parkinson Disease