Faculty Collaboration Database

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

07/11/2006

Pubmed ID

16828804

DOI

10.1016/j.jns.2006.05.014

Scopus ID

2-s2.0-33750480538 (requires institutional sign-in at Scopus site)   44 Citations

Abstract

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 Investigators

Author

Karen A. Blindauer MD Chief, Professor in the Neurology department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Aged
Behavioral Symptoms
Case-Control Studies
Cognition
Dopamine Agents
Double-Blind Method
Female
Humans
Indans
Levodopa
Male
Middle Aged
Monoamine Oxidase Inhibitors
Neuropsychological Tests
Parkinson Disease