Chapter 9 Clinical Trials in Parkinson's Disease

Ergun Y. Uc; Andrea J. DeLeo; Robert L. Rodnitzky

doi:10.1016/S1877-3419(09)70016-9

This chapter discusses clinical trials in Parkinson's disease (PD). PD represents the prototypic hypokinetic movement disorder. It is the most commonly seen hypokinetic movement disorder in clinical practice, affecting 100–105 individuals per 100,000, or approximately 1% of the U.S. population that is 60 years of age and older. Clinical trials involving PD present several unique challenges. One of the difficulties encountered in conducting clinical trials in PD is the accuracy of clinical diagnosis of study participants, as no validated diagnostic test for the condition exists and rather the diagnosis is made on clinical grounds alone. Other neurodegenerative parkinsonian syndromes, such as progressive supranuclear palsy, multisystem atrophy, and corticobasal ganglionic degeneration, can be misdiagnosed as idiopathic PD. In an autopsy study of 100 patients diagnosed with PD during life, diagnostic clinicopathologic correlation was demonstrated in only 82% of cases. Another challenge in clinical trials involving PD is the accurate assessment of improvement or deterioration. Because there is no readily available reliable biologic marker of disease severity, clinical trials have largely depended on clinical assessment as measures of improvement or progression. In this regard, difficulty can be encountered when evaluating therapeutic efficacy or disease progression in PD because of the lack of correlation among the various rating scales used to assess clinical domains of the disease and the lack of inter-rater reliability among clinical examiners who apply these scales.

Chapter 9 Clinical Trials in Parkinson's Disease

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