Movement disorders : official journal of the Movement Disorder Society
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Randomized Controlled Trial Multicenter Study
Phase II safety, tolerability, and dose selection study of isradipine as a potential disease-modifying intervention in early Parkinson's disease (STEADY-PD).
Isradipine, a dihydropyridine calcium channel antagonist, has been shown to be neuroprotective in animal models of Parkinson's disease (PD). To establish a dosage of isradipine controlled-release (CR) that is tolerable and demonstrates preliminary efficacy for use in a future pivotal efficacy trial a Phase 2, randomized, double-blind, parallel group trial (Safety, Tolerability and Efficacy Assessment of Dynacirc CR in Parkinson Disease [STEADY-PD]) was undertaken in subjects with early PD not requiring dopaminergic therapy (dopamine agonists or levodopa) randomized 1:1:1:1 to 5, 10, or 20 mg of isradipine CR or matching placebo daily. The primary outcome was tolerability defined as no more than a 30% difference in the proportion of patients completing the study on the originally assigned dosage between an active and placebo group. ⋯ The most common adverse events were peripheral edema (30) and dizziness (24). Isradipine 10 mg daily was the maximal tolerable dosage in this study of early PD. A large placebo-controlled trial will be necessary and is planned to assess efficacy of isradipine 10 mg daily to slow progression of PD disability.
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Multicenter Study
Dementia in Parkinson's disease: usefulness of the pill questionnaire.
The Level I algorithm for the diagnosis of dementia associated with Parkinson's disease (PD-D) recommended by the Movement Disorder Society task force includes a Pill Questionnaire to determine the impact of cognitive decline on daily activities. The objective of this study was to test the performance of the Pill Questionnaire as a screening tool for the detection of dementia (all-cause) in patients with PD and to test the performance of another functional scale substituting the Pill Questionnaire for the diagnosis of "probable PD-D" (pPD-D). Data were collected from 529 patients who had PD in Hoehn and Yahr stages 1 through 5. ⋯ When the Pill Questionnaire was substituted by the categorized SCOPA-Motor subscale, the modified algorithm showed sensitivity, specificity, and accuracy indexes over 90% but had positive predictive value of 66% for pPD-D diagnosis. Although the Pill Questionnaire demonstrated acceptable basic properties as a screening tool for dementia, its positive predictive value was low. The SCOPA-Motor subscale cannot be proposed as a substitute for the Pill Questionnaire.