A Randomized Controlled Trial of Etilevodopa in Patients With Parkinson Disease Who Have Motor Fluctuations

Blindauer, Karen; Shoulson, Ira; Oakes, David; Kieburtz, Karl; Schwid, Steven R.; Fahn, Stanley; Stern, Matthew B.; Goetz, Christopher G.; Nutt, John G.; Goren, Sari; Sayag, N.; Scolnik, M.; Levy, R.; Eyal, Eli; Salzman, Phyllis M.; Pagano, Mary

doi:10.1001/archneur.63.2.210

Cited by 28 publications

(1 citation statement)

References 9 publications

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“…OFF-time is measured by part IV of the Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) ( 2 ). Annually, 10% of patients develop MRMF and response failures when no symptomatic benefit occurs after taking levodopa ( 5 ). Long-term treatment results in MRMF in most patients ( 6 ).…”

Section: Introductionmentioning

confidence: 99%

Rationale and Design of the PAIRED Trial: Partnered Dance Aerobic Exercise as a Neuroprotective, Motor, and Cognitive Intervention in Parkinson's Disease

et al. 2020

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Parkinson's disease (PD), an intractable condition impairing motor and cognitive function, is imperfectly treated by drugs and surgery. Two priority issues for many people with PD are OFF-time and cognitive impairment. Even under best medical management, three-fourths of people with PD experience “OFF-time” related to medication-related motor fluctuations, which severely impacts both quality of life and cognition. Cognitive deficits are found even in newly diagnosed people with PD and are often intractable. Our data suggest that partnered dance aerobic exercise (PDAE) reduces OFF-time on the Movement Disorders Society Unified Parkinson Disease Rating Scale-IV (MDS-UPDRS-IV) and ameliorates other disease features, which motivate the PAIRED trial. PDAE provides AE during an improvisational, cognitively engaging rehabilitative physical activity. Although exercise benefits motor and cognitive symptoms and may be neuroprotective for PD, studies using robust biomarkers of neuroprotection in humans are rare. We propose to perform a randomized, controlled trial in individuals with diagnosed mild–moderate PD to compare the efficacy of PDAE vs. walking aerobic exercise (WALK) for OFF-time, cognition, and neuroprotection. We will assess neuroprotection with neuromelanin-sensitive MRI (NM-MRI) and iron-sensitive (R2 * ) MRI sequences to quantify neuromelanin loss and iron accumulation in substantia nigra pars compacta (SNc). We will use these biomarkers, neuromelanin loss, and iron accumulation, as tools to chart the course of neurodegeneration in patients with PD who have undergone long-term (16 months) intervention. We will randomly assign 102 individuals with mild–moderate PD to 16 months of PDAE or WALK. The 16-month intervention period will consist of Training (3 months of biweekly sessions) and Maintenance (13 months of weekly sessions) phases. We will assess participants at baseline, 3 months (immediately post-Training), and 16 months (immediately post-Maintenance) for OFF-time and behaviorally and physiologically measured cognition. We will acquire NM-MRI and R2 * imaging data at baseline and 16 months to assess neuroprotection. We will (1) examine effects of Training and Maintenance phases of PDAE vs. WALK on OFF-time, (2) compare PDAE vs. WALK at 3 and 16 months on behavioral and functional MRI (fMRI) measures of spatial cognition, and (3) compare PDAE vs. WALK for effects on rates of neurodegeneration.

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Section: Introductionmentioning

confidence: 99%

Rationale and Design of the PAIRED Trial: Partnered Dance Aerobic Exercise as a Neuroprotective, Motor, and Cognitive Intervention in Parkinson's Disease

et al. 2020

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Late (Complicated) Parkinson's Disease

Oertel

Berardelli

Bloem

et al. 2010

European Handbook of Neurological Management

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How do you treat motor complications in Parkinson's disease: Medicine, surgery, or both?

Fahn

2009

Ann Neurol.

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The motor complications associated with levodopa therapy, namely, fluctuations in motor response and dyskinesias, occur in the majority of Parkinson's disease patients. These complications can impair a patient's quality of life and even cause pronounced disability. "Off" states that result in freezing of gait and falling are disabling for many patients. Dyskinesias most commonly occur at peak dose and typically alternate with the wearing-off state. Once these problems appear, they usually persist, and the physician needs to make continual adjustments in medications to minimize these problems. Medical treatments should be attempted before treatments such as deep brain stimulation are considered because of the potential adverse effects that are associated with surgery. The timing of surgery, however, is also important because younger patients and less advanced patients tend to have a better outcome. There is thus a need for experienced and knowledgeable physicians and surgeons who are able to handle these motor complications. This review discusses available medications and surgical approaches, and their outcomes.

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A Randomized Controlled Trial of Etilevodopa in Patients With Parkinson Disease Who Have Motor Fluctuations

Cited by 28 publications

References 9 publications

Rationale and Design of the PAIRED Trial: Partnered Dance Aerobic Exercise as a Neuroprotective, Motor, and Cognitive Intervention in Parkinson's Disease

Rationale and Design of the PAIRED Trial: Partnered Dance Aerobic Exercise as a Neuroprotective, Motor, and Cognitive Intervention in Parkinson's Disease

Late (Complicated) Parkinson's Disease

How do you treat motor complications in Parkinson's disease: Medicine, surgery, or both?

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