Real-Time Levodopa Level Monitoring in Parkinson Disease

Официальное название

Real-Time Levodopa Monitoring for Improved Management of Parkinson Disease

Обзор

This project aims to develop a minimally invasive sensor device to monitor levodopa levels in real time. We will test the accuracy, tolerability, and safety of this device in people with Parkinson disease.

Подробное описание

People with Parkinson disease (PD) lack the chemical dopamine, which is important for movement. Levodopa replaces dopamine and restores normal motor function in PD. Early in the disease stages, people with PD benefit significantly from levodopa. However, as PD progresses, the brain loses more dopamine-producing cells, which causes motor complications and unpredictable responses to levodopa. To maintain control of symptoms over time, levodopa doses must be increased and given at increasingly shorter intervals. The optimal levodopa regimen is different for each person and may vary from day-to-day, depending on a variety of internal and external factors including meal consumption, activity level, and other lifestyle variances. Currently, clinicians assess levodopa's benefit by the patient's testimony and by clinical exam. However, these methods may not adequately represent the severity or range of complications experienced by the PD patient. Thus, it can be difficult to determine the optimal levodopa treatment regimen, which can cause suboptimal disease management and side effects.

This project aims to develop a continuous, minimally invasive sensor (the "Levodopameter") designed to measure levodopa levels in real time from body fluids (capillary blood, sweat, and interstitial fluid), with the future goals of identifying an individualized treatment regimen for people with PD to improve disease management.

We will compare levodopa levels measured by the Levodopameter to the impractical and expensive "gold standard" high-performance liquid chromatography (HPLC) analysis of plasma levodopa levels. We will first test the device after administering oral carbidopa/levodopa in 10 participants with PD. After that portion of the study is completed and safety confirmed, we will test the device in 10 participants with PD after administering carbidopa and intravenous levodopa. We will also evaluate the device's safety and tolerability.

The long-term goal of this device is to allow PD patients to take proactive measures to assess and maintain an optimal, personalized levodopa regimen, similar to diabetes care in which diabetic patients periodically self-monitor their glucose and adjust their insulin regimen accordingly.

Вмешательства

• Устройство Levodopameter
  There are several minimally-invasive sensors being developed that can detect levodopa levels in the capillary blood, sweat, and interstitial fluid.

Первичные конечные точки

• Levodopa Levels [Срок оценки: through study completion, an average of 12 months]

Вторичные конечные точки (2)

• Patient Acceptability of Levodopameter [Срок оценки: through study completion, an average of 12 months]
• Device Safety [Срок оценки: through study completion, an average of 12 months]

Критерии участия

Критерии включения

• Participants must meet the Movement Disorders Society (MDS) diagnostic criteria for clinically established Parkinson disease.
• Able to provide signed informed consent (in English or Spanish)
• Mild, moderate, or severe Parkinson disease, able to ambulate (Hoehn and Yahr stages I-IV)
• Taking instant release oral carbidopa/levodopa therapy
• Either not taking, or on stable doses of any of the following antiparkinsonian medications: dopamine agonists, monoamine oxidase B (MAO-B) inhibitors or catecholamine O-methyl transferase (COMT) inhibitors

Критерии исключения

• Other neurological conditions including but not limited to stroke, dementia (including Parkinson disease dementia), or traumatic brain injury
• Co-existent major psychiatric disease
• Uncontrolled, active medical conditions (e.g., heart, kidney, or liver failure, diabetes, etc.)
• Status post deep brain stimulation (DBS) device placement
• Any other condition, that in the opinion of the investigators, would place the participant at risk.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 1 центр

• University of California San DIego — San Diego

Публикации

• Goud KY, Moonla C, Mishra RK, Yu C, Narayan R, Litvan I, Wang J. Wearable Electrochemical Microneedle Sensor for Continuous Monitoring of Levodopa: Toward Parkinson Management. ACS Sens. 2019 Aug 23;4(8):2196-2204. doi: 10.1021/acssensors.9b01127. Epub 2019 Aug 12. PMID 31403773
• Brunetti B, Valdés-Ramírez G, Litvan I, Wang J. A disposable electrochemical biosensor for L-DOPA determination in undiluted human serum. Electrochemistry Communications 2014. p. 28-31.
• Bandodkar AJ, Wang J. Non-invasive wearable electrochemical sensors: a review. Trends Biotechnol. 2014 Jul;32(7):363-71. doi: 10.1016/j.tibtech.2014.04.005. Epub 2014 May 19. PMID 24853270
• Windmiller JR, Wang J. Wearable electrochemical sensors and biosensors: a review.: Electroanalysis; 2013. p. 29-46.
• Longardner K, Liu C, Momper J, Mahato K, Moonla C, Ghodsi H, Wang J, Litvan I. Acute Pharmacodynamic Effects of Oral Levodopa on Blood Pressure in Parkinson's Disease. Pharmacotherapy. 2025 Nov;45(11):721-728. doi: 10.1002/phar.70066. Epub 2025 Oct 1. PMID 41031701

Идентификаторы

NCT: NCT04735627 · 201535

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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