Subclinical affective and cognitive fluctuations in Parkinson's disease: a randomized double-blind double-dummy study of
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ORIGINAL COMMUNICATION
Subclinical affective and cognitive fluctuations in Parkinson’s disease: a randomized double‑blind double‑dummy study of Oral vs. Intrajejunal Levodopa Jaime Kulisevsky1,2 · Helena Bejr‑Kasem1,2 · Saul Martinez‑Horta1,2 · Andrea Horta‑Barba1,2 · Berta Pascual‑Sedano1,2,3 · Antonia Campolongo1,2,3 · Juan Marín‑Lahoz1,2 · Ignacio Aracil‑Bolaños1,2 · Jesús Pérez‑Pérez1,2 · Cristina Izquierdo‑Barrionuevo1,2 · Oriol de Fàbregues4 · Victor Puente5 · Ane Crespo‑Cuevas6 · Matilde Calopa7 · Javier Pagonabarraga1,2 Received: 12 February 2020 / Revised: 24 May 2020 / Accepted: 18 June 2020 © Springer-Verlag GmbH Germany, part of Springer Nature 2020
Abstract Background Chronic levodopa treatment in Parkinson’s disease (PD) may promote undesirable motor and non-motor fluctuations. Compared to chronic oral levodopa treatment, continuous infusion of levodopa/carbidopa intestinal gel (LCIG) in advanced PD reduces motor fluctuations. However, differences in their effect on acute non-motor changes were not formally demonstrated. Objective We performed a randomized, double-blind, double-dummy, crossover study to compare acute non-motor changes between intermittent oral immediate-release carbidopa/levodopa (LC-IR) and LCIG. Methods After > 12-h OFF, thirteen PD patients chronically treated with LCIG and without history of non-motor swings, were allocated to receive first, LCIG infusion plus three oral doses of placebo, or placebo infusion plus three oral doses of LC-IR. Over-encapsulated oral medication (LC-IR or placebo) was administered every 2 h. We monitored plasmatic levels of levodopa, motor status (UPDRS-III), mood, anxiety, and frontal functions at baseline (0-h) and hourly after each oral challenge. Results Repeated-measures ANOVAs showed significant group by treatment interaction indicating more fluctuations of levodopa plasma levels with LC-IR. No significant interactions were seen in the temporal profile of motor status, anxiety, mood and cognition. However, point-to-point parametric and nonparametric tests showed a significant more marked and more sustained improvement in anxiety scores under LCIG. A significant improvement of mood and verbal fluency was seen a + 3-h only under LCIG. Discussion Our sample of advanced PD patients exhibited moderate but significant non-motor fluctuations. LCIG was associated with a more favorable profile of acute affective and cognitive fluctuations that was particularly expressed at the first part of the infusion curve. Keywords Parkinson’s disease · Levodopa/carbidopa intestinal gel · Pharmacokinetics · Non-motor fluctuations · Mood · Anxiety · Executive function * Jaime Kulisevsky [email protected] 1
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Movement Disorders Unit, Neurology Department, Hospital de la Santa Creu i Sant Pau, Mas Casanovas 90, 08041 Barcelona, Spain Institut d’Investigacions Biomèdiques Sant Pau (IIB‑Sant Pau), Centro de Investigación en Red Enfermedades Neurodegenerativas (CIBERNED), Universitat Autònoma de Barcelona (UAB), Barcelona, Spain Faculty of Healt
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