Device-aided therapies (DATs) in Parkinson’s disease (PD). The DATs-PD GETM Spanish Registry Protocol Study

ABSTRACT Background and objective Device-aided therapies (DATs) are treatments indicated for people with Parkinsońs disease (PwP) with clinical fluctuations that are not optimally controlled with conventional medication. New DATs have recently emerged such as levodopa-entacapone-carbidopa intestinal gel infusion (LECIG) and subcutaneous infusion of foslevodopa/foscarbidopa (fLD/fCD). It is necessary to know the differences between different DATs. Patients and Methods We present here the protocol study of the DATs-PD GETM Spanish Registry. This is a descriptive, observational, prospective, multicenter, open study that is proposed as a clinical registry with progressive inclusion of PwP treated with a DAT in daily clinical practice conditions in more 40 centers from Spain for 10 years. The principal aim is to know the type of DAT that PwP in our country (Spain) receive. Specific objectives are to compare the clinical characteristics of the patients, the effectiveness, safety and tolerability, to identify predictors of a good response and to analyze the response by groups (gender, disease duration, phenotype, etc.). There is a baseline visit (V1; indication of the therapy), start visit (V2; initiation of the therapy) and follow-up visits at 6 months ± 3 months (V3_6M) and after this annually ± 3 months (V3_12M, V3_24M, etc.). Results The registry is on-going. The first patient was included on Abril 10, 2024. Patient recruitment and follow-up will be conducted until 31/DEC/2033. The estimate is to reach a minimum sample size of at least 3,000 patients. Conclusion The present study will help improve the care of PD patients treated with a DAT. Authors’ Roles Santos-García D: conception, organization, and execution of the project; funding acquisition; supervision; writing of the first draft of the manuscript; recruitment and/or evaluation of participants; entering data into the database. González-Ortega G: preparation and development of the database; registration of participants in the platform; recruitment and/or evaluation of participants; entering data into the database; review and critique. Sánchez Alonso P: recruitment and/or evaluation of participants; entering data into the database; review and critique. Planas-Ballvé A: recruitment and/or evaluation of participants; entering data into the database; review and critique. García Ramos R: recruitment and/or evaluation of participants; entering data into the database; review and critique. Cabo López I: recruitment and/or evaluation of participants; entering data into the database; review and critique. Blázquez Estrada M: recruitment and/or evaluation of participants; entering data into the database; review and critique. Sánchez Ferro A: collaboration in the coordination of the project as coordinator of GETM; recruitment and/or evaluation of participants; entering data into the database; review and critique. Financial Disclosures for the previous 12 months Santos-García D. has received honoraria for educational presentations and advice service by Abbvie, UCB Pharma, Lundbeck, KRKA, Zambon, Bial, Italfarmaco, Teva, Archímedes, Esteve, Stada, Merz, and grants from the “Fundación Professor Novoa Santos” as a result of the “CONVOCATORIA DE AYUDAS PARA LA REALIZACIÓN DE PROYECTOS DE INVESTIGACIÓN PARA GRUPOS EMERGENTES Y ASOCIADOS DEL INIBIC (2023/2024)”. González-Ortega G. has received honoraria for educational purposes from ABBIE, Zambon, Bial, Esteve and Italfarmaco Sánchez Alonso P. has received honoraria for educational presentations and advice service by Abbvie, UCB Pharma, Lundbeck, KRKA, Zambon, Bial, and Teva. Planas-Ballvé A:None. García Ramos R. has received honoraria and grants for lecturing, advisory services from Abbvie, Zambón, Bial, Merk, Stada. Cabo López I. has received honoraria for educational presentations and advice service by Abbvie, Zambon, Bial, Orion, Italfarmaco and Esteve. Blázquez Estrada M. has received honoraria for educational presentations by Dysport, Esteve, Bial, Italfármaco, Boston Sc. and Stada and for advice service by Esteve, Bial, Suazio. Sánchez Ferro A. has received: grants or contracts from ERA-NET Horizon 2020 program JPCOFUND2 (reference number HESOCARE-329-073), MDS (eDiary project), Instituto de Salud Carlos III (reference number P122/01177); consulting fees from Abbvie, Esteve, Orion Pharma, and Prim; and payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Abbvie, Bayer, Esteve, MDS Society, EAN, Novartis, Monitor, Organon, Roche, SEN, Stada, Teva, and Zambon.