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Proyectos y Estudios
Estudio comparativo con placebo, con enmascaramiento para pacientes e investigadores, para evaluar la eficacia, la seguridad y la tolerabilidad de bepranemab (UCB0107) en los participantes del estudio con enfermedad de Alzheimer (EA) de prodrómica a leve, seguido de un periodo de prolongación sin enmascaramiento.

Estudio comparativo con placebo, con enmascaramiento para pacientes e investigadores, para evaluar la eficacia, la seguridad y la tolerabilidad de bepranemab (UCB0107) en los participantes del estudio con enfermedad de Alzheimer (EA) de prodrómica a leve, seguido de un periodo de prolongación sin enmascaramiento.

Datos básicos

Protocolo:: AH0003
EUDRACT:: 2020-005829-88
NCT:
Centro:: HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
Año de incio:: 2021
Año de finalización:: 2025

ENSAYO CLÍNICO

Objetivos del proyecto

Objetivo Principal: - Investigación de los efectos de bepranemab en comparación con un placebo sobre la suma de las casillas de la escala de clasificación clínica de la demencia (CDR-SB) hasta la semana 80 en los participantes del estudio con enfermedad de Alzheimer (EA) leve o prodrómica Objetivos Secundarios: - Evaluación de la seguridad y la tolerabilidad de bepranemab en comparación con un placebo durante 80 semanas en los participantes del estudio con enfermedad de Alzheimer (EA) leve o prodrómica - Investigación del efecto de bepranemab en la carga de proteína t en el cerebro, medida por tomografía por emisión de positrones (TEP) con la sonda 1 de t de Genentech [18F] (GTP1) en participantes del estudio con EA leve o prodrómica - Investigación de los efectos de bepranemab en comparación con un placebo sobre las mediciones cognitivas y funcionales a lo largo del tiempo en los participantes del estudio con EA leve o prodrómica - Caracterización de la farmacocinética (FC) de bepranemab tras la administración intravenosa (i.v.) repetida a los participantes del estudio con EA leve o prodrómica

Documentos

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Participantes

Irene Torres Espallardo

Investigador Colaborador
Beatriz Muria Romero

Data Manager / Study Coordinator
Consuelo Olivas Arroyo

Investigador Colaborador
José Luis Poveda Andrés

Investigador Colaborador
Lorena García Vallés

Investigador Colaborador
Miguel Baquero Toledo

Investigador Principal
Inés Ferrer Cairols

Investigador Colaborador
Maria Perez Fernandez

Técnico Apoyo Investigación
Joan Octavi Carreres Polo

Investigador Colaborador
Luis Raga Rodríguez

Investigador Colaborador
Aitana Prieto Cagigal

Data Manager / Study Coordinator
Begoña Martinez Sanchis

Investigador Colaborador
David Barbas Galindo

Investigador Colaborador
Lourdes Álvarez Sánchez

Investigador Colaborador
Sonia Gines Cardenas

Investigador Colaborador
Africa Almendros Riaza

Investigador Colaborador
Fatima Tomas Medina

Investigador Colaborador
Oussama Bardouz Gouguasse

Investigador Colaborador
Silvia Maestro Huguet

Investigador Colaborador
Inés Jareño Toboso

Data Manager / Study Coordinator
Maria Del Mar San Juan Tubilleja

Investigador Colaborador
Laura Ferré González

Data Manager / Study Coordinator
Mar Pereto Pamblanco

Investigador Colaborador
Laura Fernandez Romero

Investigador Colaborador
Sara Ballesta Martínez

Investigador Colaborador

Ver todos los Investigadores

Grupos

Farmacogenética

Investigador Principal

María José Herrero Cervera
Investigacion Biomédica en Imagen (GIBI 2-30)

Investigador Principal

Leonor Cerdá Alberich
Núcleo de investigación traslacional integrado Urológico de Valencia (NITIUV)

Leader

César David Vera Donoso
Unidad de Descubrimiento de Fármacos (UDF)

Investigador Principal

Leonor Puchades Carrasco
Investigación en Neuroinmunología y Esclerosis Múltiple

Leader

Bonaventura Casanova Estruch
Grupo de Investigación en Enfermedad de Alzheimer (GINEA)

Investigador Principal

Miguel Baquero Toledo
Grupo de Investigación de Farmacia

Investigador Principal

Javier García Pellicer

Financiadores - Promotores

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Resultados del Ensayo Clínico

Publicaciones en Revistas 109

[[Tranaslated article]]Primary Cutaneous Lymphoma Registry of the Spanish Academy of Dermatology and Venereology (AEDV): Data for the First 5 Years.

López DF; (...); Ortiz-Romero, P. L.

Article. 10.1016/j.ad.2022.11.013. 2023

[Translated article] Pharmacokinetic-guided switching from standard half-life factor VIII to extended half-life pegylated factor VIII in haemophilia A therapy in clinical practice.

Chovi-Trull, Maria; (...); Andres, Jose Luis Poveda

Article. 10.1016/j.farma.2024.12.007. 2025

[Translated article] Real-world effectiveness and safety of nivolumab in patients with relapsed or refractory classical Hodgkin lymphoma.

Fernandez, Laura Lorente; (...); Andres, Jose Luis Poveda

Article. 10.1016/j.farma.2024.09.006. 2024

A Gadolinium(III) Complex Based on Pyridoxine Molecule with Single-Ion Magnet and Magnetic Resonance Imaging Properties.

Orts-Arroyo, Marta; (...); Martinez-Lillo, Jose

Article. 10.3390/ijms25042112. 2024

A multicriteria decision analysis (MCDA) applied to three long-term prophylactic treatments for hereditary angioedema in Spain

Zozaya, Neboa; (...); Hidalgo-Vega, Alvaro

Article. 10.33393/grhta.2022.2333. 2022

Assessment of Plasma and Cerebrospinal Fluid Biomarkers in Different Stages of Alzheimer's Disease and Frontotemporal Dementia.

Álvarez-Sánchez L; (...); Cháfer-Pericás C

Article. 10.3390/ijms24021226. 2023

Bioavailability of once-daily tacrolimus formulations used in clinical practice in the management of De Novo kidney transplant recipients: the better study.

Fernandez Rivera C; (...); Hernandez D

Article. 10.1111/ctr.14550. 2022

Brain areas lipidomics in female transgenic mouse model of Alzheimer's disease

Ferre-Gonzalez, Laura; (...); Chafer-Pericas, Consuelo

Article. 10.1038/s41598-024-51463-3. 2024

Cardiovascular Risk Scales Association with Cerebrospinal Fluid Alzheimer's Disease Biomarkers in Cardiovascular Low Cardiovascular Risk Regions.

García-Lluch G; (...); Cháfer-Pericás C

Article. 10.14283/jpad.2024.16. 2024

Cavernous Sinus Thrombosis Secondary to Streptococcus Constellatus Pharynges

Jaramillo-Angel, Natalia; (...); Carceller, Miguel Armengot

Article. 10.1007/s12070-024-04511-3. 2024

Clinical benefits of a Bayesian model for plasma-derived factor VIII/VWF after one year of pharmacokinetic-guided prophylaxis in severe/moderate hemophilia A patients

Megias-Vericat, JE; (...); Poveda, JL

Article. 10.1016/j.thromres.2021.07.009. 2021

Comparison of protocols with respiratory-gated (4D) motion compensation in PET/CT: open-source package for quantification of phantom image quality.

Martinez-Movilla, Andrea; (...); Carles, Montserrat

Article. 10.1186/s40658-022-00509-4. 2022

Consensus recommendations for the improvement of inter- and intra-centre care coordination in the management of hemophilia.

Montoro-Ronsano JB; (...); Soto-Ortega I

Article. 10.1016/j.farma.2023.01.003. 2023

Consensus recommendations for the improvement of inter- and intra-centre care coordination in the management of hemophilia.

Montoro-Ronsano, Jose Bruno; (...); Soto-Ortega, Inmaculada

Article. 10.1016/j.farma.2023.04.002. 2023

Design and rationale for a real-world prospective, multicenter registry of myocardial revascularization failure and secondary revascularization: The REVASEC study.

Salinas P; (...); Escaned J

Article. 10.1016/j.carrev.2021.11.015. 2021

Determining value in the treatment of activated PI3Kdelta syndrome in Spain: a multicriteria decision analysis from the perspective of key stakeholders.

Abad, Maria Reyes; (...); Gil, Alicia

Article. 10.33393/grhta.2024.3041. 2024

Determining what represents value in the treatment of prurigo nodularis and its key unmet needs in Spain through Multi-Criteria Decision Analysis

Silvestre, Juan Francisco; (...); Serra-Baldrich, Esther

Article. 10.1002/jvc2.275. 2024

Discordant Amyloid Status Diagnosis in Alzheimer's Disease.

García-Vallés L; (...); Cháfer-Pericás C

Article. 10.3390/biomedicines10112880. 2022

Early Alzheimer's Disease Screening Approach Using Plasma Biomarkers

Alvarez-Sanchez, Lourdes; (...); Chafer-Pericas, Consuelo

Article. 10.3390/ijms241814151. 2023

Effectiveness of Caplacizumab Nanobody in Acquired Thrombotic Thrombocytopenic Purpura Refractory to Conventional Treatment

Palanques-Pastor T; (...); Poveda Andrés JL

Article. 10.1159/000517813. 2021

Elevation of serum neurofilament light-chain levels disclose possible occult progressive multifocal leukoencephalopathy and immune reconstitution syndrome in a patient receiving ozanimod: a case report.

Quintanilla-Bordás C; (...); Pérez-Miralles FC

Case Reports. 10.3389/fimmu.2024.1465678. 2024

Free automatic software for quality assurance of computed tomography calibration, edges and radiomics metrics reproducibility.

Saborido-Moral, Juan D.; (...); Carles, Montserrat

Article. 10.1016/j.ejmp.2023.103153. 2023

Genetic Variants Associated with Biological Treatment Response in Inflammatory Bowel Disease: A Systematic Review.

Plaza J; (...); Moret-Tatay I

Article. 10.3390/ijms25073717. 2024

Guide to Good Humanization Practices in Patients with Rare Diseases. who vadis

Poveda Andres, Jose Luis

Editorial Material. 2022

Healthcare Resource Utilization among Patients between 60-75 Years with Secondary Acute Myeloid Leukemia Receiving Intensive Chemotherapy Induction: A Spanish Retrospective Observational Study

Solana-Altabella, Antonio; (...); Martinez-Cuadron, David

Article. 10.3390/cancers14081921. 2022

Is erenumab an efficient alternative for the prevention of episodic and chronic migraine in Spain? Results of a cost-effectiveness analysis.

Pozo-Rosich P; (...); Irimia P

Article. 10.1186/s10194-024-01747-w. 2024

Isavuconazole Pharmacokinetics in Critically Ill Patients: Relationship with Clinical Effectiveness and Patient Safety.

Martin-Cerezuela, Maria; (...); Ramirez Galleymore, Paula

Article. 10.3390/antibiotics13080706. 2024

Lipids as early and minimally invasive biomarkers for Alzheimer disease.

Casas-Fernandez, Esther; (...); Chafer-Pericas, Consuelo

Article. 10.2174/1570159X19666211102150955. 2021

Manipulación de fármacos para su administración por gastrostomía endoscópica percutánea en pacientes con esclerosis lateral amiotrófica y nutrición enteral.

Vázquez Polo A; (...); Vázquez Costa JF

Article. 10.20960/nh.03946. 2022

Matching-Adjusted Indirect Comparison of Efficacy and Consumption of rVIII-SingleChain Versus Two Recombinant FVIII Products Used for Prophylactic Treatment of Adults/Adolescents with Severe Haemophilia A

Bonanad, S; (...); Santos, S

Article. 10.1007/s12325-021-01853-0. 2021

Multi-Omic Approaches to Breast Cancer Metabolic Phenotyping: Applications in Diagnosis, Prognosis, and the Development of Novel Treatments

Gomez-Cebrian, N; (...); Pineda-Lucena, A

Review. 10.3390/cancers13184544. 2021

Novel Ultrasensitive Detection Technologies for the Identification of Early and Minimally Invasive Alzheimer's Disease Blood Biomarkers.

Alvarez-Sanchez, Lourdes; (...); Chafer-Pericas, Consuelo

Article. 10.3233/JAD-215093. 2022

Objective Image Quality Comparison Between Brain-Dedicated PET and PET/CT Scanners.

Gandia-Ferrero MT; (...); Martí-Bonmatí L

Article. 10.1007/s10916-023-01984-7. 2023

Observational study to evaluate discontinuation of monotherapy with cobicistat-boosted darunavir in patients with human immunodeficiency virus

Solana-Altabella, Antonio; (...); Poveda-Andres, Jose Luis

Article. 10.1097/MD.0000000000032208. 2022

ODs with a positive TPR conclusion, not subject to a conditional approval, and approved without requering a pass would be more likely to be reimbursed in Spain.

Poveda JL; (...); Badia X

Article. 10.1186/s13023-022-02610-4. 2023

Omics-Based Approaches for the Characterization of Pompe Disease Metabolic Phenotypes

Gomez-Cebrian, Nuria; (...); Puchades-Carrasco, Leonor

Review. 10.3390/biology12091159. 2023

Onabotulinum Toxin A (OnA) as a preventive treatment for non-migraine headaches: a retrospective analysis

Nieves Castellanos, C.; (...); Diaz Insa, S.

Meeting Abstract. 2024

OPTIMIZING MANAGEMENT AND OUTCOMES OF ACTIVATED PHOSPHOINOSITIDE 3-KINASE DELTA SYNDROME (APDS) IN SPAIN: BEWAYAPDS PROJECT

Flores-Moreno, S.; (...); Gil, A.

Meeting Abstract. 2024

Paracetamol vs. Ibuprofen in Preterm Infants With Hemodynamically Significant Patent Ductus Arteriosus: A Non-inferiority Randomized Clinical Trial Protocol (vol 8, 372, 2020)

Garcia-Robles, Ana; (...); Aguar Carrascosa, Marta

Correction. 10.3389/fped.2021.834454. 2022

Patient and health practitioner perceptions about the role of hospital pharmacists along the care continuum: the Fharmaconectados Project

Morillo-Verdugo, R; (...); Diaz-Olmo, J

Article. 10.7399/fh.11719. 2021

Patient and health practitioner perceptions about the role of hospital pharmacists along the care continuum: the Fharmaconectados Project.

Morillo-Verdugo R; (...); Díaz-Olmo J

Article. 2021

Plasma lipidomics in early APP/PS1 female mouse model and its relationship with brain: Is it affected by the estrous cycle?

Ferre-Gonzalez, Laura; (...); Chafer-Pericas, Consuelo

Article. 10.1186/s13195-024-01549-x. 2024

Presence of good humanization practices in the healthcare of patients with rare diseases in Pharmacy Services

Company Albir MJ, Poveda Andrés JL, Edo Solsona MD

Article. 10.1016/j.farma.2023.06.0131130. 2024

Primary Cutaneous Lymphoma Registry of the Spanish Academy of Dermatology and Venereology (AEDV): Data for the First 5 Years.

Falkenhain-Lopez, D; (...); Ortiz-Romero, P L

Article. 10.1016/j.ad.2022.11.010. 2023

SMPTall man lettering application in medication information systems as a quality and safety strategy in hospital organization

Iglesias Gomez, Ruben; (...); Poveda Andres, Jose Luis

Article. 10.1111/jcpt.13703. 2022

The value of the reflective discussion in decision-making using multi-criteria decision analysis (MCDA): an example of determining the value contribution of tabelecleucel for the treatment of the Epstein Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD).

Badia, Xavier; (...); Valles, Joan-Antoni

Article. 10.1186/s13023-024-03324-5. 2024

Toxic-metabolic encephalopathy induced by metronidazole and disulfiram: classics never die.

Chovi-Trull, Maria; (...); Poveda-Andres, Jose Luis

Article. 10.1136/ejhpharm-2024-004184. 2024

VALUE CRITERIA FOR OUTCOMES BASED MANAGED ENTRY AGREEMENT OF CAR-T IN RELAPSED OR REFRACTORY MULTIPLE MYELOMA (RRMM) THROUGH MCDA

Poveda, J. L.; (...); Lizan, L.

Meeting Abstract. 2023

Y-90 PET/MR imaging optimization with a Bayesian penalized likelihood reconstruction algorithm.

Calatayud-Jordan, Jose; (...); Torres-Espallardo, Irene

Article. 10.1007/s13246-024-01452-7. 2024