Portal de investigación
Estudio en fase IIIb/IV, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos para verificar el beneficio clínico de aducanumab (BIIB037) en participantes con enfermedad de Alzheimer.
Datos básicos
- Código:
- 221AD305
- Protocolo:
- 221AD305
- EUDRACT:
- 2022-001671-14
- NCT:
- Centro:
- HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
- Dotación:
- Año de incio:
- 2023
- Año de finalización:
- 2024
Objetivos del proyecto
Objetivo Principal: Verificar el beneficio clínico de dosis mensuales de aducanumab en la ralentización del deterioro cognitivo y funcional, según lo determinado por los cambios en la puntuación CDR-SB en comparación con placebo en participantes con enfermedad de Alzheimer temprana. Objetivos Secundarios: Objetivos secundarios clave: Evaluar el efecto de las dosis mensuales de aducanumab en comparación con placebo en el deterioro clínico según lo determinado mediante la escala iADRS. Evaluar el efecto de las dosis mensuales de aducanumab en comparación con placebo en el deterioro clínico según lo determinado mediante el cuestionario ADCS-ADL-MCI. Evaluar el efecto de las dosis mensuales de aducanumab en comparación con placebo en el deterioro clínico según lo determinado mediante la escala ADAS-Cog13. Evaluar el efecto de las dosis mensuales de aducanumab en comparación con placebo en el deterioro clínico según lo determinado mediante el examen MMSE. Evaluar el efecto de las dosis mensuales de aducanumab en comparación con placebo en el deterioro clínico según lo determinado mediante el inventario NPI-10.
Documentos
- No hay documentos
Grupos
Financiadores - Promotores
Resultados del Ensayo Clínico
[[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] Cybersecurity: a priority for pharmacy services in the age of artificial intelligence
Marin, Cayetano M. Hernandez, Monte-Boquet, Emilio, Andres, Jose Luis Poveda
Editorial Material. 10.1016/j.farma.2024.08.009. 2024
[Translated article] Good humanisation practices in the healthcare of patients with rare diseases in Pharmacy Services
Company Albir MJ, Andrés JLP, Solsona MDE
Article. 10.1016/j.farma.2023.10.004. 2024
[Translated article] New challenges in advanced therapies.
Megías-Vericat JE; (...); Poveda Andrés JL
Article. 10.1016/j.farma.2024.05.001. 2024
[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
Amyloid brain-dedicated PET images can diagnose Alzheimer's pathology with Centiloid Scale.
Gandia-Ferrero MT; (...); Martí-Bonmatí L
Article. 10.1016/j.ejmp.2024.103345. 2024
Angiotensin II Receptor Blockers Reduce Tau/ASS42 Ratio: A Cerebrospinal Fluid Biomarkers' Case-Control Study.
Garcia-Lluch, Gemma; (...); Chafer-Pericas, Consuelo
Article. 10.3390/pharmaceutics15030924. 2023
Assessing the value of moderate-to-severe atopic dermatitis treatment using multi-criteria decision analysis (MCDA).
Pereyra-Rodríguez JJ; (...); Ortiz de Frutos FJ
Letter. 10.1111/jdv.19432. 2023
Assessment of COVID-19 lockdown effect on early Alzheimer Disease progression.
Pena-Bautista, Carmen; (...); Chafer-Pericas, Consuelo
Article. 10.1007/s00415-023-11899-5. 2023
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
Attitudes toward seeking professional help among patients with early Alzheimer's disease
Villarejo-Galende, A.; (...); Maurino, J.
Meeting Abstract. 2023
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
Clinical experience of whole body and tumour dosimetry of 131-I-mIBG treatment for pediatric patients
Espallardo, I. Torres; (...); Prado-Wohlwend, S.
Meeting Abstract. 2023
Clinical usefulness of cerebrospinal fluid biomarkers in Alzheimer Disease.
Pena-Bautista, Carmen; (...); Chafer-Pericas, Consuelo
Article. 10.1111/eci.13910. 2022
ComBat harmonization in different PET imaging scenarios
Gandia-Ferrero, M.; (...); Marti-Bonmati, L.
Meeting Abstract. 2023
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
Cybersecurity, a priority for pharmacy services in the age of artificial intelligence.
Hernández Marín CM, Monte-Boquet E, Poveda Andrés JL
Editorial Material. 10.1016/j.farma.2024.08.001. 2024
Defining Alzheimer's Disease through Proteomic CSF Profiling.
Pena-Bautista, Carmen; (...); Chafer-Pericas, Consuelo
Article. 10.1021/acs.jproteome.4c00590. 2024
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
Early Alzheimer's Disease Screening Approach Using Plasma Biomarkers
Alvarez-Sanchez, Lourdes; (...); Chafer-Pericas, Consuelo
Article. 10.3390/ijms241814151. 2023
Emotion recognition and baseline cortisol levels relationship in early Alzheimer Disease.
Ferrer-Cairols, I.; (...); Chafer-Pericas, C.
Article. 10.1016/j.biopsycho.2023.108511. 2023
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
How can artificial intelligence optimize value-based contracting?
Poveda, Jose Luis; (...); Medrano, Ignacio H.
Letter. 10.1186/s40545-022-00475-3. 2022
Insights from a 7-Year Dementia Cohort (VALCODIS): ApoE Genotype Evaluation.
Baquero, Miguel; (...); Chafer-Pericas, Consuelo
Article. 10.3390/jcm13164735. 2024
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
Medical help-seeking intentions among patients with early Alzheimer's disease
Villarejo-Galende, Alberto; (...); Maurino, Jorge
Article. 10.3389/fpsyt.2023.1290002. 2023
Misfolded alpha-synuclein detection by RT-QuIC in dementia with lewy bodies: a systematic review and meta-analysis.
Peña-Bautista C; (...); Ferreira D
Article. 10.3389/fmolb.2023.1193458. 2023
New approach for early and specific Alzheimer disease diagnosis from different plasma biomarkers.
Forte, Anabel; (...); Chafer-Pericas, Consuelo
Article. 10.1016/j.cca.2024.117842. 2024
New challenges of advanced therapies.
Megías-Vericat JE; (...); Poveda Andrés JL
Article. 10.1016/j.farma.2023.11.008. 2024
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
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
Prognostic value of cerebrospinal fluid biomarkers in mild cognitive impairment due to Alzheimer disease.
Lopez-Cuevas, R; (...); Chafer-Pericas, C
Article. 10.1016/j.nrleng.2020.07.024. 2023
Relationship between neuroimaging and emotion recognition in Mild Cognitive Impairment patients.
Gandia-Ferrero, Maria Teresa; (...); Marti-Bonmati, Luis
Article. 10.1016/j.bbr.2023.114844. 2024
Relationship between Plasma Lipid Profile and Cognitive Status in Early Alzheimer Disease.
Pena-Bautista, Carmen; (...); Chafer-Pericas, Consuelo
Article. 10.3390/ijms25105317. 2024
Sequential treatment of High-risk Neuroblastoma combining I-131 MIBG high-dose and Topotecan. First experience
Orrego, N.; (...); Bello-Arques, P.
Meeting Abstract. 2023
Spinocerebellar Ataxia 36 is a Frequent Cause of Hereditary Ataxia in Eastern Spain
Baviera-Munoz, Raquel; (...); Bataller, Luis
Article. 10.1002/mdc3.13740. 2023
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