Estudio clínico de fase 2, multicéntrico, aleatorizado, doble ciego,controlado con placebo, de grupos paralelos, prospectivo y de 52 semanas de duración para evaluar la seguridad y la eficacia de GV1001 administrado por vía subcutánea para el tratamiento de la enfermedad de Alzheimer leve a moderada.

Dades bàsiques

Protocol:
GV1001-AD-CL2-007
EURDRACT:
2021-004809-40
NCT:
Centre:
HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
Any inici:
2023
Any de finalització:
ENSAYO CLÍNICO

Documents

  • No hi ha documents

Participants

Grups d'Investigació

Finançadors - Promotors

GEMVAX & KAEL CO., LTD

Resultats de l'Assaig Clínic


[[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

  • Open Access.

[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

  • Open Access.

[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

  • Open Access.

[Translated article] New challenges in advanced therapies.

Megías-Vericat JE; (...); Poveda Andrés JL

Article. 10.1016/j.farma.2024.05.001. 2024

  • Open Access.

[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

  • Open Access.

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

  • Open Access.

Accuracy and prognostic impact of FDG PET/CT and biopsyin bone marrow assessment of follicular lymphomaat diagnosis: A Nation-Wide cohort study.

Rodenas-Quinonero, Isabel; (...); Ortuno, Francisco Jose

Article. 10.1002/cam4.5424. 2022

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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


Associations between antidiabetic medications and cerebrospinal fluid biomarkers of Alzheimer's disease.

Garcia-Lluch, Gemma; (...); Chafer-Pericas, Consuelo

Article. 10.1177/13872877241304995. 2024

  • Open Access.

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


CART-AI-Radiomics: Survival and Neurotoxicity Prediction in B-Cell Lymphoma Patients Treated with CAR-T Cells through an Imaging Features-Based Model

Ferrer Lores, Blanca; (...); Jose Terol, Maria

Meeting Abstract. 10.1182/blood-2023-185088. 2023


Cavernous Sinus Thrombosis Secondary to Streptococcus Constellatus Pharynges

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

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

  • Open Access.

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


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

  • Open Access.

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

  • Open Access.

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


COST-EFFECTIVENESS ANALYSIS OF DIFELIKEFALIN FOR THE TREATMENT OF CHRONIC KIDNEY DISEASE ASSOCIATED-PRURITUS IN SPAIN

Sanchez-Alvarez, Emilio E.; (...); Hernaez Colque, M.

Meeting Abstract. 2024


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

  • Open Access.

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

  • Open Access.

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

  • Open Access.

Discordant Amyloid Status Diagnosis in Alzheimer's Disease.

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

Article. 10.3390/biomedicines10112880. 2022

  • Open Access.

Early Alzheimer's Disease Screening Approach Using Plasma Biomarkers

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

Article. 10.3390/ijms241814151. 2023

  • Open Access.

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

  • Open Access.

Fast Declining Prediction in Alzheimer's Disease from Early Clinical Assessment.

Álvarez-Sánchez L; (...); Pericás CC

Article. 10.2174/011570159X332930240925095423. 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

  • Open Access.

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

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

Article. 10.3390/ijms25073717. 2024

  • Open Access.

How can artificial intelligence optimize value-based contracting?

Poveda, Jose Luis; (...); Medrano, Ignacio H.

Letter. 10.1186/s40545-022-00475-3. 2022

  • Open Access.

Insights from a 7-Year Dementia Cohort (VALCODIS): ApoE Genotype Evaluation.

Baquero, Miguel; (...); Chafer-Pericas, Consuelo

Article. 10.3390/jcm13164735. 2024

  • Open Access.

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

  • Open Access.

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

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

Article. 10.3390/antibiotics13080706. 2024

  • Open Access.

Management of iodine contrast induced salivary gland swelling (sialadenitis): experiences from an observational study.

Saro-Buendía M; (...); Armengot Carceller M

Article. 10.1080/00016489.2022.2162121. 2023


Medical help-seeking intentions among patients with early Alzheimer's disease

Villarejo-Galende, Alberto; (...); Maurino, Jorge

Article. 10.3389/fpsyt.2023.1290002. 2023

  • Open Access.

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

  • Open Access.

National Survey on the Use of Mobile Applications in Patients with Hemophilia and Other Coagulopathies

Eduardo Megias, Juan; (...); Poveda Andres, Jose Luis

Meeting Abstract. 10.1182/blood-2022-169938. 2022

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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

  • Open Access.

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

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

Review. 10.3390/biology12091159. 2023

  • Open Access.

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

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

Meeting Abstract. 2024


Pharmacogenetics in Response to Biological Agents in Inflammatory Bowel Disease: A Systematic Review.

Ballesta-Lopez, Octavio; (...); Poveda-Andres, Jose Luis

Article. 10.3390/ijms26041760. 2025

  • Open Access.

Predicting survival, neurotoxicity and response in B-cell lymphoma patients treated with CAR-T therapy using an imaging features-based model

Ferrer-Lores, Blanca; (...); Alberich-Bayarri, Angel

Article. 10.1186/s13550-024-01172-9. 2024

  • Open Access.

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

  • Open Access.

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


Prognostic value of genetic alterations and (18)F-FDG PET/CT imaging features in diffuse large B cell lymphoma.

Ferrer-Lores B; (...); Terol MJ

Article. 10.2156/6976/ajcr0146852. 2023

  • Open Access.

Prognostic value of genetic alterations and 18F-FDG PET/CT imaging features in diffuse large B cell lymphoma

Ferrer-Lores, Blanca; (...); Terol, Maria Jose

Article. 10.2156/6976/ajcr0146852. 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

  • Open Access.

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

  • Open Access.

State of the art and future perspectives of new radionuclides in Nuclear Medicine.

Rosales, J J; (...); Quincoces, G

Article. 10.1016/j.remnie.2025.500082. 2025


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

  • Open Access.

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

  • Open Access.

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