A single-center open-label, randomized, parallel-group controlled clinical trial on the long-term effect of the treatment with EGb 761 in blood markers of inflammation and neurodegeneration in patients with mild cognitive impairment: ACE-2020-EGb 761

Background Neuroinflammation plays a central role in Alzheimer's disease (AD) pathology and other dementias. EGb 761, a standardized Ginkgo biloba extract, has shown potential anti-inflammatory and neuroprotective properties. Objective This study evaluated the effects of EGb 761 on plasma proteins related to inflammation and neurodegeneration, cognitive performance, and core AD biomarkers in individuals with mild cognitive impairment (MCI). Methods We conducted a 12-month randomized, controlled, open-label clinical trial with a 12-month extension phase in 100 patients with MCI recruited at a single center. During the first 12 months, participants were randomly assigned to EGb 761 or no treatment. In the extension phase, all participants received EGb 761 for an additional 12 months. Plasma samples were collected at baseline and at 6-month intervals throughout both phases. Inflammatory and neurological proteomic profiles were assessed using the Olink Inflammation and Neurology panels. AD biomarkers including Aβ 40 , Aβ 42 , Aβ 42/40 ratio, GFAP, NfL, and pTau231 were measured in plasma. Clinical, neurological, and neuropsychological assessments were performed at each visit. Results EGb 761 was associated with nominally significant longitudinal decreases in 15 plasma proteins linked to innate immunity and axon guidance, replicated in the delayed-start group. Conclusions EGb 761 exposure is associated with longitudinal modulation of serum markers associated with systemic inflammation and neurodegeneration in MCI. Larger placebo-controlled biomarker-driven trials are warranted to confirm whether this translates into clinically meaningful neuroprotection. Trial registration: Registro Español de estudios clínicos (REec) 2020-003776-41, ClinicalTrials.gov NCT05594355, https://clinicaltrials.gov/study/NCT05594355

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Journal
Journal of Alzheimer s Disease
Published
2026-09-29
DOI
https://doi.org/10.1177/13872877261490130
Primary Topic
Ginkgo biloba and Cashew Applications
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article
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article

A single-center open-label, randomized, parallel-group controlled clinical trial on the long-term effect of the treatment with EGb 761 in blood markers of inflammation and neurodegeneration in patients with mild cognitive impairment: ACE-2020-EGb 761

Liliana Vargas, Emilio Alarcón‐Martín, Sara Jofresa, Hanna Huber et al.
Journal of Alzheimer s Disease
Ginkgo biloba and Cashew Applications
article

A single-center open-label, randomized, parallel-group controlled clinical trial on the long-term effect of the treatment with EGb 761 in blood markers of inflammation and neurodegeneration in patients with mild cognitive impairment: ACE-2020-EGb 761

Liliana Vargas, Emilio Alarcón‐Martín, Sara Jofresa, Hanna Huber, Marta Marquié, Agustı́n Ruiz, Gemma Ortega, Marta Ibarria, Laura Montrreal, Itziar de Rojas, Adelina Orellana, Maitée Rosende‐Roca, Santos Mañes, Yahveth Cantero‐Fortiz, Amanda C. Cano, Raúl Núñez‐Llaves, Merçé Boada, Alba Pérez‐Cordón, Montserrat Alegret, Xavier Morató, Laia Montoliu‐Gaya, Ángela Sanabria, Ana Pancho, María Eugenia Sáez, Rosario Cuevas, Juan Pablo Tartari, Lluís Tárraga, Asunción Lafuente, Sergi Valero, Laia Cañada, Miren Gurruchaga, Núria Aguilera, Mar Buendía, Pilar Sanz-Cartagena, Susana Diego, Marta Martinez-Lucas, Henrik Zetterberg, Ana Espinosa
article en

Abstract

Background Neuroinflammation plays a central role in Alzheimer's disease (AD) pathology and other dementias. EGb 761, a standardized Ginkgo biloba extract, has shown potential anti-inflammatory and neuroprotective properties. Objective This study evaluated the effects of EGb 761 on plasma proteins related to inflammation and neurodegeneration, cognitive performance, and core AD biomarkers in individuals with mild cognitive impairment (MCI). Methods We conducted a 12-month randomized, controlled, open-label clinical trial with a 12-month extension phase in 100 patients with MCI recruited at a single center. During the first 12 months, participants were randomly assigned to EGb 761 or no treatment. In the extension phase, all participants received EGb 761 for an additional 12 months. Plasma samples were collected at baseline and at 6-month intervals throughout both phases. Inflammatory and neurological proteomic profiles were assessed using the Olink Inflammation and Neurology panels. AD biomarkers including Aβ 40 , Aβ 42 , Aβ 42/40 ratio, GFAP, NfL, and pTau231 were measured in plasma. Clinical, neurological, and neuropsychological assessments were performed at each visit. Results EGb 761 was associated with nominally significant longitudinal decreases in 15 plasma proteins linked to innate immunity and axon guidance, replicated in the delayed-start group. Conclusions EGb 761 exposure is associated with longitudinal modulation of serum markers associated with systemic inflammation and neurodegeneration in MCI. Larger placebo-controlled biomarker-driven trials are warranted to confirm whether this translates into clinically meaningful neuroprotection. Trial registration: Registro Español de estudios clínicos (REec) 2020-003776-41, ClinicalTrials.gov NCT05594355, https://clinicaltrials.gov/study/NCT05594355

Journal of Alzheimer s Disease
The University of Texas at San Antonio Health Science Center (US), Instituto de Salud Carlos III (ES), Universitat Internacional de Catalunya (ES), Biomedical Research Networking Center on Neurodegenerative Diseases (ES), Centro Nacional de Biotecnología (ES), University of Gothenburg (SE)
Good health and well-being
Openalex Percentile: Top 7%
Ginkgo biloba and Cashew Applications
DOISourceOpenAlex
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