Effect of Treatment With EGb 761(r) on Blood Markers of Inflammation and Oxidative Stress in Patients With MCI

NCT05594355 | Unknown Phase 4

• 1 other identifier: ACE-2020-EGb761
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Mild Cognitive Impairment (MCI) is the moderate impairment of a mental abilities to perform intellectual activities eg memory, calculation, communication... MCI is a disorder that can occur earlier than dementia such as Alzheimer's disease. It is believed that there are several factors involved such as inflammation and oxidative stress which is the production of reactive oxygen species that damage cells. This clinical study tries to evaluate that a treatment already approved by the AEMPS, EGb 761® (Tebofortan), could reduce the levels of markers of inflammation and oxidation in the blood.

Conditions

Mild Cognitive Impairment (MCI)

Outcome Measures

Primary Outcomes (1)

• Compare changes in blood marker levels of inflammation and oxidation

  To compare the changes in the levels of blood markers of inflammation and oxidation between the baseline visit and the follow-up visits at 6 and 12 months between the study group (patients with mild cognitive impairment who receive treatment with 1 daily tablet of EGb 761® 240 mg orally) and the control group (patients with the same clinical characteristics without treatment with EGb 761®). Blood markers of inflammation and oxidation: in v0 (baseline), v1 (6 month), v2 (12 month). The panel of inflammation markers from Olink proteomics (https://www.olink.com/products/inflammation/) will be used with 92 proteins associated with inflammatory diseases and related biological processes. The blood samples of the participants will be collected in the Fundació ACE Nursing Unit and sent to Olink proteomics for further analysis

  Between the baseline visit and follow-up visits at 6 and 12 months. All procedures in each of the visits will be carried out in a maximum period of 30 days.

Secondary Outcomes (3)

• Compare scores on neuropsychiatric tests

  Between baseline visit and follow-up visit at 12 moths and follow-up visit at 24 months. All procedures in each of the visits will be carried out in a maximum period of 30 days.

• Compare changes in cognitive test scores

  Between baseline visit, follow-up visit at 12 moths and follow-up visit at 24 months. All procedures in each of the visits will be carried out in a maximum period of 30 days.

• Obtain data of changes in blood marker levels of inflammation and oxidative stress and security data

  Between v0 (baseline), v1 (6 month), v2 (12 month), v3 (18 month), v4 (24 month) and in the Follow-up visit one month after the end of the treatment. All procedures in each of the visits will be carried out ina maximum period of 30 days.

Study Arms (2)

Arm 1

EXPERIMENTAL

Treatment with EGb 761® (TEBOFORTAN 240 mg) during 24 months.

Drug: TEBOFORTAN

Arm 2

NO INTERVENTION

No Treatment during 12 months and treatment with EGb 761® (TEBOFORTAN 240 mg) for the next 12 months.

Interventions

TEBOFORTAN DRUG

TEBOFORTAN 240 mg is administrated 1 tablet per day

Arm 1

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Criteria for Mild Cognitive Impairment according to Petersen.
• Global score Deterioration Scale (GDS)=3 and Clinical Dementia Rating (CDR)=0.5.
• Subject's ability to comply with study requirements in the opinion of the investigator.
• Informed consent signed

You may not qualify if:

• Dementia (GDS=4-7) Severe auditory or visual abnormalities that could affect performance on neuropsychological tests.
• Severe psychiatric pathology.
• Hemorrhagic diathesis or anticoagulant treatment.
• Active treatment with anticholinesterase drugs or memantine. History of epilepsy or alcoholism.
• Galactose intolerance, malabsorption of glucose or galactose.
• Previous treatment with EGb 761®.

Sponsors & Collaborators

• Fundació ACE Institut Català de Neurociències Aplicades: lead

Study Sites (1)

Fundació ACE. Institut Català de Neurociències Aplicades.

Barcelona, 08028, Spain

Location

Related Publications (1)

• Morato X, Marquie M, Tartari JP, Lafuente A, Abdelnour C, Alegret M, Jofresa S, Buendia M, Pancho A, Aguilera N, Ibarria M, Diego S, Cuevas R, Canada L, Calvet A, Antonio EE, Perez-Cordon A, Sanabria A, de Rojas I, Nunez-Llaves R, Cano A, Orellana A, Montrreal L, Canabate P, Rosende-Roca M, Vargas L, Bojaryn U, Ricciardi M, Ariton DM, Espinosa A, Ortega G, Munoz N, Lleonart N, Alarcon-Martin E, Moreno M, Preckler S, Tantinya N, Ramis M, Nogales AB, Seguer S, Martin E, Pytel V, Valero S, Gurruchaga M, Tarraga L, Ruiz A, Boada M. A randomized, open-label clinical trial in mild cognitive impairment with EGb 761 examining blood markers of inflammation and oxidative stress. Sci Rep. 2023 Apr 3;13(1):5406. doi: 10.1038/s41598-023-32515-6.

  PMID: 37012306 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Merce Rovira, MD

  Fundació ACE Institut Català de Neurociències Aplicades

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: October 26, 2022
• Study Start: April 16, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 15, 2023

Record last verified: 2023-02

Locations

ES (1)