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

NCT ID: NCT05594355

Last Updated: 2023-02-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-16
• Study Completion Date: 2023-12-31

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.

Detailed Description

This treatment is based on a plant called Gingko Biloba. In the study, half of the participants would be administered EGb 761® during 24 months and the other half would not receive this treatment during 12 months and will received EGb 761® for the next 12 months.

Conditions

Mild Cognitive Impairment (MCI)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

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

Group Type: EXPERIMENTAL

TEBOFORTAN

Intervention Type: DRUG

TEBOFORTAN 240 mg is administrated 1 tablet per day

Arm 2

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

TEBOFORTAN

TEBOFORTAN 240 mg is administrated 1 tablet per day

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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®.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundació ACE Institut Català de Neurociències Aplicades

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Merce Rovira, MD

Role: PRINCIPAL_INVESTIGATOR

Fundació ACE Institut Català de Neurociències Aplicades

Locations

Fundació ACE. Institut Català de Neurociències Aplicades.

Barcelona, , Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 37012306 (View on PubMed)

Other Identifiers

ACE-2020-EGb761

Identifier Type: -

Identifier Source: org_study_id