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

Fundació ACE Institut Català de Neurociències Aplicades

Status and phase: Active, not recruiting; Phase 4

Conditions: Mild Cognitive Impairment (MCI)

Treatments: Drug: TEBOFORTAN

Study type: Interventional

Funder types: Other

Identifiers

NCT05594355

ACE-2020-EGb761

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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®.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Arm 1

Experimental group

Description:

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

Treatment:

Drug: TEBOFORTAN

Arm 2

No Intervention group

Description:

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