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

• Status: Active, not recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundació ACE Institut Català de Neurociències Aplicades

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®.