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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Treatment With EGb 761(r) on Blood Markers of Inflammation and Oxidative Stress in a Cohort of Patients With Mild Cognitive Impairment

Conditions
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Mild Cognitive Impairment (MCI)

Intervention / Treatment
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* Drug: TEBOFORTAN


Participation Criteria
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Eligibility Criteria
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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®.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Treatment with EGb 761® (TEBOFORTAN 240 mg) during 24 months. | Drug: TEBOFORTAN<br>* TEBOFORTAN 240 mg is administrated 1 tablet per day<br>|
| No Intervention: Arm 2<br>No Treatment during 12 months and treatment with EGb 761® (TEBOFORTAN 240 mg) for the next 12 months. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare scores on neuropsychiatric tests | A neuropsychological evaluation will be performed in v0, v2 and v4. The neuropsychological battery may be administered in person or telematically indistinctly. Fundació ACE Battery (N-BACE) (Alegret M et al., 2012, Alegret M et al., 2013). | 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 | Neurological evaluation will be performed in v0, v2 and v4. It consists of a structured anamnesis of the patient and an informant. Data on age, sex, educational level, medical history, including cardiovascular risk factors, and treatment received are collected. A complete neurological examination using the Spanish version of the Mini Mental State Examination test is administered. Hachinski ischemia scale, the Spanish version of the Neuropsychiatric Inventory Questionnaire, the Global Deterioration Scale, the Clinical Dementia Rating and the Blessed scale. follow-up visit between the study group and the control group | 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 | Obtain data on levels of blood markers of inflammation and oxidative stress and safety for two years in the group receiving EGb761® during the first 12 month of the study and one year in the group control.Blood markers of inflammation and oxidation: in 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. | 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. |