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

Primary Purpose

Mild Cognitive Impairment (MCI)

Status
Active
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
TEBOFORTAN
Sponsored by
Fundació ACE Institut Català de Neurociències Aplicades
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment (MCI)

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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®.

Sites / Locations

  • Fundació ACE. Institut Català de Neurociències Aplicades.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Arm 1

Arm 2

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).
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
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.

Full Information

First Posted
October 17, 2022
Last Updated
February 14, 2023
Sponsor
Fundació ACE Institut Català de Neurociències Aplicades
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1. Study Identification

Unique Protocol Identification Number
NCT05594355
Brief Title
Effect of Treatment With EGb 761(r) on Blood Markers of Inflammation and Oxidative Stress in Patients With MCI
Official Title
Effect of Treatment With EGb 761(r) on Blood Markers of Inflammation and Oxidative Stress in a Cohort of Patients With Mild Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 16, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació ACE Institut Català de Neurociències Aplicades

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment (MCI)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Treatment with EGb 761® (TEBOFORTAN 240 mg) during 24 months.
Arm Title
Arm 2
Arm Type
No Intervention
Arm Description
No Treatment during 12 months and treatment with EGb 761® (TEBOFORTAN 240 mg) for the next 12 months.
Intervention Type
Drug
Intervention Name(s)
TEBOFORTAN
Intervention Description
TEBOFORTAN 240 mg is administrated 1 tablet per day
Primary Outcome Measure Information:
Title
Compare changes in blood marker levels of inflammation and oxidation
Description
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
Time Frame
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 Measure Information:
Title
Compare scores on neuropsychiatric tests
Description
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).
Time Frame
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.
Title
Compare changes in cognitive test scores
Description
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
Time Frame
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.
Title
Obtain data of changes in blood marker levels of inflammation and oxidative stress and security data
Description
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.
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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®.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merce Rovira, MD
Organizational Affiliation
Fundació ACE Institut Català de Neurociències Aplicades
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fundació ACE. Institut Català de Neurociències Aplicades.
City
Barcelona
ZIP/Postal Code
08028
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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