Clinical trial NCT05594355: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Mild Cognitive Impairment (MCI)
Lead sponsor: Fundació ACE Institut Català de Neurociències Aplicades
Sponsor class: OTHER
First posted: 2022-10-26
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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®.

Primary outcomes:
measure: Compare changes in blood marker levels of inflammation and oxidation
timeFrame: 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 outcomes:
measure: Compare scores on neuropsychiatric tests
timeFrame: 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.
measure: Compare changes in cognitive test scores
timeFrame: 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.
measure: Obtain data of changes in blood marker levels of inflammation and oxidative stress and security data
timeFrame: 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.
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Fundació ACE. Institut Català de Neurociències Aplicades.
Study officials:
affiliation: Fundació ACE Institut Català de Neurociències Aplicades
name: Merce Rovira, MD
role: PRINCIPAL_INVESTIGATOR
References: