Modulation of Attention in Event Related Potential (ERPs) as a Marker of Early Cognitive Decline by Ginkgo Biloba

• Status: Enrolling by invitation
• Trial end date: 2022-05-31
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to simultaneously establish the metrological characteristics of the new executive function markers (decision making and multiple flow management) derived from repeated ERP variations and to identify their ability to test whether a short treatment using Ginkgo biloba versus placebo extracts can modify the cognitive performance and functional capacity of patients in the very early stages of age-related cognitive decline. This trial, using subjects as their own control (cross-over) in repeated measurements will establish the reproducibility characteristics of the measurements and intra-individual variations of ERP over time in this population

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Jean-François Démonet
• Collaborator: University of Lausanne Hospitals

Criteria

Inclusion Criteria

• Signed consent form

• men and women

• 60 to 80 years old

• Cognitive Complaint Questionnaire (CQC) Score > 4

Exclusion Criteria:

• Montreal Cognitive Evaluation Score (MoCA) <26

• Overall Clinical Dementia Rating (CDR) score > 0.5

• Scores of the Hospital Anxiety and Depression Scale (HADS): HADS-A (Anxiety) > 8 and/or HADS-D (Depression) > 8

• Mild Cognitive Impairment (MCI) or dementia

• Contraindication to MRI

• Atrophy of any region of the brain as seen in the T1 volumetric MRI sequence

• Any uncontrolled somatic or psychiatric condition

• Bleeding disorders, and/or taking medications that increase the risk of bleeding,

• Hypersensitivity to Ginkgo biloba or any of its excipients

• Lactose intolerance

• Treatment with barbiturates and/or neuroleptics

• Ongoing treatment with Ginkgo biloba derivatives (a period of 2 months without treatment before inclusion is required