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

Jean-François Démonet

Status: Active, not recruiting

Conditions: Functional Capacity; Age-related Cognitive Decline; Cognitive Performance; Subjective Cognitive Decline

Treatments: Drug: Placebo; Drug: Ginkgo biloba extract

Study type: Interventional

Funder types: Other

Identifiers

NCT04121728

2018-02134 BASEC

Details and patient eligibility

About

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

Full description

This study is a single-center, randomized clinical trial testing the effects of Ginkgo biloba extracts versus placebo on event related potential ERP registration measurements in Electroencephalography (EEG) during neuropsychological tasks. The Hold-Release (HR) neuropsychological test allows the study of behavioral and neurofunctional correlates using several different techniques for online recording of brain activity. This test measures the engagement of focused attention and the loading of information into working memory, as opposed to the disengagement of attention.

The study will be carried out in a randomized cross-over design, with "Ginkgo" vs. Placebo", or inversely, for 170 days each (approximately 6 months), separated by an 8-weeks wash-out period. A follow-up visit will be held 3 months after the last treatment of the study.

The cross-over design uses each patient as its own control, which allows an easy comparison between the 2 groups "Placebo" vs. "Ginkgo" by limiting inter-patient variations. In addition, by doubling the number of patients per treatment compared to a classic study design in 2 groups, cross-over reduces the number of patients to be recruited, which facilitates recruitment on a single site.

The study requires the recruitment of sixteen (16) informative participants with cognitive complaints.

Enrollment: 16 patients

Sex: All

Ages: 55 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Signed consent form
• men and women
• 60 to 80 years old
• Diagnostic of Subjective complain
• Understanding the 2 Hold-Release tasks in ERP

Exclusion Criteria:

• Montreal Cognitive Evaluation Score (MoCA) <24
• 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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16 participants in 2 patient groups

Group Ginkgo-Placebo

Other group

Description:

Cross-over design: In Group Ginkgo-Placebo participants are allocated first to the IMP Symfona® during 6 months and after 2 months of wash-out period are allocated to the placebo for 6 months.

Treatment:

Drug: Ginkgo biloba extract

Drug: Placebo

Group Placebo-Ginkgo

Other group

Description:

Cross-over design:In Group Placebo-Ginkgo participants are allocated first to the placebo during 6 months and after 2 months of wash-out period are allocated the IMP Symfona® for 6 months.

Treatment:

Drug: Ginkgo biloba extract

Drug: Placebo