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

NCT ID: NCT04121728

Last Updated: 2023-01-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-09
• Study Completion Date: 2024-05-31

Brief 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

Detailed 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: QUADRUPLE

Study Groups

Group Ginkgo-Placebo

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.

Group Type: OTHER

Ginkgo biloba extract

Intervention Type: DRUG

Symfona® commercial standardized Ginkgo biloba extracts are used in this study, at a rate of 2 capsules of 120 mg per day for 170 days.

Placebo

Intervention Type: DRUG

The placebo is presented in the form of capsules of identical mass, color and shape to those of the study product. It is composed of lactose, the excipients present in Symfona® 120 mg and colorants. The dosage is identical to that of the investigational product.

Group Placebo-Ginkgo

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.

Group Type: OTHER

Ginkgo biloba extract

Intervention Type: DRUG

Symfona® commercial standardized Ginkgo biloba extracts are used in this study, at a rate of 2 capsules of 120 mg per day for 170 days.

Placebo

Intervention Type: DRUG

The placebo is presented in the form of capsules of identical mass, color and shape to those of the study product. It is composed of lactose, the excipients present in Symfona® 120 mg and colorants. The dosage is identical to that of the investigational product.

Interventions

Ginkgo biloba extract

Symfona® commercial standardized Ginkgo biloba extracts are used in this study, at a rate of 2 capsules of 120 mg per day for 170 days.

Intervention Type: DRUG

Placebo

The placebo is presented in the form of capsules of identical mass, color and shape to those of the study product. It is composed of lactose, the excipients present in Symfona® 120 mg and colorants. The dosage is identical to that of the investigational product.

Intervention Type: DRUG

Other Intervention Names

Symfona®; Placebo caps

Eligibility 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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Lausanne Hospitals

OTHER

Sponsor Role: collaborator

Jean-François Démonet

OTHER

Sponsor Role: lead

Responsible Party

Jean-François Démonet

Professor, MD.PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jean-François Démonet, Prof

Role: PRINCIPAL_INVESTIGATOR

Universitary Lausanne Hospital

Locations

Centre Leenaards de la mémoire (CLM) CHUV

Lausanne, Canton of Vaud, Switzerland

Countries

Switzerland

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 20361039 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 25114079 (View on PubMed)

Kennedy DO, Scholey AB, Drewery L, Marsh VR, Moore B, Ashton H. Electroencephalograph effects of single doses of Ginkgo biloba and Panax ginseng in healthy young volunteers. Pharmacol Biochem Behav. 2003 Jun;75(3):701-9. doi: 10.1016/s0091-3057(03)00120-5.

Reference Type: BACKGROUND

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Other Identifiers

2018-02134 BASEC

Identifier Type: -

Identifier Source: org_study_id