Clinical trial NCT04121728: Modulation of Attention in Event Related Potential (ERPs) as a Marker of Early Cognitive Decline by Ginkgo Biloba
Official title: Evaluation of the Modulation of Attention Explored in ERPs as a Marker of Early Cognitive Decline: Concept Validation on the Effect of Ginkgo Biloba Extracts. Randomized, Double-blind, Cross-over, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Subjective Cognitive Decline
Cognitive Performance
Functional Capacity
Age-related Cognitive Decline
Keywords: metrological characteristics of EEG-ERP
Ginkgo Biloba
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
Collaborators: name: University of Lausanne Hospitals
First posted: 2019-10-10
Enrollment: 16
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: randomized double-blind crossover design
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Reproducibility of contingent negative variation (CNV) event-related potential (ERP) component amplitude (microV) during the Hold-Release (HR) neuropsychological test
timeFrame: through study completion, an average of 14 months
measure: Intra-individual variability of contingent negative variation (CNV) event-related potential (ERP) component amplitude (microV) during the Hold-Release (HR) neuropsychological test
timeFrame: through study completion, an average of 14 months
measure: Reproducibility of P300/P300' event-related potential (ERP) component amplitude (microV) during the Hold-Release (HR) neuropsychological test
timeFrame: through study completion, an average of 14 months
measure: Intra-individual variability of P300/P300' event-related potential (ERP) component amplitude (microV) during the Hold-Release (HR) neuropsychological test
timeFrame: through study completion, an average of 14 months
measure: Change in cognitive performance as assessed by variation in amplitude (mivroV) of the CNV component measured during the Hold-Release (HR) neuropsychological test after 6 months of Ginkgo biloba treatment
timeFrame: through study completion, an average of 14 months
measure: Change in cognitive performance as assessed by variation in amplitude (mivroV) of the P300/P300' component measured during the Hold-Release (HR) neuropsychological test after 6 months of Ginkgo biloba treatment
timeFrame: through study completion, an average of 14 months
Secondary outcomes:
measure: Change in cognitive performance as assessed using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) test after 6 months of Ginkgo biloba treatment
timeFrame: 6 months
measure: Change in scores of categorical semantic verbal fluency after 6 months of Ginkgo biloba treatment
timeFrame: 6 months
measure: Change in scores of verbal fluency letter instruction after 6 months of Ginkgo biloba treatment
timeFrame: 6 months
measure: Change in anxiety and depression as assessed using the Hospital Anxiety and Depression Scale (HAD-A/D) after 6 months of Ginkgo biloba treatment
timeFrame: 6 months
measure: Change in reaction time (ms) during the Hold-Release (HR) neuropsychological test after 6 months of Ginkgo biloba treatment
timeFrame: 6 months
measure: Magnitude of repetition effects (Test-retest Reliability, TTR) on the contingent negative variation (CNV) event-related potential (ERP) component during the Hold-Release (HR) neuropsychological test.
timeFrame: through study completion, an average of 14 months
measure: Magnitude of repetition effects (Test-retest Reliability, TTR) on P300/P300' event-related potential (ERP) component during the Hold-Release (HR) neuropsychological test.
timeFrame: through study completion, an average of 14 months
measure: Association (correlation coefficient) between a transversal measurement of VPN event-related potential (ERP) component during the Hold-Release (HR) neuropsychological test and the conventional verbal fluency scores.
timeFrame: through study completion, an average of 14 months
measure: Association (correlation coefficient) between a transversal measurement of P300/P300' event-related potential (ERP) component during the Hold-Release (HR) neuropsychological test and the conventional verbal fluency scores.
timeFrame: through study completion, an average of 14 months
measure: Association (correlation coefficient) between a transversal measurement of VPN event-related potential (ERP) component during the Hold-Release (HR) neuropsychological test and evolution of its own value during the participant's follow-up
timeFrame: through study completion, an average of 14 months
measure: Association (correlation coefficient) between a transversal measurement of P300/P300' event-related potential (ERP) component during the Hold-Release (HR) neuropsychological test and evolution of its own value during the participant's follow-up
timeFrame: through study completion, an average of 14 months
Other outcomes:
measure: Predictive metrological characteristics of ERP modulation in term of its ability to detect a more sensitive cognitive variation than usual method
timeFrame: through study completion, an average of 14 months
measure: Predictive metrological characteristics of ERP modulation in term of its ability to detect a slope break during cognitive decline
timeFrame: through study completion, an average of 14 months
Locations:
city: Lausanne
country: Switzerland
facility: Centre Leenaards de la mémoire (CLM) CHUV
state: Vaud
Study officials:
affiliation: Universitary Lausanne Hospital
name: Jean-François Démonet, Prof
role: PRINCIPAL_INVESTIGATOR
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