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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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23 January 2023 |
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Main ID: |
NCT04121728 |
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Date of registration:
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18/09/2019 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Modulation of Attention in Event Related Potential (ERPs) as a Marker of Early Cognitive Decline by Ginkgo Biloba
AgilGinkgo |
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Scientific title:
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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 |
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Date of first enrolment:
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September 9, 2019 |
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Target sample size:
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16 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT04121728 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Diagnostic. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Jean-François Démonet, Prof |
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Address:
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Telephone:
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Email:
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Affiliation:
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Universitary Lausanne Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
55 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Age-related Cognitive Decline
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Subjective Cognitive Decline
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Functional Capacity
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Cognitive Performance
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Intervention(s)
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Drug: Ginkgo biloba extract
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Drug: Placebo
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Primary Outcome(s)
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Intra-individual variability of contingent negative variation (CNV) event-related potential (ERP) component amplitude (microV) during the Hold-Release (HR) neuropsychological test
[Time Frame: through study completion, an average of 14 months]
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Reproducibility of contingent negative variation (CNV) event-related potential (ERP) component amplitude (microV) during the Hold-Release (HR) neuropsychological test
[Time Frame: through study completion, an average of 14 months]
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Reproducibility of P300/P300' event-related potential (ERP) component amplitude (microV) during the Hold-Release (HR) neuropsychological test
[Time Frame: through study completion, an average of 14 months]
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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
[Time Frame: through study completion, an average of 14 months]
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Intra-individual variability of P300/P300' event-related potential (ERP) component amplitude (microV) during the Hold-Release (HR) neuropsychological test
[Time Frame: through study completion, an average of 14 months]
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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
[Time Frame: through study completion, an average of 14 months]
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Secondary Outcome(s)
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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
[Time Frame: through study completion, an average of 14 months]
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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.
[Time Frame: through study completion, an average of 14 months]
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Change in reaction time (ms) during the Hold-Release (HR) neuropsychological test after 6 months of Ginkgo biloba treatment
[Time Frame: 6 months]
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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
[Time Frame: through study completion, an average of 14 months]
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Change in anxiety and depression as assessed using the Hospital Anxiety and Depression Scale (HAD-A/D) after 6 months of Ginkgo biloba treatment
[Time Frame: 6 months]
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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
[Time Frame: 6 months]
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Change in scores of verbal fluency letter instruction after 6 months of Ginkgo biloba treatment
[Time Frame: 6 months]
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Magnitude of repetition effects (Test-retest Reliability, TTR) on P300/P300' event-related potential (ERP) component during the Hold-Release (HR) neuropsychological test.
[Time Frame: through study completion, an average of 14 months]
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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.
[Time Frame: through study completion, an average of 14 months]
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Change in scores of categorical semantic verbal fluency after 6 months of Ginkgo biloba treatment
[Time Frame: 6 months]
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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.
[Time Frame: through study completion, an average of 14 months]
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Secondary ID(s)
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2018-02134 BASEC
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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