Evaluation of attention modulation explored through the measurement of event-related potentials (Event-Related Potential, ERPs) in electroencephalography (EEG) as a marker of early cognitive decline: concept validation on the effect of Ginkgo biloba extracts. Randomized double-blind, crossover, placebo-controlled study
Summary description of the study
In this study, 16 patients consulting at the Leenaards Memory Center at CHUV will receive either the treatment (Ginkgo Biloba extracts, Symfona®, Om Pharma, S.A) or a placebo for 6 months. 2 months after this first study period, the allocations will be switched, with patients who initially received the placebo receiving the treatment and vice versa. Neither the medical team nor the participants will know the order of assignment (double-blind study). The total duration of participation is 17 months, including a follow-up visit 3 months after the last treatment intake. The effect of the treatment will be measured by electroencephalography (EEG) data measuring the variability of electrical signals (event-related potentials) sent by the brain during the performance of a specific task. This specific task includes visual and semantic tests in which a subject's attention is manipulated (Hold-Release test, HR test) and allows highlighting a difference in neural activity between stable and declining subjects. The decline here refers to cognitive abilities such as memory, decision-making, or language that are less effective. Memory tests will also be used to measure the effects of the treatment. This trial, using subjects as their own controls (crossover) in repeated measures, will establish the reliability of the methodology used (event-related potentials in an H/R test) as well as the effect of Ginkgo intake on cognitive performance in the studied population.
(BASEC)
Intervention under investigation
-> evaluation of the effects of Ginkgo Biloba extracts (Symfona®, Om Pharma, S.A), 2 capsules of 120mg/capsule per day, for 170 days (approximately 6 months) against placebo on cognitive performance and functional capacity
-> evaluation of the reproducibility of the measurement of event-related potentials recorded by EEG on a Hold-Release task.
(BASEC)
Disease under investigation
This study focuses on the evolution of subjective cognitive complaints in the elderly. This condition is referred to as 'Subjective Cognitive Decline (SCD).' This condition relates to individuals complaining of declining cognitive abilities such as memory, decision-making, or language, while standard tests do not reveal clinically significant deficits in these cognitive areas, although some subtle deficits may be noted.
(BASEC)
men or women aged between 55 and 80 years diagnosis of subjective complaint regardless of QPC score understanding of semantic and visual hold-release tasks in ERP. (BASEC)
Exclusion criteria
Mild Cognitive Impairment (MCI) or dementia; diagnosis verified by standard neuropsychological tests. Contraindication to MRI Hemorrhagic disorders and/or intake of medications that increase the hemorrhagic risk. (BASEC)
Trial sites
Lausanne
(BASEC)
Sponsor
NA
(BASEC)
Contact
Contact Person Switzerland
Dr Olivier Rouaud
021 314 11 84
olivier.rouaud@clutterchuv.chCHUV
(BASEC)
General Information
Universitary Lausanne Hospital
(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Vaud
(BASEC)
Date of authorisation
09.04.2019
(BASEC)
ICTRP Trial ID
NCT04121728 (ICTRP)
Official title (approved by ethics committee)
Evaluation de la modulation de l’attention explorée en ERPs comme marqueur du déclin cognitif précoce : validation de concept sur l’effet des extraits de Ginkgo biloba. Etude randomisée en double aveugle, cross-over, contrôlée par placebo. (BASEC)
Academic 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 (ICTRP)
Public title
Modulation of Attention in Event Related Potential (ERPs) as a Marker of Early Cognitive Decline by Ginkgo Biloba (ICTRP)
Disease under investigation
Age-related Cognitive Decline
Subjective Cognitive Decline
Functional Capacity
Cognitive Performance
(ICTRP)
Intervention under investigation
Drug: Ginkgo biloba extract
Drug: Placebo
(ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Diagnostic. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
Inclusion/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
(ICTRP)
not available
Primary and secondary end points
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
Reproducibility of P300/P300' event-related potential (ERP) component amplitude (microV) during the Hold-Release (HR) neuropsychological test
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
Intra-individual variability of P300/P300' event-related potential (ERP) component amplitude (microV) during the Hold-Release (HR) neuropsychological test
Intra-individual variability of contingent negative variation (CNV) event-related potential (ERP) component amplitude (microV) during the Hold-Release (HR) neuropsychological test
Reproducibility of contingent negative variation (CNV) event-related potential (ERP) component amplitude (microV) during the Hold-Release (HR) neuropsychological test
(ICTRP)
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.
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.
Change in anxiety and depression as assessed using the Hospital Anxiety and Depression Scale (HAD-A/D) after 6 months of Ginkgo biloba treatment
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
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
Magnitude of repetition effects (Test-retest Reliability, TTR) on P300/P300' event-related potential (ERP) component during the Hold-Release (HR) neuropsychological test.
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.
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
Change in reaction time (ms) during the Hold-Release (HR) neuropsychological test after 6 months of Ginkgo biloba treatment
Change in scores of categorical semantic verbal fluency after 6 months of Ginkgo biloba treatment
Change in scores of verbal fluency letter instruction after 6 months of Ginkgo biloba treatment
(ICTRP)
Registration date
18.09.2019 (ICTRP)
Incorporation of the first participant
09.09.2019 (ICTRP)
Secondary sponsors
University of Lausanne Hospitals
(ICTRP)
Additional contacts
Jean-François Démonet, Prof, Universitary Lausanne Hospital (ICTRP)
Secondary trial IDs
2018-02134 BASEC (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT04121728 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available