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
Descrizione riassuntiva dello studio
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)
Intervento studiato
-> 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)
Malattie studiate
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)
Criteri di esclusione
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)
Luogo dello studio
Losanna
(BASEC)
Sponsor
NA
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Dr Olivier Rouaud
021 314 11 84
olivier.rouaud@clutterchuv.chCHUV
(BASEC)
Informazioni generali
Universitary Lausanne Hospital
(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Vaud
(BASEC)
Data di approvazione del comitato etico
09.04.2019
(BASEC)
ID di studio ICTRP
NCT04121728 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
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)
Titolo accademico
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)
Titolo pubblico
Modulation of Attention in Event Related Potential (ERPs) as a Marker of Early Cognitive Decline by Ginkgo Biloba (ICTRP)
Malattie studiate
Age-related Cognitive Decline
Subjective Cognitive Decline
Functional Capacity
Cognitive Performance
(ICTRP)
Intervento studiato
Drug: Ginkgo biloba extract
Drug: Placebo
(ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Diagnostic. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
Criteri di inclusione/esclusione
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)
non disponibile
Endpoint primari e secondari
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)
Data di registrazione
18.09.2019 (ICTRP)
Inclusione del primo partecipante
09.09.2019 (ICTRP)
Sponsor secondari
University of Lausanne Hospitals
(ICTRP)
Contatti aggiuntivi
Jean-François Démonet, Prof, Universitary Lausanne Hospital (ICTRP)
ID secondari
2018-02134 BASEC (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT04121728 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile