Age-related Cognitive Decline Clinical Trial
— AgilGinkgoOfficial 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
Verified date | January 2023 |
Source | University of Lausanne Hospitals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Active, not recruiting |
Enrollment | 16 |
Est. completion date | May 31, 2024 |
Est. primary completion date | May 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 55 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Centre Leenaards de la mémoire (CLM) CHUV | Lausanne | Vaud |
Lead Sponsor | Collaborator |
---|---|
Jean-François Démonet | University of Lausanne Hospitals |
Switzerland,
Amieva H, Le Goff M, Millet X, Orgogozo JM, Peres K, Barberger-Gateau P, Jacqmin-Gadda H, Dartigues JF. Prodromal Alzheimer's disease: successive emergence of the clinical symptoms. Ann Neurol. 2008 Nov;64(5):492-8. doi: 10.1002/ana.21509. — View Citation
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. — View Citation
Luck T, Luppa M, Matschinger H, Jessen F, Angermeyer MC, Riedel-Heller SG. Incident subjective memory complaints and the risk of subsequent dementia. Acta Psychiatr Scand. 2015 Apr;131(4):290-6. doi: 10.1111/acps.12328. Epub 2014 Sep 9. — View Citation
Martin CD, Thierry G, Demonet JF. ERP characterization of sustained attention effects in visual lexical categorization. PLoS One. 2010 Mar 25;5(3):e9892. doi: 10.1371/journal.pone.0009892. — View Citation
Tan MS, Yu JT, Tan CC, Wang HF, Meng XF, Wang C, Jiang T, Zhu XC, Tan L. Efficacy and adverse effects of ginkgo biloba for cognitive impairment and dementia: a systematic review and meta-analysis. J Alzheimers Dis. 2015;43(2):589-603. doi: 10.3233/JAD-140837. — View Citation
Thierry G, Doyon B, Demonet JF. ERP mapping in phonological and lexical semantic monitoring tasks: A study complementing previous PET results. Neuroimage. 1998 Nov;8(4):391-408. doi: 10.1006/nimg.1998.0371. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Predictive metrological characteristics of ERP modulation in term of its ability to detect a more sensitive cognitive variation than usual method | a mixed linear model approach will be applied to assess prediction | through study completion, an average of 14 months | |
Other | Predictive metrological characteristics of ERP modulation in term of its ability to detect a slope break during cognitive decline | a mixed linear model approach will be applied to assess prediction | through study completion, an average of 14 months | |
Primary | Reproducibility of contingent negative variation (CNV) event-related potential (ERP) component amplitude (microV) during the Hold-Release (HR) neuropsychological test | Reproducibility of CNV will be assessed by interclass correlation coefficient (ICC) | through study completion, an average of 14 months | |
Primary | Intra-individual variability of contingent negative variation (CNV) event-related potential (ERP) component amplitude (microV) during the Hold-Release (HR) neuropsychological test | Intra-individual variability of CNV will be assessed by Interclass Coefficient Correlation (ICC) | through study completion, an average of 14 months | |
Primary | Reproducibility of P300/P300' event-related potential (ERP) component amplitude (microV) during the Hold-Release (HR) neuropsychological test | Reproducibility of P300/P300' will be assessed by Interclass Coefficient Correlation (ICC) | through study completion, an average of 14 months | |
Primary | Intra-individual variability of P300/P300' event-related potential (ERP) component amplitude (microV) during the Hold-Release (HR) neuropsychological test | Intra-individual variability of P300/P300' will be assessed by Interclass Coefficient Correlation (ICC) | through study completion, an average of 14 months | |
Primary | 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 | the statistical model of repeated measurements of variance analysis will be used | through study completion, an average of 14 months | |
Primary | 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 | the statistical model of repeated measurements of variance analysis will be used | through study completion, an average of 14 months | |
Secondary | 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 | the statistical model of repeated measurements of variance analysis will be used | 6 months | |
Secondary | Change in scores of categorical semantic verbal fluency after 6 months of Ginkgo biloba treatment | the statistical model of repeated measurements of variance analysis will be used | 6 months | |
Secondary | Change in scores of verbal fluency letter instruction after 6 months of Ginkgo biloba treatment | the statistical model of repeated measurements of variance analysis will be used | 6 months | |
Secondary | Change in anxiety and depression as assessed using the Hospital Anxiety and Depression Scale (HAD-A/D) after 6 months of Ginkgo biloba treatment | the statistical model of repeated measurements of variance analysis will be used | 6 months | |
Secondary | Change in reaction time (ms) during the Hold-Release (HR) neuropsychological test after 6 months of Ginkgo biloba treatment | the statistical model of repeated measurements of variance analysis will be used | 6 months | |
Secondary | 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. | Combination of an analysis of variance (ANOVA) in repeated measurements and an analysis of variance (ANOVA) in correlation analysis will be used to assess respectively differences (microV) between measurement sessions and the existence of shared associations (correlation coefficient). | through study completion, an average of 14 months | |
Secondary | Magnitude of repetition effects (Test-retest Reliability, TTR) on P300/P300' event-related potential (ERP) component during the Hold-Release (HR) neuropsychological test. | Combination of an analysis of variance (ANOVA) in repeated measurements and an analysis of variance (ANOVA) in correlation analysis will be used to assess respectively differences (microV) between measurement sessions and the existence of shared associations (correlation coefficient). | through study completion, an average of 14 months | |
Secondary | 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. | a mixed linear model approach will be applied to assess prediction | through study completion, an average of 14 months | |
Secondary | 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. | a mixed linear model approach will be applied to assess prediction | through study completion, an average of 14 months | |
Secondary | 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 | a mixed linear model approach will be applied to assess prediction | through study completion, an average of 14 months | |
Secondary | 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 | a mixed linear model approach will be applied to assess prediction | through study completion, an average of 14 months |
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