Modulation of Attention in Event Related Potential (ERPs) as a Marker of Early Cognitive Decline by Ginkgo Biloba

NCT04121728 | Unknown

• 1 other identifier: 2018-02134 BASEC
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Conditions

Subjective Cognitive Decline; Cognitive Performance; Functional Capacity; Age-related Cognitive Decline

Keywords

metrological characteristics of EEG-ERP; Ginkgo Biloba

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (11)

• 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

  6 months

• Change in scores of categorical semantic verbal fluency after 6 months of Ginkgo biloba treatment

  6 months

• Change in scores of verbal fluency letter instruction after 6 months of Ginkgo biloba treatment

  6 months

• Change in anxiety and depression as assessed using the Hospital Anxiety and Depression Scale (HAD-A/D) after 6 months of Ginkgo biloba treatment

  6 months

• Change in reaction time (ms) during the Hold-Release (HR) neuropsychological test after 6 months of Ginkgo biloba treatment

  6 months

Other Outcomes (2)

• Predictive metrological characteristics of ERP modulation in term of its ability to detect a more sensitive cognitive variation than usual method

  through study completion, an average of 14 months

• Predictive metrological characteristics of ERP modulation in term of its ability to detect a slope break during cognitive decline

  through study completion, an average of 14 months

Study Arms (2)

Group Ginkgo-Placebo

OTHER

Cross-over design: In Group Ginkgo-Placebo participants are allocated first to the IMP Symfona® during 6 months and after 2 months of wash-out period are allocated to the placebo for 6 months.

Drug: Ginkgo biloba extract; Drug: Placebo

Group Placebo-Ginkgo

OTHER

Cross-over design:In Group Placebo-Ginkgo participants are allocated first to the placebo during 6 months and after 2 months of wash-out period are allocated the IMP Symfona® for 6 months.

Drug: Ginkgo biloba extract; Drug: Placebo

Interventions

Ginkgo biloba extract DRUG

Symfona® commercial standardized Ginkgo biloba extracts are used in this study, at a rate of 2 capsules of 120 mg per day for 170 days.

Also known as: Symfona®

Group Ginkgo-Placebo; Group Placebo-Ginkgo

Placebo DRUG

The placebo is presented in the form of capsules of identical mass, color and shape to those of the study product. It is composed of lactose, the excipients present in Symfona® 120 mg and colorants. The dosage is identical to that of the investigational product.

Also known as: Placebo caps

Group Ginkgo-Placebo; Group Placebo-Ginkgo

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed consent form
• men and women
• to 80 years old
• Diagnostic of Subjective complain
• Understanding the 2 Hold-Release tasks in ERP

You may not qualify if:

• 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

Sponsors & Collaborators

• Jean-François Démonet: lead
• University of Lausanne Hospitals: collaborator

Study Sites (1)

Centre Leenaards de la mémoire (CLM) CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (6)

• 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.

  PMID: 19067364 BACKGROUND

• 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.

  PMID: 25201166 BACKGROUND

• 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.

  PMID: 9811557 BACKGROUND

• 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.

  PMID: 20361039 BACKGROUND

• 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.

  PMID: 25114079 BACKGROUND

• 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.

  PMID: 12895688 BACKGROUND

MeSH Terms

Interventions

Ginkgo biloba extract

Study Officials

• Jean-François Démonet, Prof

  Universitary Lausanne Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigational Medicinal Product (IMP), e.g Placebo and Ginkgo Biloba, is located and dispensed by Central Pharmacy. Only pharmacists are not blinded but they are neither involved in the conduct of the study not the analysis of the results
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, MD.PhD

Model Details: randomized double-blind crossover design

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: October 10, 2019
• Study Start: September 9, 2019
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: January 11, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)