UnknownNot Applicable

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

Switzerland16 participantsStarted 2019-09-09

Plain-language 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

Who can participate

Age range55 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Reproducibility of contingent negative variation (CNV) event-related potential (ERP) component amplitude (microV) during the Hold-Release (HR) neuropsychological test

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Trial details

NCT IDNCT04121728

SponsorJean-François Démonet

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-31

View on ClinicalTrials.gov More Subjective Cognitive Decline trials