Status:
UNKNOWN
Modulation of Attention in Event Related Potential (ERPs) as a Marker of Early Cognitive Decline by Ginkgo Biloba
Lead Sponsor:
Jean-François Démonet
Collaborating Sponsors:
University of Lausanne Hospitals
Conditions:
Subjective Cognitive Decline
Cognitive Performance
Eligibility:
All Genders
55-80 years
Phase:
NA
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 E...
Detailed Description
This study is a single-center, randomized clinical trial testing the effects of Ginkgo biloba extracts versus placebo on event related potential ERP registration measurements in Electroencephalography...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2024
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04121728
Start Date
September 9 2019
End Date
May 31 2024
Last Update
January 11 2023
Active Locations (1)
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1
Centre Leenaards de la mémoire (CLM) CHUV
Lausanne, Canton of Vaud, Switzerland, 1011