Subjective Cognitive DeclineAgilGinkgoNCT04121728
Modulation of Attention in Event Related Potential (ERPs) as a Marker of Early Cognitive Decline by Ginkgo Biloba
A study testing Ginkgo biloba extract in people with Subjective Cognitive Decline and Cognitive Performance, run by Jean-François Démonet at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Subjective Cognitive Decline, Cognitive Performance, Functional Capacity
- What is being tested?
- Ginkgo biloba extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteSwitzerland
- Study dates
- 9 Sep 2019to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed consent form
- men and women
- 60 to 80 years old
- Diagnostic of Subjective complain
- Understanding the 2 Hold-Release tasks in ERP
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre Leenaards de la mémoire (CLM) CHUV
Lausanne, Canton of Vaud, 1011
About this study
Official 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
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
Read the 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 (EEG) during neuropsychological tasks. The Hold-Release (HR) neuropsychological test allows the study of behavioral and neurofunctional correlates using several different techniques for online recording of brain activity. This test measures the engagement of focused attention and the loading of information into working memory, as opposed to the disengagement of attention.
The study will be carried out in a randomized cross-over design, with "Ginkgo" vs. Placebo", or inversely, for 170 days each (approximately 6 months), separated by an 8-weeks wash-out period. A follow-up visit will be held 3 months after the last treatment of the study.
The cross-over design uses each patient as its own control, which allows an easy comparison between the 2 groups "Placebo" vs. "Ginkgo" by limiting inter-patient variations. In addition, by doubling the number of patients per treatment compared to a classic study design in 2 groups, cross-over reduces the number of patients to be recruited, which facilitates recruitment on a single site.
The study requires the recruitment of sixteen (16) informative participants with cognitive complaints.
- Conditions
- Subjective Cognitive Decline, Cognitive Performance, Functional Capacity, Age-related Cognitive Decline
- Being tested
- Ginkgo biloba extract, Placebo
- Keywords
- metrological characteristics of EEG-ERP, Ginkgo Biloba
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ginkgo biloba extractDrug
Also called Symfona®
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.
PlaceboDrug
Also called Placebo caps
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Ginkgo biloba extract; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
the statistical model of repeated measurements of variance analysis will be used
Measured: 6 months
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
Measured: 6 months
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
Measured: 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
the statistical model of repeated measurements of variance analysis will be used
Measured: 6 months
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
Measured: 6 months
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).
Measured: through study completion, an average of 14 months
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).
Measured: through study completion, an average of 14 months
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
Measured: through study completion, an average of 14 months
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
Measured: through study completion, an average of 14 months
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
Measured: through study completion, an average of 14 months
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
Measured: through study completion, an average of 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start9 Sep 2019
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Subjective Cognitive DeclineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- randomized double-blind crossover design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jean-François Démonet
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lausanne Hospitals
- Responsible party
- Sponsor-investigator, Jean-François Démonet, University of Lausanne Hospitals
- Investigators
- Jean-François Démonet, Prof, Principal investigator, Universitary Lausanne Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04121728
- Sponsor's protocol ID
- 2018-02134 BASEC
- Other IDs
- 2018
- Acronym
- AgilGinkgo
- Status last verified
- Jan 2023
- First submitted
- 18 Sep 2019
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19067364Luck 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.
PubMed 25201166Thierry 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.
PubMed 9811557Martin 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.
PubMed 20361039Tan 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.
PubMed 25114079Kennedy 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.
PubMed 12895688
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04121728
- Acronym / sponsor ID
- AgilGinkgo / 2018-02134 BASEC
- Conditions
- Subjective Cognitive Decline, Cognitive Performance, Functional Capacity, Age-related Cognitive Decline
- Keywords
- metrological characteristics of EEG-ERP, Ginkgo Biloba
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Jean-François DémonetUniversity, hospital or other
- Collaborators
- University of Lausanne Hospitals
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 10 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 (EEG) during neuropsychological tasks. The Hold-Release (HR) neuropsychological test allows the study of behavioral and neurofunctional correlates using several different techniques for online recording of brain activity. This test measures the engagement of focused attention and the loading of information into working memory, as opposed to the disengagement of attention.
The study will be carried out in a randomized cross-over design, with "Ginkgo" vs. Placebo", or inversely, for 170 days each (approximately 6 months), separated by an 8-weeks wash-out period. A follow-up visit will be held 3 months after the last treatment of the study.
The cross-over design uses each patient as its own control, which allows an easy comparison between the 2 groups "Placebo" vs. "Ginkgo" by limiting inter-patient variations. In addition, by doubling the number of patients per treatment compared to a classic study design in 2 groups, cross-over reduces the number of patients to be recruited, which facilitates recruitment on a single site.
The study requires the recruitment of sixteen (16) informative participants with cognitive complaints.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized double-blind crossover design
| Arm | Type | Receives |
|---|---|---|
| Group Ginkgo-Placebo | Other | Drug: Ginkgo biloba extract, Drug: PlaceboCross-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. |
| Group Placebo-Ginkgo | Other | Drug: Ginkgo biloba extract, Drug: PlaceboCross-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. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed consent form
- men and women
- 60 to 80 years old
- Diagnostic of Subjective complain
- Understanding the 2 Hold-Release tasks in ERP
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ginkgo biloba extractAlso: Symfona®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. | Drug | Group Ginkgo-Placebo, Group Placebo-Ginkgo |
| PlaceboAlso: Placebo capsThe 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. | Drug | Group Ginkgo-Placebo, Group Placebo-Ginkgo |
Primary outcome
Reproducibility of contingent negative variation (CNV) event-related potential (ERP) component amplitude (microV) during the Hold-Release (HR) neuropsychological test
Time frame: through study completion, an average of 14 months
Reproducibility of CNV will be assessed by interclass correlation coefficient (ICC)
Intra-individual variability of contingent negative variation (CNV) event-related potential (ERP) component amplitude (microV) during the Hold-Release (HR) neuropsychological test
Time frame: through study completion, an average of 14 months
Intra-individual variability of CNV will be assessed by Interclass Coefficient Correlation (ICC)
Reproducibility of P300/P300' event-related potential (ERP) component amplitude (microV) during the Hold-Release (HR) neuropsychological test
Time frame: through study completion, an average of 14 months
Reproducibility of P300/P300' will be assessed by Interclass Coefficient Correlation (ICC)
Intra-individual variability of P300/P300' event-related potential (ERP) component amplitude (microV) during the Hold-Release (HR) neuropsychological test
Time frame: through study completion, an average of 14 months
Intra-individual variability of P300/P300' will be assessed by Interclass Coefficient Correlation (ICC)
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
Time frame: through study completion, an average of 14 months
the statistical model of repeated measurements of variance analysis will be used
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
Time frame: through study completion, an average of 14 months
the statistical model of repeated measurements of variance analysis will be used
11 secondary outcomes
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
Time frame: 6 months
Change in scores of categorical semantic verbal fluency after 6 months of Ginkgo biloba treatment
Time frame: 6 months
Change in scores of verbal fluency letter instruction after 6 months of Ginkgo biloba treatment
Time frame: 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
Time frame: 6 months
Change in reaction time (ms) during the Hold-Release (HR) neuropsychological test after 6 months of Ginkgo biloba treatment
Time frame: 6 months
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.
Time frame: through study completion, an average of 14 months
Magnitude of repetition effects (Test-retest Reliability, TTR) on P300/P300' event-related potential (ERP) component during the Hold-Release (HR) neuropsychological test.
Time frame: through study completion, an average of 14 months
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.
Time frame: through study completion, an average of 14 months
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.
Time frame: through study completion, an average of 14 months
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
Time frame: through study completion, an average of 14 months
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
Time frame: through study completion, an average of 14 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
- Background: PubMed 19067364Amieva 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.
- Background: PubMed 25201166Luck 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.
- Background: PubMed 9811557Thierry 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.
- Background: PubMed 20361039Martin 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.
- Background: PubMed 25114079Tan 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.
- Background: PubMed 12895688Kennedy 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-François Démonet, Prof principal investigator
Universitary Lausanne Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ginkgo biloba extract in people with Subjective Cognitive Decline and Cognitive Performance, run by Jean-François Démonet at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reproducibility of contingent negative variation (CNV) event-related potential (ERP) component amplitude (microV) during the Hold-Release (HR) neuropsychological test (time frame: through study completion, an average of 14 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04121728, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2023.