Alzheimer Disease (AD)Phase 2NCT07287852
A Pilot Study to Examine the Effect of Egb761 on Plasma Biomarker Levels and on Cognitive Function in Patients With MCI
A Phase 2 study testing Ginkgo Biloba Extract 761 in people with Alzheimer Disease (AD) and Mild Cognitive Impairment (MCI), run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The goal of this clinical trial is to learn if the drug Egb761, produced from Ginkgo Biloba extract, works to improve the blood level of a biomarker of Alzheimer's disease, called phosphorylated-tau217 (p-tau217), which serves as a biomarker for disease activity in the brain. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Alzheimer Disease (AD), Mild Cognitive Impairment (MCI)
- What is being tested?
- Ginkgo Biloba Extract 761
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- 20 Aug 2024to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Mild cognitive impairment, as defined by MoCA score of 19-25.
- Preserved instrumental activities of daily life (iADL).
- Clinical impression of MCI of AD type, and lack of major medical and neurological conditions, as detailed in the exclusion criteria.
Who cannot join
- Extrapyramidal signs, existence of multi-infract dementia, or Fronto-Temporal dementia, according to clinical impression by treating cognitive Neurologist.
- Active cancer, severe cardio-pulmonary disease or other medical condition which negatively affects ability to evaluate patients and complete follow-up.
- Inability to sign an informed consent due to psychiatric or dementing condition.
- Hypersensitivity to any ingredient of the study medication.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Is Cerebonin (Egb761) a Disease-modifying Therapy in Mild Cognitive Impairment
The goal of this clinical trial is to learn if the drug Egb761, produced from Ginkgo Biloba extract, works to improve the blood level of a biomarker of Alzheimer's disease, called phosphorylated-tau217 (p-tau217), which serves as a biomarker for disease activity in the brain. The main questions it aims to answer are:
Does drug Egb761 lower the plasma level of p-tau217 in patients with mild cognitive impairment? Does drug Egb761 improve cognitive and behavioral functions in these patients? Does Egb761 affect the blood levels of neurofilament-light (Nfl) and glial-fibrillary-acidic-protein (GFAP), which serve as additional biomarkers for brain disease activity?
Read more
Participants will:
Take Egb761 twice daily for 6 months Visit the clinic once every 3 months for checkups and tests Keep a diary of their symptoms
Read the detailed description
Participating center: A single-center trial performed at Hadassah - Hebrew University Medical Center in Jerusalem, Israel. The investigators have vast experience in performing full medical and neuropsychological evaluations, and in performing clinical trials in patients with cognitive decline. Patients will be recruited via the cognitive Neurology clinics at the Hadassah Ein-Kerem campus, Hadassah Mount Scopus campus, and Merhav out-patient clinic for cognitive Neurology, which is associated and operated by Hadassah Neurologists.
Patient recruitment: 50 patients with mild cognitive impairment (MCI) will be recruited, according to its accepted definition. Patients with MCI will undergo standard evaluation, including brain imaging (MRI / CT), thyroid function tests, Vitamin B12, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) to rule out other causes of cognitive decline.
The investigators expect that approximately 70% of recruited patients will display increased plasma p-tau217 level, indicating MCI of Alzheimer's type.
Clinical and neuropsychological evaluation will include: (1) Full demographic data (age, gender, education level and occupation, family status, ethnicity and country of origin); (2) Clinical data on risk factors (metabolic/ cardiovascular risk factors - heart disease, diabetes, hypertension, hyperlipidemia; Infectious/ inflammatory risk factors - periodontal disease, systemic infections, systemic inflammatory conditions; Lifestyle factors - smoking, alcohol consumption, sleeping disorder, physical activity; and Mental factors - anxiety and depression, cognitive activity); (3) MoCA (in Hebrew version); (4) Mild Behavioral Impairment checklist (MBI-C), or Neuropsychiatric Inventory (NPI) questionnaire (in Hebrew version); (5) ADL and iADL questionnaire; (6)Trail making test -B (TMT-B); Word fluency test.
Determination of blood biomarkers: Venous blood will be drawn upon recruitment in a tube containing EDTA to prevent clotting. The blood will be centrifuged at 1200 rpm for 5 minutes, and plasma stored in -80°C, within two hours of drawing the blood sample. The samples will be stored in a temperature-controlled and monitored freezer, until delivery in dry ice to the central lab (Prof. Ben-Hur's lab at the Ein-Kerem campus) for determination of biomarkers. Blood samples that were collected at recruitment will be tested for p-tau217 level, neurofilament light and GFAP. The baseline p-tau217 will serve as a reference value for monitoring individual response to therapy, as well as the group trend in the other biomarkers.
Treatment: All patients will receive Cerebonin (Egb761) 240mg per day, by tablets of 120mg, taken twice daily.
Follow-up: After initiation of treatment, patients will be invited for follow-up visits at 3 months and 6 months. Clinical data (risk factor assessment), MoCA, MBI-C, iADL and plasma p-tau217 level will be evaluated in each visit. The investigators will evaluate total MoCA score, as well as its breakdown into cognitive domains (attention, executive, memory (both free and cued / recognition recall), visuospatial, language, and orientation). One point is added if the subject has ≤12 years of education.
Evaluating response to therapy: (1) In patients with high baseline plasma p-tau181 level, the investigators will compare pre- and post-treatment plasma p-tau-217 levels (Δp-tau). Since plasma p-tau217 is considered a biomarker of active brain disease, a reduction in its level will suggest a disease-modifying therapeutic effect; (2) The investigators will examine the trend in group averages of neurofilament and GFAP, as additional disease biomarkers. (3) The investigators will determine the symptomatic clinical response according to improvement in MoCA, MBI-C/NPI, TMT-B and ADL/iADL scores after 3 and 6 months of treatment; (4) The investigators will compare the treatment effect in MCI patients with high- versus normal- plasma p-tau217 levels (eg. in MCI of AD type versus non-AD type); (5) The investigators will examine the association between clinical improvement and change in the plasma level of biomarkers.
- Being tested
- Ginkgo Biloba Extract 761
- Keywords
- mild cognitive impairment, phosphorylated Tau, ginkgo biloba
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ginkgo Biloba Extract 761Dietary supplement
Each participant will receive two 120mg Egb761 pills per day along the 6 month trial
| Study group | Role | What they receive |
|---|---|---|
| A single arm trial, where all participants will receive the studied medication | Experimental | In this single arm trial, the post-treatment biomarkers levels will be compared to pre-treatment levels per participant, with each participant's pre-treatment biomarkers' levels serving as baseline for reference. Receives: Dietary Supplement: Ginkgo Biloba Extract 761 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma phosphorylated-tau level
Change in post-treatment plasma phosphorylated Tau level (6 months time point) as compared to pre-treatment level. P-tau level is reported in pg/ml
Measured: Plasma biomarker level tested at recruitment, at 3 and 6-months of trial
Secondary outcomes (6)
Symptomatic effect
Change between pre-treatment and post-treatment (6 months time point) MoCA scores. MoCA score range is between 0-30.
Measured: The test will be performed at recruitment, at 3- and 6-months of treatment
Symptomatic effect
Change between pre-treatment and post-treatment (6months time point) in TMT-B scores. TMT-B is measured as time (number of seconds) to complete the task.
Measured: The test will be performed at recruitment, at 3- and 6-months of treatment
Symptomatic effect
Change between pre-treatment and post-treatment (6months time point) in word fluency score. Word fluency score is the number of words generated in the 1-minute timed test.
Measured: The test will be performed at recruitment, at 3- and 6-months of treatment
Symptomatic effect
Change between pre-treatment and post-treatment (6 months time point) in the neuropsychiatric questionnaire score. The MBI-C questionnaire score range is 0-102.
Measured: The test will be performed at recruitment, at 3- and 6-months of treatment
Change in plasma GFAP level
Change in post-treatment plasma GFAP level (6 months time point) as compared to pre-treatment level. GFAP level is reported in pg/ml.
Measured: Plasma biomarker will be determined at recruitment and at 3- and 6-months
Change in plasma neurofilament-light level
Change in post-treatment plasma neurofilament-light level (6 months time point) as compared to pre-treatment level. Nfl level is reported in pg/ml
Measured: Plasma biomarker will be determined at recruitment and at 3- and 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start20 Aug 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer Disease (AD)Studies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- In this trial, all participants will be treated with Egb761. The investigators will evaluate plasma levels of phosphorylated Tau, cognitive performance and degree of behavioral impairment before treatment, and after 3 and 6 months of treatment. The change between pre-treatment plasma level of phosphorylated Tau versus post-treatment level, as well as change in cognitive and behavioral evaluations will be analyzed in each participant, to determine whether Egb761 induces an improvement in phosphorylated Tau level and whether it causes symptomatic relief.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07287852
- Sponsor's protocol ID
- 0658-22-HMO
- Status last verified
- Jun 2025
- First submitted
- 29 Jun 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We plan to share IPD on cognitive, behavioral, and biomarker data without personal identification, as required by the IRB upon completion of the trial.
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Cerebonin (Egb761) a Disease-modifying Therapy in Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT07287852
- Acronym / sponsor ID
- 0658-22-HMO
- Keywords
- mild cognitive impairment, phosphorylated Tau, ginkgo biloba
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 Dec 2025 (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 goal of this clinical trial is to learn if the drug Egb761, produced from Ginkgo Biloba extract, works to improve the blood level of a biomarker of Alzheimer's disease, called phosphorylated-tau217 (p-tau217), which serves as a biomarker for disease activity in the brain. The main questions it aims to answer are:
Does drug Egb761 lower the plasma level of p-tau217 in patients with mild cognitive impairment? Does drug Egb761 improve cognitive and behavioral functions in these patients? Does Egb761 affect the blood levels of neurofilament-light (Nfl) and glial-fibrillary-acidic-protein (GFAP), which serve as additional biomarkers for brain disease activity?
Participants will:
Take Egb761 twice daily for 6 months Visit the clinic once every 3 months for checkups and tests Keep a diary of their symptoms
Detailed description
Participating center: A single-center trial performed at Hadassah - Hebrew University Medical Center in Jerusalem, Israel. The investigators have vast experience in performing full medical and neuropsychological evaluations, and in performing clinical trials in patients with cognitive decline. Patients will be recruited via the cognitive Neurology clinics at the Hadassah Ein-Kerem campus, Hadassah Mount Scopus campus, and Merhav out-patient clinic for cognitive Neurology, which is associated and operated by Hadassah Neurologists.
Patient recruitment: 50 patients with mild cognitive impairment (MCI) will be recruited, according to its accepted definition. Patients with MCI will undergo standard evaluation, including brain imaging (MRI / CT), thyroid function tests, Vitamin B12, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) to rule out other causes of cognitive decline.
The investigators expect that approximately 70% of recruited patients will display increased plasma p-tau217 level, indicating MCI of Alzheimer's type.
Clinical and neuropsychological evaluation will include: (1) Full demographic data (age, gender, education level and occupation, family status, ethnicity and country of origin); (2) Clinical data on risk factors (metabolic/ cardiovascular risk factors - heart disease, diabetes, hypertension, hyperlipidemia; Infectious/ inflammatory risk factors - periodontal disease, systemic infections, systemic inflammatory conditions; Lifestyle factors - smoking, alcohol consumption, sleeping disorder, physical activity; and Mental factors - anxiety and depression, cognitive activity); (3) MoCA (in Hebrew version); (4) Mild Behavioral Impairment checklist (MBI-C), or Neuropsychiatric Inventory (NPI) questionnaire (in Hebrew version); (5) ADL and iADL questionnaire; (6)Trail making test -B (TMT-B); Word fluency test.
Determination of blood biomarkers: Venous blood will be drawn upon recruitment in a tube containing EDTA to prevent clotting. The blood will be centrifuged at 1200 rpm for 5 minutes, and plasma stored in -80°C, within two hours of drawing the blood sample. The samples will be stored in a temperature-controlled and monitored freezer, until delivery in dry ice to the central lab (Prof. Ben-Hur's lab at the Ein-Kerem campus) for determination of biomarkers. Blood samples that were collected at recruitment will be tested for p-tau217 level, neurofilament light and GFAP. The baseline p-tau217 will serve as a reference value for monitoring individual response to therapy, as well as the group trend in the other biomarkers.
Treatment: All patients will receive Cerebonin (Egb761) 240mg per day, by tablets of 120mg, taken twice daily.
Follow-up: After initiation of treatment, patients will be invited for follow-up visits at 3 months and 6 months. Clinical data (risk factor assessment), MoCA, MBI-C, iADL and plasma p-tau217 level will be evaluated in each visit. The investigators will evaluate total MoCA score, as well as its breakdown into cognitive domains (attention, executive, memory (both free and cued / recognition recall), visuospatial, language, and orientation). One point is added if the subject has ≤12 years of education.
Evaluating response to therapy: (1) In patients with high baseline plasma p-tau181 level, the investigators will compare pre- and post-treatment plasma p-tau-217 levels (Δp-tau). Since plasma p-tau217 is considered a biomarker of active brain disease, a reduction in its level will suggest a disease-modifying therapeutic effect; (2) The investigators will examine the trend in group averages of neurofilament and GFAP, as additional disease biomarkers. (3) The investigators will determine the symptomatic clinical response according to improvement in MoCA, MBI-C/NPI, TMT-B and ADL/iADL scores after 3 and 6 months of treatment; (4) The investigators will compare the treatment effect in MCI patients with high- versus normal- plasma p-tau217 levels (eg. in MCI of AD type versus non-AD type); (5) The investigators will examine the association between clinical improvement and change in the plasma level of biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- In this trial, all participants will be treated with Egb761. The investigators will evaluate plasma levels of phosphorylated Tau, cognitive performance and degree of behavioral impairment before treatment, and after 3 and 6 months of treatment. The change between pre-treatment plasma level of phosphorylated Tau versus post-treatment level, as well as change in cognitive and behavioral evaluations will be analyzed in each participant, to determine whether Egb761 induces an improvement in phosphorylated Tau level and whether it causes symptomatic relief.
| Arm | Type | Receives |
|---|---|---|
| A single arm trial, where all participants will receive the studied medication | Experimental | Dietary Supplement: Ginkgo Biloba Extract 761In this single arm trial, the post-treatment biomarkers levels will be compared to pre-treatment levels per participant, with each participant's pre-treatment biomarkers' levels serving as baseline for reference. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Mild cognitive impairment, as defined by MoCA score of 19-25.
- Preserved instrumental activities of daily life (iADL).
- Clinical impression of MCI of AD type, and lack of major medical and neurological conditions, as detailed in the exclusion criteria.
Key exclusion criteria (4 listed)
- Extrapyramidal signs, existence of multi-infract dementia, or Fronto-Temporal dementia, according to clinical impression by treating cognitive Neurologist.
- Active cancer, severe cardio-pulmonary disease or other medical condition which negatively affects ability to evaluate patients and complete follow-up.
- Inability to sign an informed consent due to psychiatric or dementing condition.
- Hypersensitivity to any ingredient of the study medication.
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 Extract 761Each participant will receive two 120mg Egb761 pills per day along the 6 month trial | Dietary supplement | A single arm trial, where all participants will receive the studied medication |
Primary outcome
Change in plasma phosphorylated-tau level
Time frame: Plasma biomarker level tested at recruitment, at 3 and 6-months of trial
Change in post-treatment plasma phosphorylated Tau level (6 months time point) as compared to pre-treatment level. P-tau level is reported in pg/ml
6 secondary outcomes
Symptomatic effect
Time frame: The test will be performed at recruitment, at 3- and 6-months of treatment
Symptomatic effect
Time frame: The test will be performed at recruitment, at 3- and 6-months of treatment
Symptomatic effect
Time frame: The test will be performed at recruitment, at 3- and 6-months of treatment
Symptomatic effect
Time frame: The test will be performed at recruitment, at 3- and 6-months of treatment
Change in plasma GFAP level
Time frame: Plasma biomarker will be determined at recruitment and at 3- and 6-months
Change in plasma neurofilament-light level
Time frame: Plasma biomarker will be determined at recruitment and at 3- and 6-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: Undecided. We plan to share IPD on cognitive, behavioral, and biomarker data without personal identification, as required by the IRB upon completion of the trial.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ginkgo Biloba Extract 761 in people with Alzheimer Disease (AD) and Mild Cognitive Impairment (MCI), run by Hadassah Medical Organization at 1 site in Israel.
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 3 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 17 Dec 2025. 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 Israel. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Change in plasma phosphorylated-tau level (time frame: Plasma biomarker level tested at recruitment, at 3 and 6-months of trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Dec 2025.