A Pilot Study to Examine the Effect of Egb761 on Plasma Biomarker Levels and on Cognitive Function in Patients With MCI

NCT07287852 | Enrolling By Invitation Phase 2

• 1 other identifier: 0658-22-HMO
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Alzheimer Disease (AD); Mild Cognitive Impairment (MCI)

Keywords

mild cognitive impairment; phosphorylated Tau; ginkgo biloba

Outcome Measures

Primary Outcomes (1)

• 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

  Plasma biomarker level tested at recruitment, at 3 and 6-months of trial

Secondary Outcomes (6)

• Symptomatic effect

  The test will be performed at recruitment, at 3- and 6-months of treatment

• Symptomatic effect

  The test will be performed at recruitment, at 3- and 6-months of treatment

• Symptomatic effect

  The test will be performed at recruitment, at 3- and 6-months of treatment

• Symptomatic effect

  The test will be performed at recruitment, at 3- and 6-months of treatment

• Change in plasma GFAP level

  Plasma biomarker will be determined at recruitment and at 3- and 6-months

Study Arms (1)

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.

Dietary Supplement: Ginkgo Biloba Extract 761

Interventions

Ginkgo Biloba Extract 761 DIETARY_SUPPLEMENT

Each participant will receive two 120mg Egb761 pills per day along the 6 month trial

A single arm trial, where all participants will receive the studied medication

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Mild cognitive impairment, as defined by MoCA score of 19-25.
• Preserved instrumental activities of daily life (iADL).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah medical Center

Jerusalem, 91120, Israel

Location

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Interventions

Ginkgo biloba extract

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 29, 2025
• First Posted: December 17, 2025
• Study Start: August 20, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-06

Locations

IL (1)