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

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

Interventions

• Ginkgo Biloba Extract 761 · DIETARY_SUPPLEMENT

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

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Sites (1)

• Hadassah medical Center, Jerusalem, Israel