Effects of Ginkgo Biloba on Blood Biomarkers in Mild Cognitive Impairment
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age20+
SponsorHanyang University
About this trial
This study evaluates the effects of Ginkgo biloba on blood biomarkers related to Alzheimer's disease in patients with mild cognitive impairment. Participants will be randomly assigned to receive either Ginkgo biloba or a placebo for 6 months. Changes in blood biomarkers, including p-tau217 and neurofilament light (NfL), as well as cognitive function, will be assessed to determine whether Ginkgo biloba may influence disease-related biological processes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 20 years or older
Clinical Dementia Rating (CDR) score of 0.5
Patients clinically indicated for treatment with Ginkgo biloba extract
Disqualifiers
Current use of cholinesterase inhibitors such as donepezil, rivastigmine, or galantamine.
Refusal to provide informed consent.
Presence of neurological or psychiatric conditions other than Alzheimer's disease that may affect cognitive function.
Known hypersensitivity to Ginkgo biloba extract or any of its components.
Trial design
Design model
Parallel
Treatments tested in this trial
Ginkgo Biloba Extract 240 mg
DrugThe intervention consists of Ginkgo biloba extract administered as a 240 mg film-coated tablet. Participants take one tablet orally once daily for 6 months.
Placebo
DrugA placebo tablet identical in appearance to the Ginkgo biloba tablet. Participants take one tablet orally once daily for 6 months.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Ginkgo Biloba 240 mgExperimental treatment 1 intervention
Group B: PlaceboSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from Baseline in Plasma p-tau217 at 6 Months
Plasma p-tau217 levels will be measured using a validated blood assay at baseline and 6 months after treatment. The concentration of p-tau217 will be used as a biomarker of Alzheimer's disease-related pathology, and changes from baseline will be assessed following administration of Ginkgo biloba extract.
Time frame
Baseline, 6 monthsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Hanyang University
Lead sponsor
SK Chemicals
Collaborator
Source ClinicalTrials.gov
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