Effects of Ginkgo Biloba on Blood Biomarkers in Mild Cognitive Impairment
Effect of Gingko Biloba on the Blood Biomarkers in Mild Cognitive Impairment Patients With Alzheimer's Disease
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
Ginkgo biloba has been widely used for cognitive impairment and is suggested to exert neuroprotective effects through antioxidant, anti-inflammatory, and anti-amyloid mechanisms. However, its effects on Alzheimer's disease-related blood biomarkers remain unclear. Alzheimer's disease is characterized by amyloid and tau pathology, which can be partially reflected by plasma p-tau217, while neurofilament light (NfL) reflects neuroaxonal injury.
This is a multicenter, randomized, double-blind, placebo-controlled study conducted in patients with mild cognitive impairment due to Alzheimer's disease. Participants will be assigned in a 1:1 ratio to receive either Ginkgo biloba 240 mg or placebo once daily for 6 months.
The study aims to evaluate whether Ginkgo biloba administration affects these blood biomarkers (p-tau217, NfL) and whether changes in biomarkers are associated with cognitive outcomes measured by the Clinical Dementia Rating-Sum of Boxes (CDR-SB). By analyzing these relationships, this research seeks to explore the potential disease-modifying effects of Ginkgo biloba.
Studietype
Inschrijving (Geschat)
Fase
- Fase 4
Contacten en locaties
Studiecontact
- Naam: Seong-Ho Koh, MD, PhD
- Telefoonnummer: +82-31-560-2264
- E-mail: 2057069@hyumc.com
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- Age 20 years or older
- Clinical Dementia Rating (CDR) score of 0.5
- Patients clinically indicated for treatment with Ginkgo biloba extract
Exclusion Criteria:
- 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.
- Pregnant women.
- Genetic conditions associated with lactose intolerance, including galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
- Presence of bleeding disorders at screening, or requirement for continuous use of medications that may affect study drug efficacy (e.g., anticoagulants, antiplatelets, thrombolytics, peripheral vasodilators, PGE1 and its derivatives).
- Any condition that, in the opinion of the investigator or study staff, makes the participant unsuitable for the study or unable to comply with study procedures.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Ginkgo Biloba 240 mg
Participants in the experimental group will receive a 240 mg Ginkgo biloba extract tablet orally once daily for 6 months.
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The intervention consists of Ginkgo biloba extract administered as a 240 mg film-coated tablet.
Participants take one tablet orally once daily for 6 months.
Andere namen:
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Sham-vergelijker: Placebo
Participants in the placebo group will receive a placebo tablet, identical in appearance to the Ginkgo biloba tablet, orally once daily for 6 months.
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A placebo tablet identical in appearance to the Ginkgo biloba tablet.
Participants take one tablet orally once daily for 6 months.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change from Baseline in Plasma p-tau217 at 6 Months
Tijdsspanne: Baseline, 6 months
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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.
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Baseline, 6 months
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
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Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- GURI 2026-04-016-001
- U1111-1342-9252 (Register-ID: WHO)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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