Alzheimer's Disease, Mild Cognitive Impairment
Conditions
Keywords
Mild Cognitive Impairment, Ginexin, Alzheimer's Disease, Ginkgo Biloba Extract
Brief summary
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.
Detailed description
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.
Interventions
DRUGGinkgo Biloba Extract 240 mg
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.
DRUGPlacebo
A placebo tablet identical in appearance to the Ginkgo biloba tablet. Participants take one tablet orally once daily for 6 months.
Sponsors
Hanyang University
SK Chemicals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Participants are randomly assigned in a 1:1 ratio to either the Ginkgo Biloba 240 mg group or the placebo group. Randomization is performed using a computer-generated random sequence of permutations, applied sequentially from the first enrolled subject, with a block randomization method using randomly varying block sizes. Stratification by clinical site is applied to ensure balanced allocation across study sites. The randomization list is generated by an independent individual not otherwise involved in the study
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Plasma p-tau217 at 6 Months | Baseline, 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. |
Contacts
CONTACTSeong-Ho Koh, MD, PhD
Outcome results
None listed