NCT06495476

Study on Ginkgo Biolba Extract Fifty and Mild Cognitive Impairment Associated With CSVD

Study on Ginkgo Biolba Extract Fifty in the Treatment of Mild Cognitive Impairment Associated With Cerebral Small Vessel Disease

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study aimed to explore the efficacy and safety of Ginkgo Biolba Extract fifty in treating mild cognitive impairment associated with cerebral small vessel disease (CSVD). Subjects included based on eligibility criteria were randomized into treatment and control groups. Patients will receive the drug or placebo for 12 months. Patients were followed at baseline and at 3 months, 6 months, and 12 months after randomization. The primary outcome was the difference from baseline in the Montreal Cognitive Assessmen (MoCA) score at 12 months after randomization.

Conditions

• Mild Cognitive Impairment

Interventions

Type	Name	Description
DRUG	Ginkgo biloba extract 50 dropping pills	Composition: Ginkgo ketone ester, excipient polyethylene glycol 6000. Size: 10mg ginkgolides/pill.
DRUG	Ginkgo biloba extract Ginkgo biloba extract 50 Drops simulant	Composition: The main ingredient is polyethylene glycol 6000 + caramel pigment, placebo and ginkgolide drops are basically the same in color, odor and appearance. Size: 10 mg analog ingredient/pill.

Timeline

• Start date: 2024-09-01
• Primary completion: 2025-12-31
• Completion: 2026-06-30
• First posted: 2024-07-10
• Last updated: 2024-08-28