NCT04492241

Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution for the Treatment of Motoric Cognitive Risk Syndrome

Evaluation of Efficacy and Safety of Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution for the Treatment of Motoric Cognitive Risk Syndrome: A Multi-centre, Randomised, Double Blind and Placebo-controlled Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 60 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-centre, randomised, double blind, placebo controlled study on participants with Motoric Cognitive Risk Syndrome to evaluate the efficacy and safety of Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution.

Detailed description

Cognition and locomotion are two human abilities controlled by the brain. Their decline is highly prevalent with aging, and is greater than the simple sum of their respective prevalence, suggesting a complex age-related interplay between cognition and locomotion. Recently, a systematic review and meta-analysis has provided evidence that poor gait performance predicts dementia and, in particular, has demonstrated that "motoric cognitive risk" (MCR) syndrome, which has been described in cognitively healthy individuals and combines subjective cognitive complaint with objective slow gait speed, is a pre-dementia syndrome. MCR as a relatively new recognised clinical syndrome is with a high prevalence calculated around 10% in world population aged 60 and above. MCR syndrome predicts mild and major neurocognitive disorders. MCR syndrome does not rely on a complex and time-consuming assessment, making it applicable to the aging population. Thus, MCR syndrome seems to be a good syndrome to identify individuals at risk of mild and major neurocognitive disorders in any type of healthcare setting. Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution has proven efficacy for cognitive function deterioration in preliminary studies. The aim of this study is to evaluate its efficacy and safety for MCR.

Conditions

• Motoric Cognitive Risk Syndrome
• Mild Cognitive Impairment
• Aging
• Locomotive Syndrome

Interventions

Type	Name	Description
DRUG	Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution	TID for 6 month after enrolment Glass oral bottle, 10 ml/bottle. Study Arm Component: Ginkgo Leaf Extract and Armillariella Mellea Powder, konjac (sweetener), purified water.
DRUG	Simulation of Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution	TID for 6 month after enrolment Glass oral bottle, 10 ml/bottle. Placebo Arm Component: Caramel color (food color), konjac (sweetener), sucrose octaacetate (food additive), sodium benzoate (food additive), purified water.

Timeline

• Start date: 2021-07-05
• Primary completion: 2023-12-31
• Completion: 2024-12-31
• First posted: 2020-07-30
• Last updated: 2021-12-09

Locations

1 site across 1 country: China