EGb 761 in the Syndrome of MCI With Concomitant CVD

Mild Cognitive Impairment Clinical Trial

Official title: Evaluating the Role of EGb 761 in the Syndrome of Mild Cognitive Impairment With Concomitant Cerebrovascular Disease (MCI + CVD)

Status Recruiting

Clinical Trial Summary

EGb 761 has been demonstrated to be useful in improving cognitive and global clinical outcomes in patients with cognitive impairment or dementia, when administered at a daily dosage of 240mg in randomised controlled trials through several neuroprotective mechanisms of action. The study aims to determine the efficacy and safety profile of EGb 761 as a prescribed clinical drug for patients with MCI + CVD.

Clinical Trial Description

EGb 761 has been demonstrated to be useful in improving cognitive and global clinical outcomes in patients with cognitive impairment or dementia, when administered at a daily dosage of 240 mg in randomised controlled trials through several neuroprotective mechanisms of action.

The study aims to determine the efficacy and safety profile of EGb 761 as a prescribed clinical drug for patients with MCI + CVD. This study is an open label 52-weeks study in subjects who have both MCI (based on the Petersen criteria and Albert MS criteria) and CVD. Eligibility for enrolment will be assessed initially at a screening visit, which is to occur within 42 days of baseline. 134 male and female subjects will participate and 67 of the 134 will receive the drug.

Subjects will be randomized to the EGB 761 arm and control arm in a 1:1 ratio using a block randomization method in groups of 4 subjects using an automated randomization software. The study will allow generating data in an Asian and multi-racial population and allows physicians to offer clinically efficacious and alternative treatment for patients with MCI + CVD. ;

Related Conditions & MeSH terms

• Cerebrovascular Disease
• Cerebrovascular Disorders
• Cognitive Dysfunction
• Mild Cognitive Impairment

• NCT number: NCT04525144
• Study type: Interventional
• Source: National Neuroscience Institute
• Contact: Joanna Wang
• Phone: (65) 6357 7635
• Email: joanna.wang.s@singhealth.com.sg
• Status: Recruiting
• Phase: Phase 2
• Start date: October 26, 2020
• Completion date: November 2026