EGb 761 in the Syndrome of MCI With Concomitant CVD

Last updated: November 14, 2022
Sponsor: National Neuroscience Institute
Overall Status: Active - Recruiting

Phase

2

Condition

Stroke

Atherosclerosis

Mild Cognitive Impairment

Treatment

N/A

Clinical Study ID

NCT04525144
EGB-MCI
  • Ages 45-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients who have been diagnosed with MCI based on the Petersen criteria and Albert MScriteria
  • Patients who have a Global Clinical Dementia Rating Score of 0.5
  • Patients aged 45 to 85 years at study entry
  • Patients who are literate and able to complete the cognitive evaluations in theopinion of the investigators
  • Patients with the presence of CVD, defined as the presence of white matterhyperintensities (WMH) of Fazekas grade 2 or 3 on MRI brain imaging (done up to 12months prior to recruitment) or CT scans for patients contraindicated from MRI scans
  • Patients who provide written informed consent to participate in the study

Exclusion

Exclusion Criteria:

  • Participants should not be receiving antidepressants, antipsychotics, benzodiazepines,acetylcholinesterase inhibitors or NMDA antagonists during the study. Additionally,contraindications for EGb 761 as given in the local prescribing information/Summary ofProduct Characteristics (SmPC) should be observed.

Study Design

Total Participants: 134
Study Start date:
October 26, 2020
Estimated Completion Date:
November 30, 2026

Study 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.

Connect with a study center

  • National Neuroscience Institute

    Singapore, 308433
    Singapore

    Active - Recruiting

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