EGb 761 in the Syndrome of MCI With Concomitant CVD

November 14, 2022 updated by: National Neuroscience Institute

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

134

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Singapore
      • Singapore, Singapore, 308433
        • Recruiting
        • National Neuroscience Institute
        • Contact:
        • Principal Investigator:
          • Nagaendran Kandiah, MRCP;FAMS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

41 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who have been diagnosed with MCI based on the Petersen criteria and Albert MS criteria
  • 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 the opinion of the investigators
  • Patients with the presence of CVD, defined as the presence of white matter hyperintensities (WMH) of Fazekas grade 2 or 3 on MRI brain imaging (done up to 12 months prior to recruitment) or CT scans for patients contraindicated from MRI scans
  • Patients who provide written informed consent to participate in the study

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 of Product Characteristics (SmPC) should be observed.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tebonin Forte
Treatment: 120mg, twice a day, 52 weeks
Drug: Tebonin Forte
Dietary supplement: Gingko biloba EGb 761
No Intervention: Control
No Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alzheimer's Disease Assessment Scale-Cognitive 13 (ADAS-Cog 13)
Time Frame: 52 weeks
Cognitive assessment
52 weeks
Clinical Dementia Rating Sum of Boxes Scores (CDR-SOB)
Time Frame: 52 weeks
Functional assessment
52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Cognitive Assessment Tool (VCAT)
Time Frame: 52 weeks
Cognitive assessment
52 weeks
Mild Behavioural Impairment Checklist (MBI-C)
Time Frame: 52 weeks
Behavioral assessment
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Neuroscience Institute

Collaborators

Dr. Willmar Schwabe GmbH & Co. KG

Investigators

  • Principal Investigator: Kok Pin Ng, National Neuroscience Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 26, 2020

Primary Completion (Anticipated)

December 1, 2025

Study Completion (Anticipated)

November 1, 2026

Study Registration Dates

First Submitted

August 20, 2020

First Submitted That Met QC Criteria

August 20, 2020

First Posted (Actual)

August 25, 2020

Study Record Updates

Last Update Posted (Actual)

November 17, 2022

Last Update Submitted That Met QC Criteria

November 14, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EGB-MCI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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