EGb 761 in the Syndrome of MCI With Concomitant CVD

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Mild Cognitive Impairment, Cerebrovascular Disease

Intervention / Treatment
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* Drug: Tebonin Forte


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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