Cerebrovascular Disease, Mild Cognitive Impairment
Conditions
Brief 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.
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.
Interventions
DRUGTebonin Forte
Dietary supplement: Gingko biloba EGb 761
Sponsors
Dr. Willmar Schwabe GmbH & Co. KG
National Neuroscience Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alzheimer's Disease Assessment Scale-Cognitive 13 (ADAS-Cog 13) | 52 weeks | Cognitive assessment |
| Clinical Dementia Rating Sum of Boxes Scores (CDR-SOB) | 52 weeks | Functional assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Cognitive Assessment Tool (VCAT) | 52 weeks | Cognitive assessment |
| Mild Behavioural Impairment Checklist (MBI-C) | 52 weeks | Behavioral assessment |
Countries
Singapore
Contacts
Primary ContactJoanna Wang
Outcome results
None listed