EGb 761 for Mild Cognitive Impairment with Cerebrovascular Disease
Evaluating the Role of EGb 761 in the Syndrome of Mild Cognitive Impairment With Concomitant Cerebrovascular Disease (MCI + CVD)
This study is testing if a herbal extract called EGb 761 can help people with Mild Cognitive Impairment and Cerebrovascular Disease improve their thinking and memory over a year.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 134 (estimated) |
| Ages | 45 Years to 85 Years |
| Sex | All |
| Sponsor | National Neuroscience Institute Academic / other |
| Locations | 1 site (Singapore) |
| Trial ID | NCT04525144 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of EGb 761, a herbal extract, in patients diagnosed with Mild Cognitive Impairment (MCI) who also have Cerebrovascular Disease (CVD). It is an open-label, 52-week trial involving 134 participants, where half will receive the treatment and the other half will serve as a control group. Participants will be assessed based on specific diagnostic criteria and will undergo cognitive evaluations throughout the study. The aim is to provide an alternative treatment option for this patient population by leveraging the neuroprotective properties of EGb 761.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 45 to 85 diagnosed with MCI and CVD, who meet specific cognitive and imaging criteria.
Not a fit: Patients currently taking antidepressants, antipsychotics, or other specified medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve cognitive function and overall clinical outcomes for patients with MCI and CVD.
How similar studies have performed: Previous studies have shown positive outcomes with EGb 761 in cognitive impairment, suggesting potential for success in this specific population.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Singapore
- National Neuroscience Institute — Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: Kok Pin Ng — National Neuroscience Institute
- Study coordinator: Joanna Wang
- Email: joanna.wang.s@singhealth.com.sg
- Phone: (65) 6357 7635
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.