NCT04525144 EGb 761 in the Syndrome of MCI With Concomitant CVD
| NCT ID | NCT04525144 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | National Neuroscience Institute |
| Condition | Mild Cognitive Impairment |
| Study Type | INTERVENTIONAL |
| Enrollment | 134 participants |
| Start Date | 2020-10-26 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 134 participants in total. It began in 2020-10-26 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Kok Pin Ng
PRINCIPAL INVESTIGATOR
National Neuroscience Institute
Frequently Asked Questions
Who can join the NCT04525144 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 85 Years, studying Mild Cognitive Impairment. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04525144 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04525144 currently recruiting?
Yes, NCT04525144 is actively recruiting participants. Contact the research team at joanna.wang.s@singhealth.com.sg for enrollment information.
Where is the NCT04525144 trial being conducted?
This trial is being conducted at Singapore, Singapore.
Who is sponsoring the NCT04525144 clinical trial?
NCT04525144 is sponsored by National Neuroscience Institute. The principal investigator is Kok Pin Ng at National Neuroscience Institute. The trial plans to enroll 134 participants.