EGb 761 in the Syndrome of MCI With Concomitant CVD

Launched by NATIONAL NEUROSCIENCE INSTITUTE · Aug 20, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a medication called EGb 761 to see if it can help improve memory and thinking skills in people who have mild cognitive impairment (MCI) along with cerebrovascular disease (CVD). MCI is a condition that can lead to more serious memory problems, and CVD refers to issues related to blood flow in the brain. The researchers will give participants 240 mg of EGb 761 daily and monitor how well it works and its safety.

To join the study, participants need to be aged between 45 and 85 years and have been diagnosed with MCI based on specific criteria. They should also have mild changes in their cognitive abilities as assessed by a doctor. Importantly, candidates must not be taking certain medications, like antidepressants or antipsychotics, during the trial. Those who qualify will receive the medication and be monitored, helping researchers understand its effects on memory and overall brain health. Participants will need to provide written consent to take part in this important research.

Gender

ALL

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.