NCT04525144 · Phase 2 · RECRUITING
EGb 761 in the Syndrome of MCI With Concomitant CVD
This trial tests EGb 761, a standardized Ginkgo biloba extract sold as Tebonin Forte, in people with mild cognitive impairment (MCI) and signs of small blood vessel damage in the brain. It looks at thinking and overall clinical outcomes, plus safety. It is a Phase 2 trial, testing whether it works and is safe, not yet proven or approved for this use.
You may qualify if
- 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
You're excluded if
- 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.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2022-11-17