EGb 761 in the Syndrome of MCI With Concomitant CVD

National Neuroscience Institute

Status and phase

Enrolling

Phase 2

Conditions

Mild Cognitive Impairment

Cerebrovascular Disease

Treatments

Drug: Tebonin Forte

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04525144

EGB-MCI

Details and patient eligibility

About

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.

Full description

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.

Enrollment

134 estimated patients

Sex

All

Ages

45 to 85 years old

Volunteers

No Healthy Volunteers

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.