Status:

RECRUITING

EGb 761 in the Syndrome of MCI With Concomitant CVD

Lead Sponsor:

National Neuroscience Institute

Collaborating Sponsors:

Dr. Willmar Schwabe GmbH & Co. KG

Conditions:

Mild Cognitive Impairment

Cerebrovascular Disease

Eligibility:

All Genders

45-85 years

Phase:

PHASE2

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 random...

Detailed Description

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 240 mg in rando...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

October 26 2020

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

November 1 2026

Estimated Enrollment :

134 Patients enrolled

Trial Details

Trial ID

NCT04525144

Start Date

October 26 2020

End Date

November 1 2026

Last Update

November 17 2022

Active Locations (1)

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National Neuroscience Institute

Singapore, Singapore, 308433