Health TrialsbyHealthPanel

EGb 761 in the Syndrome of MCI With Concomitant CVD

ConditionsMild Cognitive ImpairmentCerebrovascular Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age45-85
SponsorNational Neuroscience Institute

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tebonin Forte

    Drug

    Dietary supplement: Gingko biloba EGb 761

Treatment groups

134 Participants
are divided into 2 treatment groups
Group A: Tebonin ForteExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Alzheimer's Disease Assessment Scale-Cognitive 13 (ADAS-Cog 13)

Cognitive assessment

Time frame
52 weeks
2

Clinical Dementia Rating Sum of Boxes Scores (CDR-SOB)

Functional assessment

Time frame
52 weeks

Secondary outcomes

1

Visual Cognitive Assessment Tool (VCAT)

Cognitive assessment

Time frame
52 weeks
2

Mild Behavioural Impairment Checklist (MBI-C)

Behavioral assessment

Time frame
52 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Neuroscience Institute

Lead sponsor

Dr. Willmar Schwabe GmbH & Co. KG

Collaborator

Source ClinicalTrials.gov
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