- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04525144
EGb 761 in the Syndrome of MCI With Concomitant CVD
Evaluating the Role of EGb 761 in the Syndrome of Mild Cognitive Impairment With Concomitant Cerebrovascular Disease (MCI + CVD)
Study Overview
Status
Conditions
Intervention / Treatment
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 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. 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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Joanna Wang
- Phone Number: (65) 6357 7635
- Email: joanna.wang.s@singhealth.com.sg
Study Locations
-
-
-
Singapore, Singapore, 308433
- Recruiting
- National Neuroscience Institute
-
Contact:
- Joanna Wang
- Phone Number: (65) 63577546
- Email: ctru@nni.com.sg
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Principal Investigator:
- Nagaendran Kandiah, MRCP;FAMS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tebonin Forte
Treatment: 120mg, twice a day, 52 weeks
|
Dietary supplement: Gingko biloba EGb 761
|
No Intervention: Control
No Treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alzheimer's Disease Assessment Scale-Cognitive 13 (ADAS-Cog 13)
Time Frame: 52 weeks
|
Cognitive assessment
|
52 weeks
|
Clinical Dementia Rating Sum of Boxes Scores (CDR-SOB)
Time Frame: 52 weeks
|
Functional assessment
|
52 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Cognitive Assessment Tool (VCAT)
Time Frame: 52 weeks
|
Cognitive assessment
|
52 weeks
|
Mild Behavioural Impairment Checklist (MBI-C)
Time Frame: 52 weeks
|
Behavioral assessment
|
52 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kok Pin Ng, National Neuroscience Institute
Publications and helpful links
General Publications
- Herrschaft H, Nacu A, Likhachev S, Sholomov I, Hoerr R, Schlaefke S. Ginkgo biloba extract EGb 761(R) in dementia with neuropsychiatric features: a randomised, placebo-controlled trial to confirm the efficacy and safety of a daily dose of 240 mg. J Psychiatr Res. 2012 Jun;46(6):716-23. doi: 10.1016/j.jpsychires.2012.03.003. Epub 2012 Mar 27.
- Muller WE, Eckert A, Eckert GP, Fink H, Friedland K, Gauthier S, Hoerr R, Ihl R, Kasper S, Moller HJ. Therapeutic efficacy of the Ginkgo special extract EGb761(R) within the framework of the mitochondrial cascade hypothesis of Alzheimer's disease. World J Biol Psychiatry. 2019 Mar;20(3):173-189. doi: 10.1080/15622975.2017.1308552. Epub 2017 May 2.
- Gavrilova SI, Preuss UW, Wong JW, Hoerr R, Kaschel R, Bachinskaya N; GIMCIPlus Study Group. Efficacy and safety of Ginkgo biloba extract EGb 761 in mild cognitive impairment with neuropsychiatric symptoms: a randomized, placebo-controlled, double-blind, multi-center trial. Int J Geriatr Psychiatry. 2014 Oct;29(10):1087-95. doi: 10.1002/gps.4103. Epub 2014 Mar 16.
- Ihl R, Bachinskaya N, Korczyn AD, Vakhapova V, Tribanek M, Hoerr R, Napryeyenko O; GOTADAY Study Group. Efficacy and safety of a once-daily formulation of Ginkgo biloba extract EGb 761 in dementia with neuropsychiatric features: a randomized controlled trial. Int J Geriatr Psychiatry. 2011 Nov;26(11):1186-94. doi: 10.1002/gps.2662. Epub 2010 Dec 7.
- Yuan Q, Wang CW, Shi J, Lin ZX. Effects of Ginkgo biloba on dementia: An overview of systematic reviews. J Ethnopharmacol. 2017 Jan 4;195:1-9. doi: 10.1016/j.jep.2016.12.005. Epub 2016 Dec 7.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EGB-MCI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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