EGb 761 in the Syndrome of MCI With Concomitant CVD
Study Details
Study Description
Brief Summary
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.
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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Tebonin Forte 120mg, twice a day, 52 weeks |
Drug: Tebonin Forte
Dietary supplement: Gingko biloba EGb 761
|
| No Intervention: Control
|
Outcome Measures
Primary Outcome Measures
- Alzheimer's Disease Assessment Scale-Cognitive 13 (ADAS-Cog 13) [52 weeks]
- Clinical Dementia Rating Sum of Boxes Scores (CDR-SOB) [52 weeks]
Secondary Outcome Measures
- Visual Cognitive Assessment Tool (VCAT) [52 weeks]
- Mild Behavioural Impairment Checklist (MBI-C) [52 weeks]
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Neuroscience Institute | Singapore | Singapore | 308433 |
Sponsors and Collaborators
- National Neuroscience Institute
- Dr. Willmar Schwabe GmbH & Co. KG
Investigators
- Principal Investigator: Nagaendran Kandiah, National Neuroscience Institute
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- Herrschaft H, Nacu A, Likhachev S, Sholomov I, Hoerr R, Schlaefke S. Ginkgo biloba extract EGb 761® 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.
- 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.
- Müller WE, Eckert A, Eckert GP, Fink H, Friedland K, Gauthier S, Hoerr R, Ihl R, Kasper S, Möller HJ. Therapeutic efficacy of the Ginkgo special extract EGb761(®) 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. Review.
- 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. Review.
- EGB-MCI