drugset / Trial / NCT04525144
EGb 761 in the Syndrome of MCI With Concomitant CVD
Phase 2
Recruiting
134 enrolled
National Neuroscience Institute
Dr. Willmar Schwabe GmbH & Co. KG · collab
RandomizedParallel-groupSingle-blindTreatment
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 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.
Timeline
- Start
- 2020-10-26
- Primary completion
- 2025-12
- Completion
- 2026-11
Publications
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ginkgo Biloba Extract | Traditional medicine (herbal / TCM) | 120 mg | — |