Mild Cognitive Impairment — EGb 761 in the Syndrome of MCI With Concomitant CVD
Citation(s)
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.
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.
Evaluating the Role of EGb 761 in the Syndrome of Mild Cognitive Impairment With Concomitant Cerebrovascular Disease (MCI + CVD)
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
