Mild Cognitive ImpairmentPhase 2NCT04525144
EGb 761 in the Syndrome of MCI With Concomitant CVD
A Phase 2 study testing Tebonin Forte in people with Mild Cognitive Impairment and Cerebrovascular Disease, run by National Neuroscience Institute at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment, Cerebrovascular Disease
- What is being tested?
- Tebonin Forte
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteSingapore
- Study dates
- 26 Oct 2020to Nov 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
National Neuroscience Institute
Singapore, 308433
Joanna Wang, (65) 63577546, ctru@nni.com.sg
Nagaendran Kandiah, MRCP;FAMS
About this study
Official title: Evaluating the Role of EGb 761 in the Syndrome of Mild Cognitive Impairment With Concomitant Cerebrovascular Disease (MCI + CVD)
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.
Read the 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.
- Conditions
- Mild Cognitive Impairment, Cerebrovascular Disease
- Being tested
- Tebonin Forte
- Medical subject headings
- Cognitive Dysfunction, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tebonin ForteDrug
Dietary supplement: Gingko biloba EGb 761
| Study group | Role | What they receive |
|---|---|---|
| Tebonin Forte | Experimental | Treatment: 120mg, twice a day, 52 weeks Receives: Drug: Tebonin Forte |
| Control | No intervention | No Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alzheimer's Disease Assessment Scale-Cognitive 13 (ADAS-Cog 13)
Cognitive assessment
Measured: 52 weeks
Clinical Dementia Rating Sum of Boxes Scores (CDR-SOB)
Functional assessment
Measured: 52 weeks
Secondary outcomes (2)
Visual Cognitive Assessment Tool (VCAT)
Cognitive assessment
Measured: 52 weeks
Mild Behavioural Impairment Checklist (MBI-C)
Behavioral assessment
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2020
- Study start26 Oct 2020
- Primary completionDec 2025 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Neuroscience Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Willmar Schwabe GmbH & Co. KG
- Responsible party
- Sponsor
- Investigators
- Kok Pin Ng, Principal investigator, National Neuroscience Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04525144
- Sponsor's protocol ID
- EGB-MCI
- Status last verified
- Nov 2022
- First submitted
- 20 Aug 2020
- Last updated
- 17 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 22459264Muller 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.
PubMed 28460580Gavrilova 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.
PubMed 24633934Ihl 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.
PubMed 21140383Yuan 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.
PubMed 27940086