EGb 761 in the Syndrome of MCI With Concomitant CVD

NCT04525144 | Recruiting Phase 2

• 1 other identifier: EGB-MCI
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mild Cognitive Impairment; Cerebrovascular Disease

Outcome Measures

Primary Outcomes (2)

• Alzheimer's Disease Assessment Scale-Cognitive 13 (ADAS-Cog 13)

  Cognitive assessment

  52 weeks

• Clinical Dementia Rating Sum of Boxes Scores (CDR-SOB)

  Functional assessment

  52 weeks

Secondary Outcomes (2)

• Visual Cognitive Assessment Tool (VCAT)

  52 weeks

• Mild Behavioural Impairment Checklist (MBI-C)

  52 weeks

Study Arms (2)

Tebonin Forte

EXPERIMENTAL

Treatment: 120mg, twice a day, 52 weeks

Drug: Tebonin Forte

Control

NO INTERVENTION

No Treatment

Interventions

Tebonin Forte DRUG

Dietary supplement: Gingko biloba EGb 761

Tebonin Forte

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Neuroscience Institute: lead
• Dr. Willmar Schwabe GmbH & Co. KG: collaborator

Study Sites (1)

National Neuroscience Institute

Singapore, 308433, Singapore

RECRUITING

Related Publications (5)

• 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.

  PMID: 22459264 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.

  PMID: 28460580 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.

  PMID: 24633934 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.

  PMID: 21140383 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.

  PMID: 27940086 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction; Cerebrovascular Disorders

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Kok Pin Ng

  National Neuroscience Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joanna Wang

CONTACT

(65) 6357 7635; joanna.wang.s@singhealth.com.sg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2020
• First Posted: August 25, 2020
• Study Start: October 26, 2020
• Primary Completion: December 1, 2025
• Study Completion (Estimated): November 1, 2026
• Last Updated: November 17, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)