Multicenter, Open-Label, Prospective Study Shows Safety and Therapeutic Benefits of a Defined Ginkgo Biloba Extract for Adults with Major Neurocognitive Disorder.
- 2024-07-26
- Dementia and geriatric cognitive disorders 53(6)
- Debashish Chowdhury
- Ajit Kumar Roy
- V Radhika Reddy
- Yogesh Kumar Gupta
- Pushkar Nigam
- Robert Hoerr
- PubMed: 39068924
- DOI: 10.1159/000540385
Study Design
- Type
- Clinical Trial
- Sample size
- n = 150
- Population
- 150 patients aged ≥50 years with major neurocognitive disorder
- Methods
- Open-label, multicenter, single-arm, phase IV trial; 120 mg EGb 761® twice daily for 18 weeks
- Blinding
- Open-label
- Duration
- 18 weeks
- Funding
- Unclear
- Large Human Trial
Introduction
The safety and therapeutic effects of Gingko biloba extract EGb 761® to treat cognitive decline have been demonstrated in numerous clinical trials. However, trials in Indian populations have been lacking.Methods
This open-label, multicenter, single-arm, phase IV trial enrolled 150 patients aged ≥50 years with major neurocognitive disorder due to Alzheimer's disease, major vascular neurocognitive disorder, or mixed forms of both according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria and a Mini-Mental State Examination (MMSE) score of 12-24. Patients took 120 mg EGb 761® twice daily for 18 weeks. Therapeutic effects were assessed by CERAD constructional praxis and recall of constructional praxis (CERAD CP, CERAD recall of CP), Trail-Making Test (TMT), Behavioral Pathology in Alzheimer's Disease (BEHAVE-AD), Clinical Global Impressions (CGI) scale, and 11-point box scales for tinnitus and vertigo. Safety assessment was based on the occurrence of adverse events as well as changes in clinical, laboratory, and functional parameters.Results
After 18 weeks, significant improvements compared to baseline were found in constructional praxis (CERAD CP, p < 0.0001), memory (CERAD recall of CP, p < 0.0001), speed and executive functioning (TMT A, p < 0.0001; TMT B, p < 0.0001), and behavioral symptoms (BEHAVE-AD, p < 0.0001). Forty-five adverse events were reported in 33 (22.0%) patients in total, including ten presumed adverse drug reactions in 9 (6.0%) patients. Headache and diarrhea of mild-to-moderate severity were the most frequent events. Two serious adverse events, both considered unrelated to the study drug, occurred in 2 (1.3%) patients.Conclusion
This study confirmed the favorable safety profile and suggested therapeutic benefits of EGb 761® in Indian patients with major neurocognitive disorder.Research Insights
significant improvements compared to baseline were found in constructional praxis (CERAD CP, p < 0.0001)
- Effect
- Beneficial
- Effect size
- Small
- Dose
- 120 mg twice daily
significant improvements compared to baseline were found in ... executive functioning (TMT B, p < 0.0001)
- Effect
- Beneficial
- Effect size
- Small
- Dose
- 120 mg twice daily
significant improvements compared to baseline were found in ... memory (CERAD recall of CP, p < 0.0001)
- Effect
- Beneficial
- Effect size
- Small
- Dose
- 120 mg twice daily
significant improvements compared to baseline were found in ... speed (TMT A, p < 0.0001)
- Effect
- Beneficial
- Effect size
- Small
- Dose
- 120 mg twice daily
significant improvements compared to baseline were found in ... behavioral symptoms (BEHAVE-AD, p < 0.0001)
- Effect
- Beneficial
- Effect size
- Small
- Dose
- 120 mg twice daily
Adverse Events Reported
This study confirmed the favorable safety profile
- Finding
- Reported
Headache and diarrhea of mild-to-moderate severity were the most frequent events.
- Finding
- Reported
- Magnitude
- most frequent events
Headache and diarrhea of mild-to-moderate severity were the most frequent events.
- Finding
- Reported
- Magnitude
- most frequent events
Two serious adverse events, both considered unrelated to the study drug, occurred in 2 (1.3%) patients.
- Finding
- Reported
- Severity
- Serious adverse event
- Magnitude
- 2 events in 2 (1.3%) patients