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Ginkgo Biloba Prevention Trial in Older Individuals

This study has been completed.
Office of Dietary Supplements (ODS)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute on Aging (NIA)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
National Center for Complementary and Integrative Health (NCCIH) Identifier:
First received: February 2, 2001
Last updated: March 11, 2013
Last verified: March 2013
Results First Received: March 27, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Conditions: Dementia
Alzheimer's Disease
Interventions: Drug: Ginkgo biloba
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment occured between September 2000 through June 2002 primarily using mass mailings from targeted lists such as voter's registration and commercially available lists. Some sites chose to supplement this approach with newspaper, radio and television ads plus newsletter articles, posters and community presentations.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After mailing brochures to potential participants, we conducted a telephone screening followed by an in-person clinic visit to finalize eligibility. Randomization was done at a second visit within close proximity to the screening visit.

Reporting Groups
Ginkgo Biloba EGb 761 Ginkgo biloba 120 mg twice daily
Placebo Placebo twice daily

Participant Flow:   Overall Study
    Ginkgo Biloba   Placebo
STARTED   1545 [1]   1524 [1] 
COMPLETED   1448 [2]   1426 [2] 
NOT COMPLETED   97   98 
Withdrawal by Subject                97                98 
[1] Randomized
[2] Reached endpoint of dementia, death or completion

  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
Ginkgo Biloba 120 mg twice daily, total 240 mg
Placebo Placebo 1 pill twice daily
Total Total of all reporting groups

Baseline Measures
   Ginkgo Biloba   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 1545   1524   3069 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   0   0   0 
>=65 years   1545   1524   3069 
[Units: Years]
Mean (Standard Deviation)
 79.1  (3.3)   79.1  (3.3)   79.1  (3.3) 
[Units: Participants]
Female   702   716   1418 
Male   843   808   1651 
Region of Enrollment 
[Units: Participants]
United States   1545   1524   3069 

  Outcome Measures
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1.  Primary:   Number of Participants With Incident Dementia   [ Time Frame: Brief neuropsychological testing every 6 months, detailed testing annually, average 6.1 years follow up ]

2.  Secondary:   Number of Participants With the Indicated Cardiovascular Disease or Mortality   [ Time Frame: 6 months ]

3.  Secondary:   Progression of Cognitive Decline in Standardized Z-score Scale. Higher Z-scores Indicate Worse Performance.   [ Time Frame: 6 months/annually ]

  Serious Adverse Events

  Other Adverse Events
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Time Frame Adverse event data were collected every six months at testing visits, and at interim 3 month adherence phone calls.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   0%  

Reporting Groups
Ginkgo Biloba EGb 761 Ginkgo biloba 120 mg twice daily
Placebo Placebo twice daily

Other Adverse Events
    Ginkgo Biloba   Placebo
Total, Other (not including serious) Adverse Events     
# participants affected / at risk   1504/1545 (97.35%)   1469/1524 (96.39%) 
General disorders     
non-hospitalized self-reported symptom † 1     
# participants affected / at risk   0/1545 (0.00%)   0/1524 (0.00%) 
# events   0   0 
All adverse events † 1 [3]     
# participants affected / at risk   1504/1545 (97.35%)   1469/1524 (96.39%) 
# events   1504   1469 
Self-reported non-hospitalized symptom collected every 6 months † 1     
# participants affected / at risk   1504/1545 (97.35%)   1469/1524 (96.39%) 
# events   1504   1469 
Events were collected by systematic assessment
1 Term from vocabulary, COSTART
[3] There were no statistically significant differences.

  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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