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Ginkgo Biloba Prevention Trial in Older Individuals

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ClinicalTrials.gov Identifier: NCT00010803
Recruitment Status : Completed
First Posted : February 5, 2001
Results First Posted : September 16, 2010
Last Update Posted : March 14, 2013
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)

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions: Dementia
Alzheimer's Disease
Interventions: Drug: Ginkgo biloba
Drug: Placebo

  Participant Flow

  Baseline Characteristics

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

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

  Limitations and Caveats

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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  More Information