Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Ginkgo Biloba Prevention Trial in Older Individuals

This study has been completed.
Sponsor:
Collaborators:
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)
ClinicalTrials.gov Identifier:
NCT00010803
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;   Endpoint Classification: Safety/Efficacy Study;   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
  Description
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.
No text entered.

Reporting Groups
  Description
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 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   0   0   0 
>=65 years   1545   1524   3069 
Age 
[Units: Years]
Mean (Standard Deviation)
 79.1  (3.3)   79.1  (3.3)   79.1  (3.3) 
Gender 
[Units: Participants]
     
Female   702   716   1418 
Male   843   808   1651 
Region of Enrollment 
[Units: Participants]
     
United States   1545   1524   3069 


  Outcome Measures
  Show All 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 ]
  Hide Outcome Measure 2

Measure Type Secondary
Measure Title Number of Participants With the Indicated Cardiovascular Disease or Mortality
Measure Description Myocardial infarction (MI), angina, stroke (CVA), transient ischemic attack (TIA), combined coronary heart disease (CHD) (MI/angina), combined cerebrovascular (CVA/TIA), peripheral vascular disease, and mortality
Time Frame 6 months  
Safety Issue No  

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.
Total cohort of 3069 based on same design as primary outcome, ITT.

Reporting Groups
  Description
Ginkgo Biloba 120 mg twice daily, total 240 mg
Placebo Placebo 1 pill twice a day

Measured Values
   Ginkgo Biloba   Placebo 
Participants Analyzed 
[Units: Participants]
 1545   1524 
Number of Participants With the Indicated Cardiovascular Disease or Mortality 
[Units: Participants]
   
Total Mortality   197   188 
Atherosclerotic CHD Mortality   45   42 
Incident MI   68   60 
Incident Angina   66   76 
Incident CHD (MI &/or angina)   107   110 
Incident CHF   112   122 
Incident Stroke   73   59 
Incident TIA   27   31 
Incident CVD (stroke &/or TIA)   99   88 
Total CHD and CVD   157   154 


Statistical Analysis 1 for Number of Participants With the Indicated Cardiovascular Disease or Mortality
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
Method [3] Log Rank
P Value [4] 0.70
Hazard Ratio (HR) [5] 1.04
95% Confidence Interval 0.85 to 1.27
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Total Mortality
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  Previously provided
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
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Statistical Analysis 2 for Number of Participants With the Indicated Cardiovascular Disease or Mortality
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
Method [3] Log Rank
P Value [4] 0.78
Hazard Ratio (HR) [5] 1.06
95% Confidence Interval 0.70 to 1.62
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Atherosclerotic CHD mortality
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  Previously provided
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
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Statistical Analysis 3 for Number of Participants With the Indicated Cardiovascular Disease or Mortality
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
Method [3] Log Rank
P Value [4] 0.54
Hazard Ratio (HR) [5] 1.12
95% Confidence Interval 0.79 to 1.58
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Incident Myocardial Infarction
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  Previously provided
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 4 for Number of Participants With the Indicated Cardiovascular Disease or Mortality
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
Method [3] Log Rank
P Value [4] 0.32
Hazard Ratio (HR) [5] 0.84
95% Confidence Interval 0.61 to 1.18
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Incident Angina
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  Previously Provided
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
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Statistical Analysis 5 for Number of Participants With the Indicated Cardiovascular Disease or Mortality
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
Method [3] Log Rank
P Value [4] 0.66
Hazard Ratio (HR) [5] 0.94
95% Confidence Interval 0.72 to 1.23
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Incident CHD
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  Previously provided
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 6 for Number of Participants With the Indicated Cardiovascular Disease or Mortality
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
Method [3] Log Rank
P Value [4] 0.48
Hazard Ratio (HR) [5] 0.91
95% Confidence Interval 0.71 to 1.18
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Incident CHF
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  Previously Provided
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 7 for Number of Participants With the Indicated Cardiovascular Disease or Mortality
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
Method [3] Log Rank
P Value [4] 0.25
Hazard Ratio (HR) [5] 0.87
95% Confidence Interval 0.52 to 1.45
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Incident Stroke
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  Previously provided
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 8 for Number of Participants With the Indicated Cardiovascular Disease or Mortality
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
Method [3] Log Rank
P Value [4] 0.59
Hazard Ratio (HR) [5] 0.87
95% Confidence Interval 0.52 to 1.45
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Incident TIA
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  Previously provided
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 9 for Number of Participants With the Indicated Cardiovascular Disease or Mortality
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
Method [3] Log Rank
P Value [4] 0.42
Cox Proportional Hazard [5] 1.12
95% Confidence Interval 0.84 to 1.50
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Incident CVD
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  Previously provided
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 10 for Number of Participants With the Indicated Cardiovascular Disease or Mortality
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
Method [3] Log Rank
P Value [4] 0.98
Hazard Ratio (HR) [5] 1.00
95% Confidence Interval 0.80 to 1.25
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Total CHD and CVD combined
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  Previously provided
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
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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
  Hide 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