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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
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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
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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.

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

Serious Adverse Events
    Ginkgo Biloba   Placebo
Total, serious adverse events     
# participants affected / at risk   1000/1545 (64.72%)   961/1524 (63.06%) 
General disorders     
Death † 1     
# participants affected / at risk   197/1545 (12.75%)   188/1524 (12.34%) 
# events   197   188 
Bleeding † 1 [3]     
# participants affected / at risk   138/1545 (8.93%)   140/1524 (9.19%) 
# events   171   178 
All other SAEs † 1     
# participants affected / at risk   374/1545 (24.21%)   358/1524 (23.49%) 
# events   1627   1647 
Vascular disorders     
Coronary Heart Disease Total † 1 [4]     
# participants affected / at risk   211/1545 (13.66%)   204/1524 (13.39%) 
# events   285   259 
Stroke † 1 [5]     
# participants affected / at risk   80/1545 (5.18%)   71/1524 (4.66%) 
# events   88   82 
Events were collected by systematic assessment
1 Term from vocabulary, COSTART
[3] Gastrointestinal and all other
[4] Myocardial infarction, angina, angioplasty, coronary artery bypass graft, coronary heart disease death
[5] Ischemic, hemorrhagic and unknown




  Other Adverse Events


  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
No text entered.


  More Information