Text Size

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 Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00010803
First received: February 2, 2001
Last updated: March 11, 2013
Last verified: March 2013
History of Changes
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
  Hide Participant Flow

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
  Hide Baseline Characteristics

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  
Number of Participants  
[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 ]
  Show Outcome Measure 1

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

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


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


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
No text entered.  


Results Point of Contact:  
Name/Title: Steven T. DeKosky MD
Organization: University of Virginia
phone: 434-924-5118
e-mail: SD3ZC@hscmail.mcc.virginia.edu


Publications of Results:

Other Publications:

Publications automatically indexed to this study:


Responsible Party: National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier: NCT00010803     History of Changes
Obsolete Identifiers: NCT00004535
Other Study ID Numbers: U01 AT000162-01M
Study First Received: February 2, 2001
Results First Received: March 27, 2009
Last Updated: March 11, 2013
Health Authority: United States: Food and Drug Administration