Ginkgo Biloba Prevention Trial in Older Individuals

This study has been completed.
Sponsor:
Collaborators:
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
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


  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 ]

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
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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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