Trial · NCT00010803
Ginkgo Biloba Prevention Trial in Older Individuals
NCT00010803, Phase 3, Completed, National Center for Complementary and Integrative Health (NCCIH); results first posted 2010-09-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ginkgo Biloba Prevention Trial in Older Individuals. Trials, record NCT00010803. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00010803
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ginkgo Biloba Prevention Trial in Older Individuals
- NCT number
- NCT00010803
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 3,069 participants, actual
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Conditions
- Dementia, Alzheimer's Disease
- Interventions
- Ginkgo biloba, Placebo
- First posted
- 2001-02-05
- Last updated
- 2013-03-14
- Results first posted
- 2010-09-16
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Incident Dementia | Brief neuropsychological testing every 6 months, detailed testing annually, average 6.1 years follow up | All cause dementia based on DSM-IV criteria as determined by an expert panel of clinicians using an adjudication process. A full neuropsychological battery was administered annually, or at 6 month visit if there was a diagnosis of dementia or initiation of medication for dementia by private physician, or change in Modified Mini Mental State Exam (3MSE), Clinical Dementia Rating (CDR), or Alzheimer Disease Assessment Scale (ADAS-Cog). Decline on tests scores based on an algorithm resulted in a neurological exam and brain imaging. These data were used in the adjudication process. |
| Secondary | Number of Participants With the Indicated Cardiovascular Disease or Mortality | 6 months | 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 |
| Secondary | Progression of Cognitive Decline in Standardized Z-score Scale. Higher Z-scores Indicate Worse Performance. | 6 months/annually | Rate of annual change by cognitive domain in standardized Z-score scale. Higher Z-scores indicate worse performance. Best score = -2.0 Z-score change per year (improvement); worse score = 2.0 Z-score change per year (decline). |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Incident Dementia | Brief neuropsychological testing every 6 months, detailed testing annually, average 6.1 years follow up | Subjects developing incident dementia during trial in each group, intention to treat (ITT). | Participants | NUMBER |
| SECONDARY | Number of Participants With the Indicated Cardiovascular Disease or Mortality | 6 months | Total cohort of 3069 based on same design as primary outcome, ITT. | Participants | NUMBER |
| SECONDARY | Progression of Cognitive Decline in Standardized Z-score Scale. Higher Z-scores Indicate Worse Performance. | 6 months/annually | Final test scores were imputed for participants who did not have a cognitive exam during the year before death (n=234) or dropout (n=154) or during the month before censoring for dementia (n=70). Factors in imputed model included treatment group, demographic and health history variables, study site, and other cognitive scores. Higher Z-scores worse | Z-score units | MEAN |
Source ClinicalTrials.gov
Results by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Incident Dementia | Ginkgo Biloba | 277 | Participants | ||
| Number of Participants With Incident Dementia | Placebo | 246 | Participants | ||
| Number of Participants With the Indicated Cardiovascular Disease or Mortality | Ginkgo Biloba | Total Mortality | 197 | Participants | |
| Number of Participants With the Indicated Cardiovascular Disease or Mortality | Placebo | Total Mortality | 188 | Participants | |
| Number of Participants With the Indicated Cardiovascular Disease or Mortality | Ginkgo Biloba | Atherosclerotic CHD Mortality | 45 | Participants | |
| Number of Participants With the Indicated Cardiovascular Disease or Mortality | Placebo | Atherosclerotic CHD Mortality | 42 | Participants | |
| Number of Participants With the Indicated Cardiovascular Disease or Mortality | Ginkgo Biloba | Incident MI | 68 | Participants | |
| Number of Participants With the Indicated Cardiovascular Disease or Mortality | Placebo | Incident MI | 60 | Participants | |
| Number of Participants With the Indicated Cardiovascular Disease or Mortality | Ginkgo Biloba | Incident Angina | 66 | Participants | |
| Number of Participants With the Indicated Cardiovascular Disease or Mortality | Placebo | Incident Angina | 76 | Participants |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ginkgo Biloba | 1,545 | |
| Overall Study | STARTED | Placebo | 1,524 | |
| Overall Study | COMPLETED | Ginkgo Biloba | 1,448 | |
| Overall Study | COMPLETED | Placebo | 1,426 | |
| Overall Study | NOT COMPLETED | Ginkgo Biloba | 97 | |
| Overall Study | NOT COMPLETED | Placebo | 98 |
Source ClinicalTrials.gov
Adverse events16
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | non-hospitalized self-reported symptom | General disorders | Ginkgo Biloba | 0 | 1,545 | 0 |
| other | non-hospitalized self-reported symptom | General disorders | Placebo | 0 | 1,524 | 0 |
| other | All adverse events | General disorders | Ginkgo Biloba | 1,504 | 1,545 | 1,504 |
| other | All adverse events | General disorders | Placebo | 1,469 | 1,524 | 1,469 |
| other | Self-reported non-hospitalized symptom collected every 6 months | General disorders | Ginkgo Biloba | 1,504 | 1,545 | 1,504 |
| other | Self-reported non-hospitalized symptom collected every 6 months | General disorders | Placebo | 1,469 | 1,524 | 1,469 |
| serious | Death | General disorders | Ginkgo Biloba | 197 | 1,545 | 197 |
| serious | Death | General disorders | Placebo | 188 | 1,524 | 188 |
| serious | Bleeding | General disorders | Ginkgo Biloba | 138 | 1,545 | 171 |
| serious | Bleeding | General disorders | Placebo | 140 | 1,524 | 178 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ginkgo Biloba | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Ginkgo Biloba | 1,504 | 1,545 |
| Total, other adverse events | Placebo | 1,469 | 1,524 |
| Total, serious adverse events | Ginkgo Biloba | 1,000 | 1,545 |
| Total, serious adverse events | Placebo | 961 | 1,524 |
Source ClinicalTrials.gov
Papers12
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01AT000162 | Ginkgo Biloba Prevention Trial in Older Individuals | LOPEZ, OSCAR L. | UNIVERSITY OF PITTSBURGH AT PITTSBURGH | NATIONAL CENTER FOR COMPLEMENTARY & INTEGRATIVE HEALTH | 1999 to 2009 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ginkgo Biloba vs Placebo: Number of Participants With Incident Dementia | Trial comparisons |
| Ginkgo Biloba vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00010803
GET https://conductscience.org/api/trials/v1/NCT00010803/results?page=2