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| 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
| 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. |
| 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. |
| Description | |
|---|---|
| Ginkgo Biloba | EGb 761 Ginkgo biloba 120 mg twice daily |
| Placebo | Placebo twice daily |
| 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
| Description | |
|---|---|
| Ginkgo Biloba | 120 mg twice daily, total 240 mg |
| Placebo | Placebo 1 pill twice daily |
| 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
| 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 ] |
More Information
| 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 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. |
| Responsible Party: | Steven T. DeKosky MD, University of Pittsburgh/University of Virginia |
| 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: | November 1, 2010 |
| Health Authority: | United States: Food and Drug Administration |
