Phase 3 Completed N=3,069 Randomized Double-blind Prevention

Ginkgo Biloba Prevention Trial in Older Individuals

Dementia · Alzheimer's Disease

Source: ClinicalTrials.gov NCT00010803 ↗

Enrolled (actual)

3,069

Serious AEs

63.9%

Results posted

Sep 2010

Primary outcomePrimary: Number of Participants With Incident Dementia — 277; 246 Participants — p=0.21

Summary

This study will determine the effect of 240mg/day Ginkgo biloba in decreasing the incidence of dementia and specifically Alzheimer's disease (AD), slowing cognitive decline and functional disability, reducing incidence of cardiovascular disease, and decreasing total mortality.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Incident Dementia	277; 246	0.21
SECONDARY Number of Participants With the Indicated Cardiovascular Disease or Mortality	197; 188; 45; 42; 68; 60	0.70
SECONDARY Progression of Cognitive Decline in Standardized Z-score Scale. Higher Z-scores Indicate Worse Performance.	0.069; 0.071; 0.043; 0.041; 0.043; 0.048	.65

Eligibility Criteria

Inclusion Criteria

Non-demented participants
Willing to participate in a seven-year follow-up trial of Ginkgo Biloba
English is their usual language
Willing informant who has frequent contact with the participant

Exclusion Criteria

Currently on anticoagulant therapy
Cancer diagnosed and treated within the past two years (except for skin cancer)
Participant with class III - IV congestive heart failure
Currently being treated with psychopharmacological drugs for depression
Hospitalized for depression within the last year
Taking Aricept (or similar agents) for cognitive problems or dementia
Baseline blood creatinine >2
Baseline SGGT is a marker of liver function (3 x normal>or=90 IU)
Baseline hematocrit or=15,000

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00010803). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.