Ginkgo Biloba Prevention Trial in Older Individuals
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 3,069
- 试验地点
- 5
- 主要终点
- Number of Participants With Incident Dementia
研究概览
简要总结
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.
详细描述
Participants will be studied in a randomized trial of 240 mg of Ginkgo biloba as compared to placebo in healthy men and women, at least 75 years old. The trial will last approximately 8 years. The intervention will be considered unsuccessful in those participants who succumb to dementia, including Alzheimer's Disease and vascular dementia. There are four clinical centers: Pittsburgh, PA; Hagerstown, MD; Winston-Salem, NC; and Sacramento, CA; and a Coordinating Center at the University of Washington, Seattle. There will be a clinic visit every 6 months to determine morbidity, mortality and change in cognition that will include repeat of ADAS, CDR, and 10 battery neuropsychological evaluation and informant interview. The primary endpoint is dementia, specifically Alzheimer's disease, secondary endpoint will include the incidence of vascular disease, changes in cognitive function scores over time, total mortality and changes in functional status. The diagnosis of dementia will be based on neuropsychological testing, neurological exam, MRI, functional measurements, and review by a central adjudication committee and classified by DSM IV, NINCDS criteria and ADRTC criteria for vascular disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 75 Years 至 —(Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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<30
- •Baseline white blood count>or=15,000
研究组 & 干预措施
Placebo
Placebo 1 pill twice a day
干预措施: Placebo (Drug)
Ginkgo biloba
Ginkgo biloba EGb761 120 mg twice daily
干预措施: Ginkgo biloba (Drug)
结局指标
主要结局
Number of Participants With Incident Dementia
时间窗: 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.
次要结局
- Number of Participants With the Indicated Cardiovascular Disease or Mortality(6 months)
- Progression of Cognitive Decline in Standardized Z-score Scale. Higher Z-scores Indicate Worse Performance.(6 months/annually)
