Guanfacine Treatment for Prefrontal Cognitive Dysfunction in Elderly Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Mean in the Prefrontal Executive Function Z-score (PEF6_6)
研究概览
简要总结
This proposal aims to determine whether low does of the alpha-2A-adrenoceptor agonist guanfacine can improve deficits in prefrontally-mediated cognitive functions in healthy elderly subjects.
详细描述
Primary:
- To determine whether low does of the α2A-adrenoceptor agonist guanfacine can improve deficits in prefrontally-mediated working memory and executive control functions, in healthy elderly subjects. Subjects will be randomly assigned to receive placebo or guanfacine at one of two dose levels: 0.1 mg, or 0.5 mg daily at bedtime in double-blind fashion for twelve weeks.
Secondary:
- To determine whether guanfacine can favorably influence global status and quality of life (QOL) in healthy elderly subjects.
- To determine whether low-dose guanfacine is safe and well-tolerated in healthy elderly subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Subjects enrolled will be nondemented, male and female individuals who meet the following inclusion criteria:
- •75 years of age or older
- •Fluent in English
- •Stable medical condition for at least 4 weeks prior to Screening visit
- •Stable dose of non-excluded medications for at least 4 weeks prior to Screening visit
排除标准
- •Mild Cognitive Impairment (Amnestic MCI)
- •Clinically significant neurologic disease
- •Clinically significant or unstable medical conditions that would interfere with participation in the trial
- •Known hypersensitivity to guanfacine
- •History of alcohol or substance abuse or dependence within the past 5 years
- •Active major psychiatric disorders, including major depression
- •History of mental retardation
- •Significant abnormalities on clinical laboratories, ECG, or physical examination
- •Impairment of visual or auditory acuity sufficient to interfere with completion of study procedures
- •Education level < 6 years
研究组 & 干预措施
Guanfacine 0.1 mg po qhs
干预措施: Guanfacine (Drug)
Guanfacine 0.5 mg po qhs
干预措施: Guanfacine (Drug)
Placebo po qhs
干预措施: Placebo (Drug)
结局指标
主要结局
Mean in the Prefrontal Executive Function Z-score (PEF6_6)
时间窗: 12 weeks
The primary outcome measure (PEF6_Z) is the mean of z-scores for 6 executive function tasks (CANTAB: Spatial Working Memory, Stockings of Cambridge, Intradimensiona/Extradimensional Shift, Paired Associates Learning; Stroop Color Word Score, Trail Making Test - B). The score is composed of six component scales coded as z scores that measures cognitive functioning in which higher scores represent better cognitive functioning; therefore, the least squares means listed here represent mean outcome changes from baseline
次要结局
- Quality of Life (SF-36 MCS)(12 weeks)
- Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC)(12 weeks)