Successful Aging and Enrichment (SAGE): Effects of Environmental Stimulation on Cognitive Health and Neuroplasticity
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Trail Making Test A
研究概览
简要总结
Progress has been made in understanding the impact of different kinds of structured intervention programs in improving cognitive processing and performance in older adults, and in determining whether there is electrophysiological evidence for neuroplasticity in individuals over the age of 65.
详细描述
Study Procedures
Pre-Intervention Assessment The initial screening evaluation will take place over two half-day sessions, each lasting 3 to 3.5 hours in a designated room in the Laboratory of Healthy Cognitive Aging, Center for Brain/Mind Medicine, Brigham and Women's Hospital (BWH), 221 Longwood Avenue, Boston, Massachusetts (MA).
The sessions can be completed over one or two days, depending on the subject's preference.
Pre-Intervention Assessment Session 1 The first session will include completion of informed consent, a medical history, demographic information, including socioeconomic status (SES), survey questionnaires, and tests of visual acuity.
Screening Evaluation (for inclusion/exclusion)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be 65 or older
- •Have ≥ 8 years of education
- •Be sufficiently fluent in the English language to understand instructions and perform the neuropsychological tests (as the purpose of the project is to study healthy aging)
- •Score above levels indicating possible cognitive impairment on the Mini Mental State Exam (MMSE) (≥ 26)
- •Have an estimated intelligence quotient (IQ) score ≥ 90 based on the American National Reading Test (AmNART)
- •Have a score within 2 standard deviations (SD) of the age-appropriate mean on the short form of the Boston Naming Test
- •Have a score within 2 SD of the age-appropriate mean on the Logical Memory Subtest of the Wechsler Memory Scale-Third Edition
排除标准
- •History of Central Nervous System (CNS) diseases or major psychiatric disorders based on Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria
- •Score of greater than 10 on the Geriatric Depression Scale
- •Corrected visual acuity worse than 20-50 as tested by a Snellen wall chart
- •Severe hearing disability that would interfere with their ability to participate in the experiments (e.g., to hear instructions and participate in cognitive testing)
- •Medical conditions (e.g., heart or pulmonary disease) that would prevent them from participating in the physical exercise training program
- •Evidence of substantial functional decline based on interview questions and completion of a questionnaire based on the Clinical Dementia Rating Scale by an informant who knows the subject well
结局指标
主要结局
Trail Making Test A
时间窗: End of Study - 5 weeks post-baseline
Tests of visual attention and task switching Timed task - Max time allotted: 150 seconds
Trail Making Test B
时间窗: End of Study - 5 weeks post-baseline
Tests of visual attention and task switching Timed - Max time allotted: 300 seconds
Digit Symbol Coding, Weschler Adult Intelligence Scale (WAIS-IV)
时间窗: End of Study - 5 weeks post-baseline
A test of processing speed 90 seconds allowed - Higher scores indicate faster processing speed Maximum Score: 91 Minimum Score: 0
Cambridge Neuropsychological Test Automated Battery (CANTAB), a computerized assessment of cognitive functions
时间窗: End of Study - 5 weeks post-baseline
* CANTAB Paired Associate Learning (PAL) - assesses visual memory and new learning * CANTAB Attention Switching Task (AST) - measures cued attentional set-shifting * CANTAB Reaction Time (RTI) - measures speed of response to visual target when the stimulus is either predictable (simple RT) or unpredictable (choice RT) * CANTAB Spatial Span (SSP) - assesses working memory * CANTAB One Touch Stockings of Cambridge (OTS) - a test of non-verbal reasoning
Controlled Oral Word Association Test (COWAT)
时间窗: End of Study - 5 weeks post-baseline
A test of verbal retrieval and word generation Total score is measured by calculating the total number of acceptable words produced for all three letters
Categorical Fluency
时间窗: End of study - 5 weeks post-baseline
A test of rapid retrieval of semantic knowledge Scored by counting the number of correct unique semantic category items produced
次要结局
未报告次要终点
研究者
Kirk Daffner, MD
Chief, Division of Cognitive and Behavioral Neurology
Brigham and Women's Hospital