Lifestyle Enriching Activities for Research in Neuroscience Intervention Trial: LEARNit Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Functional Magnetic Resonance Imaging (fMRI) Brain Scan as a Measure of Brain Function
研究概览
简要总结
The purpose of this study is to examine the effects of modifiable lifestyle factors including exercise and healthy living on brain health. The investigators will compare 2 types of interventions, moderate aerobic walking vs. healthy living education, over 6 months to evaluate changes in brain health, cognition, and physical function in older adults with cognitive concerns.
详细描述
Cognitive decline in older adults is a major public health issue. The cost of caring for older adults with substantial cognitive impairment, like those with Alzheimer's Disease in the US is approximately $200 billion a year, causing major societal, economic, and caregiving burden. Despite great advances towards diagnosing these problems, the discovery of effective treatments has been minimal. Exploring non-pharmacological interventions, such as exercise and healthy living, have gained momentum. These promising, modifiable lifestyle interventions have the potential for delaying disease onset and slowing decline in cognition. However, the therapeutic effect of lifestyle interventions in patients with mild cognitive impairment, a prime intervention period for treatment, is not well understood. Therefore, in this study, the investigators will examine brain, body, and cognitive changes in older adults who engage in moderate-aerobic walking or healthy living education.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female
- •English-speaking
- •55-80 years old
- •Exhibits sedentary behavior
- •Objective cognitive impairment
- •Mini-Mental State Exam score > 26
- •Perform at least 1 standard deviations below normative values on cognitive tests
- •Absence of dementia
- •Ability to complete both MRI and PET scans
- •Physically capable of completing health programs
排除标准
- •Baseline dementia
- •History of a neurological disorder
- •Current psychiatric illness
- •Head trauma with a loss of consciousness > 10 minutes
- •Severe sensory deficits
- •Substance abuse
- •Depression (GDS < 8 of 15)
- •Inability to perform intervention (e.g., inability to walk without assistance)
- •Contraindications to MRI scan (e.g., pacemaker)
结局指标
主要结局
Functional Magnetic Resonance Imaging (fMRI) Brain Scan as a Measure of Brain Function
时间窗: Baseline and Follow-up at 6 months
Functional MRI has proven to be an effective non-invasive, in-vivo tool for measuring brain function via the BOLD signal. Growing evidence supports that fMRI BOLD can detect neuronal changes that occur very early in the disease process. The hippocampus has been shown to be a selectively vulnerable region in AD, and several studies, including our own, identified a aberrant brain signal in the hippocampus in older adults. The typical range for this outcome is -10 to 10 with higher scores indicating better brain function.
Mnemonic Similarity Test as a Measure of Memory (Cognition)
时间窗: Baseline and Follow-up at 6 months
The participants will encode a series of objects presented on a computer. Following the encoding period, they will begin their fMRI scan and be asked to indicate if they recognize the objects on the screen, which include targets (previously seen objects), lures (objects that are similar to previously seen objects) and novel (unrelated objects). The discrimination between Targets and Lures will indicate the rate at which participants "correctly reject" the Lures (via pattern separation) or "false alarm" to the Lures (via pattern completion). The theoretical range for this outcome is -1 to 1 with higher scores indicating better memory function.
次要结局
- Amyloid Positron Emission Tomography (PET) Scan as a Measure of Tracer Binding (SUVr)(Baseline and Follow-up at 6 months)
- Single-stage Treadmill Test(Baseline and Follow-up at 6 months)
- Modified Physical Function Test(Baseline and Follow-up at 6 months)
- Brain-derived Neurotropic Factor (BDNF) as a Measure From Blood(Baseline and Follow-up at 6 months)
研究者
Judy Pa
Assistant Professor of Neurology
University of Southern California