The Impact of Weight Loss on Alzheimer's Disease Risk in Adults With Down Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Neurofilament light
研究概览
简要总结
The goal of this study is to determine if weight loss or changes in dietary intake can help prevent of delay adults with Down syndrome from developing Alzheimer's Disease
Adults with Down syndrome without dementia will be randomized to either a weight loss group or a general health education control group. The weight loss group will be asked to follow a reduced energy diet, attend monthly education sessions delivered remotely and self-monitor diet and body weight using commercially available web-based applications. The control group will be asked to attend remotely delivered monthly education sessions on general health education topics.
All participants will come to the University of Kansas Medical Center, 3 times across 12 months for a blood draw, cognitive testing, a MRI, assessment of height and weight, and assessment of diet intake.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Down syndrome
- •BMI of 25 to 50 kg/m2
- •Ability to communicate through spoken language.
- •Ability to come to the University of Kansas Medical Center 3 times across 1 year for outcomes testing
- •Living at home with a parent/guardian, or in a supported living environment with a caregiver who assists with food shopping, meal planning, and meal preparation and agrees to serve as a study partner including providing transportation to our facilities for study assessments.
排除标准
- •Diagnosis of dementia
- •Insulin dependent diabetes
- •Participation in a weight management program involving diet or physical activity in the past 6 mos.
- •Dairy allergy
- •Serious medical risk (e.g., cancer, recent heart attack, stroke, pregnancy, angioplasty)
- •Unwilling to be randomized
- •Contraindications for MRI, including metal implants or devices incompatible with MRI such as pacemakers, claustrophobia, and inability to lay in a supine position
- •Use of GLP-1 medications
- •Use of anti-amyloid medications
研究组 & 干预措施
Weight Loss
- Follow a reduced calorie diet daily for 12 months.
- Attend monthly behavioral counseling/education
干预措施: Diet (Behavioral)
Weight Loss
- Follow a reduced calorie diet daily for 12 months.
- Attend monthly behavioral counseling/education
干预措施: Health Education (Behavioral)
General Health Education Control
- Attend monthly health education sessions about general health.
干预措施: Health Education (Behavioral)
结局指标
主要结局
Neurofilament light
时间窗: Baseline, 6, 12 months
Examines the amount of Neurofilament light in a person's brain, measured by a blood draw.
Plasma Amyloid beta 42:40 ratio
时间窗: Baseline, 6, 12 months
Examines the amount of amyloid beta in a person's brain, measured by a blood draw.
Weight
时间窗: Baseline, 6, 12 months
Examines how much a person weights, measured by standing on a scale.
次要结局
- Dietary Intake(Baseline, 6, 12 months)
- Skin carotenoid content(Baseline, 6, 12 months)
- Plasma Phosphorylated Tau(Baseline, 6, 12 months)
- Glial Fibrillary Acidic Protein(Baseline, 6, 12 months)
- Brian Volume(Baseline, 12 months)
- Brain antioxidants(Baseline, 12 months)
- The modified Cued Recall Test(Baseline, 6, 12 months)
- The Modified Cats and Dogs Task(Baseline, 6, 12 months)
- Down Syndrome Mental Status Examination(Baseline, 6, 12 months)