跳至主要内容
临床试验/NCT06027320
NCT06027320已完成不适用

Risk Education Technology As Individualized Neuroprotection

Retain Health, Inc2 个研究点 分布在 1 个国家目标入组 992 人开始时间: 2023年12月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
992
试验地点
2
主要终点
Australian National University Alzheimer's Disease Risk Index (ANU-ADRI)

研究概览

简要总结

The goal of this clinical trial is to test a cell phone-based online program that provides Alzheimer's risk assessments and memory tests over a 6-month period. The main question it aims to answer is whether online software can help reduce the risk of Alzheimer's disease (AD) through digital education and tracking.

Participants will visit RetainYourBrain.com to answer questions about their risk factors for AD and take online word recall and card game cognitive tests. Researchers will track progress over time and compare different strategies of Alzheimer's education to see if it is possible to protect brain health, reduce Alzheimer's risk, and improve memory function.

详细描述

Alzheimer's disease (AD) is a public health crisis with few effective treatments. Most people are unaware that AD begins in the brain decades before the first symptoms of memory loss begin. That leaves a lot of time for people to learn their individual risk factors for AD and cognitive decline and take memory assessment screening tests in an effort toward the prevention or delay of dementia. To reach a growing at-risk population, mobile health technologies accessible via cell phone can fill an unmet need due to their accessibility and cost-effective delivery of care. Online education and text messaging have proven to be effective methods of reducing risk for a variety of chronic conditions, including cardiovascular disease and diabetes, which are both key drivers of AD risk.

The investigators created a cell phone-based online software application to provide automated, individualized monitoring and education at broad scale. The goal of the software is to function as a digital therapeutic to identify individual risk factors, assess memory and cognitive function over time, and provide education to people with a family history of AD. The system maintains bi-directional communication via text message to verify participant engagement.

Potential participants who visit our study website (www.RetainYourBrain.com) will be directed to answer questions assessing eligibility criteria. Participants who are eligible are asked to electronically sign an informed consent form, complete baseline assessments, and take online word recall and card game cognitive tests. Participants will then be randomized to one of two groups using different strategies for AD risk assessment education. Researchers will track progress over six months and compare different strategies of education to determine if it is possible to protect brain health, reduce Alzheimer's risk, and improve memory function.

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, Outcomes Assessor)

入排标准

年龄范围
53 Years 至 105 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • be at least 53 years of age
  • have a family history of Alzheimer's Disease (AD)
  • have a compatible phone/device (phone allowing text messages and with internet access, and/or tablet device with the same capabilities)
  • a minimum of one of the following risk factors: body mass index (BMI) of < 25 kg/m2, history of pre-diabetes/diabetes, high blood pressure, high cholesterol, smoking, low physical activity, low fish intake (< 3 times per month), high alcohol intake (< 7 servings per week for a women and <14 servings a week for men), diagnosed with mild or moderate depression.

排除标准

  • have a diagnosis of dementia due to AD
  • other dementia
  • women who are currently pregnant or who plan on becoming pregnant in the next 6 months
  • BMI <18.5 kg/m2
  • consuming >35 alcoholic drinks/week for men or >28 alcoholic drinks/week for women
  • severe depression (PHQ-9 score of more than 15)
  • current treatment for cancer
  • diagnosis of Parkinson's disease, amyotrophic lateral sclerosis, Lewy body dementia, frontotemporal disorders, multiple sclerosis, or other neurodegenerative disease
  • current treatment for an eating disorder
  • currently prescribed insulin for type I or II diabetes
  • inability to give informed consent or complete identity verification
  • participating in another AD trial.

结局指标

主要结局

Australian National University Alzheimer's Disease Risk Index (ANU-ADRI)

时间窗: Baseline, 3 months and 6 months.

The ANU-ADRI is an evidence-based, validated tool aimed at assessing individual exposure to risk factors known to be associated with an increased risk of developing late-life Alzheimer's Disease (AD). The ANU-ADRI provides an individualized assessment and has been used in studies aiming to evaluate methods of reducing AD risk.

次要结局

  • Cogstate Brief Battery(Baseline, 3 months and 6 months.)
  • Fear of Alzheimer's Disease Scale(Baseline, 3 months and 6 months.)

研究者

发起方
Retain Health, Inc
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验