The Retain Your Brain Health Study (RetainYourBrain.Com)
Study Details
Study Description
Brief Summary
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 "card game" type 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 optimize memory function.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Alzheimer's disease (AD) is a public health crisis with few effective treatments. However, most people are unaware that AD begins in the brain decades before the first symptom of memory loss begins. 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 effort toward 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 accessibility and cost-effective delivery of care. Online education and text messaging has proven to be an effective method of reducing risk a variety of chronic conditions, such as cardiovascular disease and diabetes, which are both key drivers of AD risk.
We 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 functions as a digital therapeutic to identify individual risk factors, assess memory and cognitive function over time, and educate people with a family history of AD. The system maintains bi-directional communication via text message to verify user engagement.
Participants who visit our study website (www.RetainYourBrain.com) will be directed to answer questions assessing eligibility criteria. Participants who are eligible to participate are asked to electronically sign an informed consent, complete baseline assessments, and take a "card game" like memory test. 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 optimize memory function.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Brain Health Education Arm Subjects will receive an Alzheimer's risk assessment, memory testing and brain health education, in addition to text message communication. |
Behavioral: Brain Health Education
Subjects will receive an Alzheimer's risk assessment, memory testing and brain health education, in addition to text message communication.
|
| Other: Alzheimer Disease Education Arm Subjects will receive an Alzheimer's risk assessment, memory testing and general education about Alzheimer's disease, in addition to text message communication. |
Behavioral: Alzheimer Disease Education
Subjects will receive an Alzheimer's risk assessment, memory testing and general education about Alzheimer's disease, in addition to text message communication.
|
Outcome Measures
Primary Outcome Measures
- Australian National University-AD Risk Index (ANU-ADRI) [Baseline, 3 and 6 month.]
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.
Secondary Outcome Measures
- Cogstate Brief Battery (CBB) [Baseline, 3 and 6 month.]
Cognition will be measured by the Attention/Psychomotor composite score and the Learning/Working Memory composite from the CBB. The CBB is a brief, internet-based administered cognitive test consisting of four tasks that measure the following: attention, processing speed, learning and working memory. The CBB was developed to detect cognitive changes in the preclinical stages of AD.
- Fear of Alzheimer's Disease Scale (FADS) [Baseline, 3 and 6 month.]
The FADS is a self-reported valid instrument to directly address anticipatory dementia among a general population of older adults. It assesses 3 main topics: general fear of AD, physiological symptoms accompanying FAD, and catastrophic attitudes associated with FAD.
Other Outcome Measures
- User Satisfaction [3 and 6 month.]
A brief questionnaire will be given to understand how satisfied an individual is with the online software application.
- Cost Effectiveness [3 and 6 month.]
A brief questionnaire will be given to analyze if there are any costs associated with using the online software application.
Eligibility Criteria
Criteria
Inclusion Criteria:
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be at least 53 years of age
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have a family history of Alzheimer's Disease (AD)
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have a compatible phone/device (phone allowing text messages and with internet access, and/or tablet device with the same capabilities)
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a minimum of one of the following risk factors: body mass index (BMI) of more than 25 history of pre-diabetes/diabetes high blood pressure high cholesterol smoking low physical activity, less than 2 times per week low fish intake, less than 3 times per month high alcohol intake, more than 7 servings per week for a women and more than 14 servings a week for men diagnosed with mild or moderate depression
Exclusion Criteria:
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having a diagnosis of dementia due to AD
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other dementia
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women who are currently pregnant or who plan on becoming pregnant in the next 6 months
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BMI <18.5kg/m2
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consuming >35 alcoholic drinks/week for men or >28 alcoholic drinks/week for women
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severe depression (PHQ-9 score of more than 15)
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current treatment for cancer
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diagnosis of Parkinson's disease, amyotrophic lateral sclerosis, Lewy body dementia, frontotemporal disorders, multiple sclerosis, or other neurodegenerative disease
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current treatment for an eating disorder
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currently prescribed insulin for type I or II diabetes
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inability to give informed consent or complete identity verification
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participating in another AD trial.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Retain Health, Inc
- National Institute on Aging (NIA)
- University of Cincinnati
Investigators
- Principal Investigator: Tammie Elgammal, MD, Retain Health, Inc
- Principal Investigator: Robert Krikorian, PhD, University of Cincinnati School of Medicine
- Principal Investigator: Mark McInnis, BA, Retain Health, Inc
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 20216157
- 4R44AG071416