The Retain Your Brain Health Study (RetainYourBrain.Com)

Alzheimer Disease Clinical Trial

Official title:

Risk Education Technology As Individualized Neuroprotection

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06027320
• Other study ID #: 20216157
• Secondary ID: 4R44AG071416
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 7, 2023
• Est. completion date: September 7, 2024

Study information

• Verified date: December 2023
• Source: Retain Health, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 736
• Est. completion date: September 7, 2024
• Est. primary completion date: September 7, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 53 Years to 105 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Brain Health
• Dementia
• Healthy Participants

Intervention

Behavioral:
• Brain Health Education
Subjects will receive an Alzheimer's risk assessment, memory testing, and brain health education, in addition to text message communication.
• 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.

Locations

Country	Name	City	State
United States	Retain Health, Inc.	Bedford	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Retain Health, Inc	National Institute on Aging (NIA), University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	User Satisfaction	A brief questionnaire will be given to understand how satisfied an individual is with the online software application.	3 months and 6 months.
Other	Costs or savings associated with using the online software application	A brief questionnaire will be given to determine if there are any costs or savings associated with using the online software application for brain health education.	3 months and 6 months.
Primary	Australian National University Alzheimer's Disease Risk Index (ANU-ADRI)	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.	Baseline, 3 months and 6 months.
Secondary	Cogstate Brief Battery	The Cogstate Brief Battery (CBB) is a short, internet-based, self-administered cognitive test consisting of four tasks that measure the following cognitive domains: attention, processing speed, learning and working memory. The CBB was developed to detect cognitive changes in the pre-symptomatic stages of AD.; Psychomotor function is measured by speed of performance (mean of the log10 transformed reaction times for correct responses). Attention is measured by speed of performance (mean of the log10 transformed reaction times for correct responses). Visual learning is measured by accuracy of performance (arcsine transformation of the square root of the proportion of correct responses). Working memory is measured as a speed of performance (mean of the log10 transformed reaction times for correct responses); accuracy of performance (arcsine transformation of the square root of the proportion of correct responses).	Baseline, 3 months and 6 months.
Secondary	Fear of Alzheimer's Disease Scale	The FADS is a self-report 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 FADS, and worrisome attitudes associated with FADS. In this study, only the general fear subscale will be used with lower scores meaning less fear of Alzheimer's Disease (with 17 being the lowest score and 85 the highest.)	Baseline, 3 months and 6 months.

External Links

•   RetainYourBrain Page