The Retain Your Brain Health Study (RetainYourBrain.Com)

• ClinicalTrials.gov Identifier: NCT06027320
• Recruitment Status: Active, not recruiting
• First Posted: September 7, 2023
• Last Update Posted: March 26, 2024
• Sponsor: Retain Health, Inc
• Collaborators: National Institute on Aging (NIA); University of Cincinnati
• Information provided by (Responsible Party): Retain Health, Inc

Tracking Information

• First Submitted Date: August 25, 2023
• First Posted Date: September 7, 2023
• Last Update Posted Date: March 26, 2024
• Actual Study Start Date: December 7, 2023
• Estimated Primary Completion Date: September 7, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 7, 2023)

Australian National University Alzheimer's Disease Risk Index (ANU-ADRI) [ Time Frame: 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.

Original Primary Outcome Measures (submitted: August 30, 2023)

Australian National University-AD Risk Index (ANU-ADRI) [ Time Frame: 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.

Current Secondary Outcome Measures (submitted: December 7, 2023)

• Cogstate Brief Battery [ Time Frame: Baseline, 3 months and 6 months. ]
  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).
• Fear of Alzheimer's Disease Scale [ Time Frame: Baseline, 3 months and 6 months. ]
  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.)

Original Secondary Outcome Measures (submitted: August 30, 2023)

• Cogstate Brief Battery (CBB) [ Time Frame: 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) [ Time Frame: 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.

Current Other Pre-specified Outcome Measures (submitted: December 7, 2023)

• User Satisfaction [ Time Frame: 3 months and 6 months. ]
  A brief questionnaire will be given to understand how satisfied an individual is with the online software application.
• Costs or savings associated with using the online software application [ Time Frame: 3 months and 6 months. ]
  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.

Original Other Pre-specified Outcome Measures (submitted: August 30, 2023)

• User Satisfaction [ Time Frame: 3 and 6 month. ]
  A brief questionnaire will be given to understand how satisfied an individual is with the online software application.
• Cost Effectiveness [ Time Frame: 3 and 6 month. ]
  A brief questionnaire will be given to analyze if there are any costs associated with using the online software application.

Descriptive Information

• Brief Title: The Retain Your Brain Health Study (RetainYourBrain.Com)
• Official Title: Risk Education Technology As Individualized Neuroprotection

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 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.

Detailed 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Prevention

Condition

• Alzheimer Disease
• Dementia
• Healthy Participants
• Brain Health

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.
• 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.

Study Arms

• 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.
  Intervention: Behavioral: Brain Health Education
• 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.
  Intervention: Behavioral: Alzheimer Disease Education

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: August 30, 2023): 736
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 7, 2024
• Estimated Primary Completion Date: September 7, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 53 Years to 105 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT06027320
• Other Study ID Numbers: 20216157; 4R44AG071416 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Data sharing is an essential part of our proposed activities. We intend to make our results available to the scientific community to contribute to knowledge of the field and avoid unintentional duplication of research. Data from this study will be placed in a research database. Proposals for research will be reviewed by the Principal Investigators, and the data will be made available to qualified researchers via a secure portal.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Time Frame: Six-months after publication of full study results.
• Access Criteria: Data will be made available to qualified researchers via a secure portal.
• URL: http://www.RetainYourBrain.com

• Current Responsible Party: Retain Health, Inc
• Original Responsible Party: Same as current
• Current Study Sponsor: Retain Health, Inc
• Original Study Sponsor: Same as current

Collaborators

• 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

• PRS Account: Retain Health, Inc
• Verification Date: December 2023