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The Retain Your Brain Health Study (RetainYourBrain.Com)

Primary Purpose

Alzheimer Disease, Dementia, Healthy Participants

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Brain Health Education
Alzheimer Disease Education
Sponsored by
Retain Health, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alzheimer Disease focused on measuring Alzheimer's, prevention, Clinical Trial

Eligibility Criteria

53 Years - 105 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 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: having 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 <18.5kg/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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Brain Health Education Arm

    Alzheimer Disease Education Arm

    Arm Description

    Subjects will receive an Alzheimer's risk assessment, memory testing and brain health education, in addition to text message communication.

    Subjects will receive an Alzheimer's risk assessment, memory testing and general education about Alzheimer's disease, in addition to text message communication.

    Outcomes

    Primary Outcome Measures

    Australian National University-AD 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.

    Secondary Outcome Measures

    Cogstate Brief Battery (CBB)
    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)
    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.

    Full Information

    First Posted
    August 25, 2023
    Last Updated
    August 30, 2023
    Sponsor
    Retain Health, Inc
    Collaborators
    National Institute on Aging (NIA), University of Cincinnati
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06027320
    Brief Title
    The Retain Your Brain Health Study (RetainYourBrain.Com)
    Official Title
    Risk Education Technology As Individualized Neuroprotection
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2, 2023 (Anticipated)
    Primary Completion Date
    July 2, 2024 (Anticipated)
    Study Completion Date
    January 2, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Retain Health, Inc
    Collaborators
    National Institute on Aging (NIA), University of Cincinnati

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alzheimer Disease, Dementia, Healthy Participants, Brain Health
    Keywords
    Alzheimer's, prevention, Clinical Trial

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    736 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Brain Health Education Arm
    Arm Type
    Experimental
    Arm Description
    Subjects will receive an Alzheimer's risk assessment, memory testing and brain health education, in addition to text message communication.
    Arm Title
    Alzheimer Disease Education Arm
    Arm Type
    Other
    Arm Description
    Subjects will receive an Alzheimer's risk assessment, memory testing and general education about Alzheimer's disease, in addition to text message communication.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Brain Health Education
    Intervention Description
    Subjects will receive an Alzheimer's risk assessment, memory testing and brain health education, in addition to text message communication.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Alzheimer Disease Education
    Intervention Description
    Subjects will receive an Alzheimer's risk assessment, memory testing and general education about Alzheimer's disease, in addition to text message communication.
    Primary Outcome Measure Information:
    Title
    Australian National University-AD Risk Index (ANU-ADRI)
    Description
    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.
    Time Frame
    Baseline, 3 and 6 month.
    Secondary Outcome Measure Information:
    Title
    Cogstate Brief Battery (CBB)
    Description
    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.
    Time Frame
    Baseline, 3 and 6 month.
    Title
    Fear of Alzheimer's Disease Scale (FADS)
    Description
    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.
    Time Frame
    Baseline, 3 and 6 month.
    Other Pre-specified Outcome Measures:
    Title
    User Satisfaction
    Description
    A brief questionnaire will be given to understand how satisfied an individual is with the online software application.
    Time Frame
    3 and 6 month.
    Title
    Cost Effectiveness
    Description
    A brief questionnaire will be given to analyze if there are any costs associated with using the online software application.
    Time Frame
    3 and 6 month.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    53 Years
    Maximum Age & Unit of Time
    105 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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 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: having 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 <18.5kg/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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tammie Elgammal, MD
    Phone
    561-320-3507
    Email
    tammie@retainhealth.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mark McInnis, BA
    Phone
    781-222-8053
    Email
    mmcinnis@retainhealth.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tammie Elgammal, MD
    Organizational Affiliation
    Retain Health, Inc
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Robert Krikorian, PhD
    Organizational Affiliation
    University of Cincinnati School of Medicine
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Mark McInnis, BA
    Organizational Affiliation
    Retain Health, Inc
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing 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 Investigator and the data will be made available to qualified researchers via a secure portal.
    IPD Sharing Time Frame
    Six-months after publication of full study results.
    IPD Sharing Access Criteria
    Data will be made available to qualified researchers via a secure portal.
    IPD Sharing URL
    http://www.RetainYourBrain.com
    Links:
    URL
    http://www.RetainYourBrain.com
    Description
    RetainYourBrain Page

    Learn more about this trial

    The Retain Your Brain Health Study (RetainYourBrain.Com)

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