History of Changes for Study: NCT06027320

The Retain Your Brain Health Study (RetainYourBrain.Com)

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Study Record Versions

Version	Submitted Date	Changes
1	August 30, 2023	None (earliest Version on record)
2	December 7, 2023	Recruitment Status, Outcome Measures, Study Status, Arms and Interventions, Study Design, Study Description, IPDSharing, Contacts/Locations, Eligibility and Conditions
3	March 24, 2024	Recruitment Status, Contacts/Locations and Study Status

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	20216157
Brief Title:	The Retain Your Brain Health Study (RetainYourBrain.Com)
Official Title:	Risk Education Technology As Individualized Neuroprotection
Secondary IDs:	4R44AG071416 [U.S. NIH Grant/Contract]

Study Status


Record Verification:	August 2023
Overall Status:	Not yet recruiting
Study Start:	October 2, 2023
Primary Completion:	July 2, 2024 [Anticipated]
Study Completion:	January 2, 2025 [Anticipated]

First Submitted:	August 25, 2023
First Submitted that Met QC Criteria:	August 30, 2023
First Posted:	September 7, 2023 [Actual]

Last Update Submitted that Met QC Criteria:	August 30, 2023
Last Update Posted:	September 7, 2023 [Actual]

Sponsor/Collaborators


Sponsor:	Retain Health, Inc
Responsible Party:	Sponsor
Collaborators:	National Institute on Aging (NIA) University of Cincinnati

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	No
Data Monitoring:	Yes

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.

Conditions


Conditions:	Alzheimer Disease Dementia Healthy Participants Brain Health
Keywords:	Alzheimer's prevention Clinical Trial

Study Design


Study Type:	Interventional
Primary Purpose:	Prevention
Study Phase:	Not Applicable
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	Triple (Participant, Care Provider, Investigator)
Allocation:	Randomized
Enrollment:	736 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
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.
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:
1.	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.
Secondary Outcome Measures:
1.	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.
2.	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.
Other Outcome Measures:
1.	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.
2.	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.

Eligibility


Minimum Age:	53 Years
Maximum Age:	105 Years
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	Yes
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.

Contacts/Locations


Central Contact Person:	Tammie Elgammal, MD Telephone: 561-320-3507 Email: tammie@retainhealth.com
Central Contact Backup:	Mark McInnis, BA Telephone: 781-222-8053 Email: mmcinnis@retainhealth.com
Study Officials:	Tammie Elgammal, MD Principal Investigator Retain Health, Inc
	Robert Krikorian, PhD Principal Investigator University of Cincinnati School of Medicine
	Mark McInnis, BA Principal Investigator Retain Health, Inc
Locations:

IPDSharing


Plan to Share IPD:	Yes 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.
	Supporting Information: Study Protocol 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

References


Citations:
Links:	URL: http://www.RetainYourBrain.com Description: RetainYourBrain Page
Available IPD/Information: