Clinical trial NCT06027320: The Retain Your Brain Health Study (RetainYourBrain.com)
Official title: Risk Education Technology As Individualized Neuroprotection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Dementia
Healthy Participants
Brain Health
Keywords: Alzheimer's
Prevention
Clinical Trial
Lead sponsor: Retain Health, Inc
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-09-07
Enrollment: 992
Sex: ALL
Minimum age (years): 53
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Australian National University Alzheimer's Disease Risk Index (ANU-ADRI)
timeFrame: Baseline, 3 months and 6 months.
Secondary outcomes:
measure: Cogstate Brief Battery
timeFrame: Baseline, 3 months and 6 months.
measure: Fear of Alzheimer's Disease Scale
timeFrame: Baseline, 3 months and 6 months.
Other outcomes:
measure: User Satisfaction
timeFrame: 3 months and 6 months.
measure: Costs or savings associated with using the online software application
timeFrame: 3 months and 6 months.
Locations:
city: Bedford
country: United States
facility: Retain Health, Inc.
state: Massachusetts
Study officials:
affiliation: Retain Health, Inc
name: Tammie Elgammal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cincinnati School of Medicine
name: Robert Krikorian, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Retain Health, Inc
name: Mark McInnis, BA
role: PRINCIPAL_INVESTIGATOR
References: