Alzheimer DiseaseNCT06027320
The Retain Your Brain Health Study (RetainYourBrain.com)
A study testing Brain Health Education and Alzheimer Disease Education in people with Alzheimer Disease and Dementia, run by Retain Health, Inc at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 53 to 105 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Dementia, Healthy Participants
- What is being tested?
- Brain Health Education and Alzheimer Disease Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 992 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2023to 16 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 53 to 105 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk Education Technology As Individualized Neuroprotection
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.
Read the 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.
- Conditions
- Alzheimer Disease, Dementia, Healthy Participants, Brain Health
- Being tested
- Brain Health Education, Alzheimer Disease Education
- Keywords
- Alzheimer's, Prevention, Clinical Trial
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Health EducationBehavioural
Subjects will receive an Alzheimer's risk assessment, memory testing, and brain health education, in addition to text message communication.
Alzheimer Disease EducationBehavioural
Subjects will receive an Alzheimer's risk assessment, memory testing, and general education about Alzheimer's disease, in addition to text message communication.
| Study group | Role | What they receive |
|---|---|---|
| Brain Health Education Arm | Experimental | Subjects will receive an Alzheimer's risk assessment, memory testing, and brain health education, in addition to text message communication. Receives: Behavioral: Brain Health Education |
| Alzheimer Disease Education Arm | Other | Subjects will receive an Alzheimer's risk assessment, memory testing, and general education about Alzheimer's disease, in addition to text message communication. Receives: Behavioral: Alzheimer Disease Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 months and 6 months.
Secondary outcomes (2)
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).
Measured: Baseline, 3 months and 6 months.
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.)
Measured: Baseline, 3 months and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start7 Dec 2023
- Primary completion16 Sep 2024
- Study completion16 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 992 participants (actual)
Sponsor and investigators
- Lead sponsor
- Retain Health, Inc
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Tammie Elgammal, MD, Principal investigator, Retain Health, IncRobert Krikorian, PhD, Principal investigator, University of Cincinnati School of MedicineMark McInnis, BA, Principal investigator, Retain Health, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06027320
- Sponsor's protocol ID
- 20216157
- Other IDs
- 4R44AG071416
- Status last verified
- Oct 2024
- First submitted
- 25 Aug 2023
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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 Investigators, and the data will be made available to qualified researchers via a secure portal.
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Education Technology As Individualized Neuroprotection
- ClinicalTrials.gov ID
- NCT06027320
- Acronym / sponsor ID
- 20216157
- Conditions
- Alzheimer Disease, Dementia, Healthy Participants, Brain Health
- Keywords
- Alzheimer's, Prevention, Clinical Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 992 participants (actual)
- Lead sponsor
- Retain Health, IncUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 7 Dec 2023 (actual)
- Primary completion
- 16 Sep 2024 (actual)
- Study completion
- 16 Sep 2024 (actual)
- First posted
- 7 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brain Health Education Arm | Experimental | Behavioral: Brain Health EducationSubjects will receive an Alzheimer's risk assessment, memory testing, and brain health education, in addition to text message communication. |
| Alzheimer Disease Education Arm | Other | Behavioral: Alzheimer Disease EducationSubjects will receive an Alzheimer's risk assessment, memory testing, and general education about Alzheimer's disease, in addition to text message communication. |
Who may qualify
- Ages
- 53 to 105 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain Health EducationSubjects will receive an Alzheimer's risk assessment, memory testing, and brain health education, in addition to text message communication. | Behavioural | Brain Health Education Arm |
| Alzheimer Disease EducationSubjects will receive an Alzheimer's risk assessment, memory testing, and general education about Alzheimer's disease, in addition to text message communication. | Behavioural | Alzheimer Disease Education Arm |
Primary outcome
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.
2 secondary outcomes
Cogstate Brief Battery
Time frame: Baseline, 3 months and 6 months.
Fear of Alzheimer's Disease Scale
Time frame: Baseline, 3 months and 6 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- RetainYourBrain PageLink provided by the sponsor.
- Individual participant dataSharing planned: 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 Investigators, and the data will be made available to qualified researchers via a secure portal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain Health Education and Alzheimer Disease Education in people with Alzheimer Disease and Dementia, run by Retain Health, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Australian National University Alzheimer's Disease Risk Index (ANU-ADRI) (time frame: Baseline, 3 months and 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2024.