The Retain Your Brain Health Study (RetainYourBrain.com)

NCT06027320 | Completed DMC

• 2 other identifiers: 202161574R44AG071416
• Study Type: interventional
• Target: 992
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease; Dementia; Healthy Participants; Brain Health

Keywords

Alzheimer's; Prevention; Clinical Trial

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 3 months and 6 months.

Secondary Outcomes (2)

• Cogstate Brief Battery

  Baseline, 3 months and 6 months.

• Fear of Alzheimer's Disease Scale

  Baseline, 3 months and 6 months.

Other Outcomes (2)

• User Satisfaction

  3 months and 6 months.

• Costs or savings associated with using the online software application

  3 months and 6 months.

Study Arms (2)

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.

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.

Behavioral: Alzheimer Disease Education

Interventions

Brain Health Education BEHAVIORAL

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

Brain Health Education Arm

Alzheimer Disease Education BEHAVIORAL

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

Alzheimer Disease Education Arm

Eligibility Criteria

• Age: 53 Years - 105 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Retain Health, Inc: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Retain Health, Inc.

Bedford, Massachusetts, 01730, United States

Location

Related Links

• RetainYourBrain Page

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: September 7, 2023
• Study Start: December 7, 2023
• Primary Completion: September 16, 2024
• Study Completion: September 16, 2024
• Last Updated: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

US (1)