An interventional study of LifeBio Memory (LBM) digital reminiscence intervention in Mild Cognitive Impairment, sponsored by George Mason University. Not yet recruiting. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by George Mason University · Not applicable, Interventional, and Prevention
LifeBioMEMORY (LBM) is a reminiscence therapy (RT) mobile application that captures older adults' life stories in their own voices to promote social engagement and psychosocial well-being. This study will develop and evaluate an enhanced multilingual LBM app for community-dwelling, diverse older adults with mild cognitive impairment (MCI) or at risk of MCI and their informal caregivers, including Hispanic/Latino, Asian American (as one of subgroups, Korean), Black or African American, and non-Hispanic White populations. The app provides culturally tailored life story prompts with audio and visual cues to encourage reminiscence and storytelling. The intervention aims to improve quality of life, reduce depressive symptoms and loneliness, and strengthen caregiver-care recipient relationships, with the potential to provide an accessible, non-pharmacological approach to supporting cognitive and emotional well-being.
Alzheimer's Disease and Related Dementias (ADRD) are becoming more prevalent in the United States. It is expected that the number of people affected will increase to 7.2 million by 2025 and 11.2 million by 2040. This is accompanied by a staggering cost of care, amounting to $345 billion annually in the US alone, with Medicare and Medicaid accounting for $222 billion of that amount. Globally, the cost of dementia is estimated to be over $1.3 trillion in 2021, and it is expected to rise to $2.8 trillion by 2030.
The effectiveness of LifeBioMEMORY (LBM) technology has shown promise in increasing engagement and social support through life story capture and RT opportunities among institutionalized older adults with cognitive impairment and formal caregivers. More than 1,000 individuals have been voice recorded in nursing home or residential living settings as a result of LBM Phase II SBIR grant. LBM's Phase IIB renewal application is to continue research and development and to advance toward further commercialization, with NIA's commitment to funding R\&D for interventions for prevention or treatment of MCI and ADRD. With LMM Phase IIB based on RT and now capturing life stories in older adults' own voices, the investigtors propose to build and then validate an enhanced multi-language version of the LBM app with a diverse, non-institutionalized population to investigate linguistic and cultural appropriateness, focusing on Hispanic/Latinx, Asian American (as one of subgroups, Korean), Black or African-American, and non-Hispanic White older adults with MCI or at risk of MCI and their informal caregivers.
The specific aims of this SBIR application are to: 1) Update the LBM for culturally relevant multi-lingual support, 2) Assess its usability, and 3) Evaluate its feasibility, acceptability, and initial efficacy through a randomized waitlist-controlled trial using a mixed methods approach among diverse racial and ethnic dyads, each consisting of an older adult participant (with MCI or at risk of MCI) and an informal caregiver. This involves 84 older adult participants and 84 informal caregivers, including 21 Hispanic/Latinx, 21 Korean, 21 Black or African American, and 21 non-Hispanic White dyads. Outcomes such as health-related quality of life, depression, relationship closeness, and loneliness will be measured at baseline, 4 weeks post-follow-up, and 12 weeks post-follow-up. Additionally, user activities and qualitative interviews will be used to understand user experience, leading to recommended changes to the LBM interface by LifeBio as a result of Aims 2 and 3.
The investigators will enroll a total of 84 older adult participants and 84 informal caregivers across the 84 dyads, comprising 21 Hispanic/Latino dyads, 21 Korean dyads, 21 Black dyads, and 21 Non-Hispanic White dyads.
The inclusion and exclusion criteria for older adult participants are:
The inclusion and exclusion criteria for informal caregivers are:
Participants will access the LifeBio Memory (LBM) digital reminiscence platform using a mobile phone or tablet. Informal caregivers will complete a brief training. During Weeks 1-2, dyads will complete at least two weekly sessions recording the older adult's life stories using structured prompts. During Weeks 3-5, dyads will complete one weekly reminiscence and social engagement session. In Week 6, participants will receive personalized LifeBio story materials, including a Life Story Book, Snapshot, and story summary.
Other: LifeBio Memory (LBM) digital reminiscence intervention
Participants will receive general education on brain health and information about available local social services during the control period. After the control period, participants will participate in the LifeBio Memory (LBM) App intervention.
Other: LifeBio Memory (LBM) digital reminiscence intervention
LifeBioMEMORY (LBM) is a multilingual digital reminiscence therapy platform that guides older adults through life story sharing using culturally relevant prompts, photos, and voice recording in Spanish, Korean, or English. The app includes "My Story" and "Fun Things to Do" features to support reminiscence and engagement while capturing personal narratives. Using machine learning, LBM generates personalized Life Story Books and summaries in the preferred language of the older adult and informal caregiver, with electronic and printed copies available. The intervention is designed to promote social engagement, strengthen caregiver relationships, and support person-centered care.
Primary Outcome
Health-Related Quality of Life (SF-12 Physical and Mental Component Summary Scores)
Time frame: Assessments will be conducted at baseline, 6 weeks, and 10 weeks.
Center for Epidemiologic Studies Depression Scale (CES-D)
The Center for Epidemiologic Studies Depression Scale (CES-D) measures depressive symptoms. Total scores range from 0 to 60, with higher scores indicating greater depressive symptoms (worse outcome).
Time frame: Assessments will be conducted at baseline, 6 weeks, and 10 weeks.
Relationship Closeness Scale (RCS)
The Relationship Closeness Scale (RCS) measures perceived emotional closeness and relationship quality between the caregiver and care recipient. Total scores range from 6 to 24, with higher scores indicating greater relationship closeness (better outcome).
Time frame: Assessments will be conducted at baseline, 6 weeks, and 10 weeks.
UCLA Loneliness Scale
The 3-Item UCLA Loneliness Scale (UCLA-LS-3) measures perceived loneliness and social isolation. Total scores range from 3 to 9, with higher scores indicating greater loneliness (worse outcome).Time Frame: Assessments will be conducted at baseline, 6 weeks, and 10 weeks.
Time frame: Assessments will be conducted at baseline, 6 weeks, and 10 weeks.
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
George Mason University