Recruiting

BRAIN App

Sponsor:

Hopeful Aging

Code:

NCT06298474

Conditions

Dementia

Alzheimer Disease

Vascular Dementia

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

The BRAIN App

Study Details

Brief summary:

There are currently 6.7 million Americans living with dementia and, without significant breakthroughs, this figure will double to 12.7 million by 2050. There are about 46,000 long-term care (LTC) facilities in the U.S. More than half of LTC residents have some form of dementia (Alzheimer's Association, 2018). Responsive behaviors and dysfunction of the dementia care triad-i.e., the PLWD, professional Care Partner (CP), and Family Member (FM)-are inexorably linked. The emergence of responsive behaviors can lead to disruption of the triad's function. Thus, it is imperative to maintain positive relationships and a high quality of life (QoL) within the triad to reduce BPSD. Cognitive Stimulation Therapy (CST) has demonstrated improvements in QoL and relationships for PLWD. CST is a psychosocial intervention that promotes communication and engagement in PLWD via a structured program of meaningful and enjoyable theme. While clinical trials have shown improvement in cognition and QoL, the potential large-scale impact of CST has been hampered by low adherence, with less than 40% completing trials. One likely reason for the low adherence to CST is the reliance on generic and non-digital tools (e.g., paper-based agendas, tools, DVDs, and board games) in facilitating the intervention. That is, even though CST aims to be personalized, the specific interventions used in the field tend to be generic and not tailored to each PLWD's specific interests. The use of digital technology to implement CST would offer considerable advantages to expand and personalize the range of stimulation content and provide a means for monitoring responses, optimizing protocols, and promoting adherence.

The proposed Phase II study will involve the continued development and evaluation of a multi-faceted software platform called "Building Relationships using Artificial Intelligence and Nostalgia" or BRAIN. The BRAIN Platform will be the first-ever Artificial Intelligence (AI) powered CST digital therapy platform for PLWD. The platform, which has been shown to be effective in an initial Phase I clinical trial, has three main goals: to improve the quality of life of PLWD, to reduce BPSD in PLWD, and to foster positive relationships between members of the care triad. The proposed Phase II project has the following Specific Aims: 1. Create an improved Beta version of the BRAIN Platform's eight components: (1) the Admin Management Dashboard, (2) the Annotation Dashboard, (3) the Log Viewer, (4) the Content Management System (CMS), (5) the Private CMS, (6) the Control App, (7) the Home App, and (8) the Training Dashboard. 2. Fine-tune the different classes of AI algorithms-i.e., behavioral analytics, personalized content recommendation, and personalized program generation-in the BRAIN app such that they can (a) recognize and track 12 distinct behaviors and indicators of PLWD, (b) use these behavioral traits as a basis for automatically rating the relative success of each activity, and (c) automatically recommend personalized activities that are likely to be successful for individual PLWD. 3. Conduct a Cluster Randomized Trial (CRT) of the BRAIN App to examine the app's impact on engagement/affect, quality of life, and responsive behaviors. 4. Examine satisfaction and ease of use of the app for PLWD, LTC staff, and FMs.

Conditions

Dementia

Alzheimer Disease

Vascular Dementia

Study ID

NCT06298474

Start date

May 15, 2025

Status verified date

Jun, 2025

Completion date

Jul 30, 2026

Anticipated

Primary completion date

Jun 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 65+ years old
  • Clinical diagnosis of dementia (any type)
  • Able to speak conversational English

Exclusion Criteria:

  • Completely unable to communicate verbally
  • Serious visual or hearing impairments
  • Signs of rapid decline over the last three months (based upon staff report)

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental, BRAIN Programming

PLWD in the Experimental Group will be invited to use the BRAIN intervention twice per week for 3 months. Each session is expected to last 20-30 minutes. The BRAIN app will initially recommend activities for each PLWD based upon his/her background/interests/preferences, which will be collected when the PLWD first enrolls in the study. After the initial sessions, the BRAIN app will use AI to recommend new activities for subsequent sessions. These recommendations will be based upon the AI's rating of the relative success or failure of the activities initially provided to the PLWD.

no intervention: Control: Standard Programming / Care

PLWD in the Control Group will participate in standard care / programming for 3 months.

Interventions

The BRAIN App

The BRAIN App is digital engagement platform that uses AI to tailor activities to each person's specific interests / background.

Primary outcome measure

  • Menorah Park Engagement Scale (MPES) [ Time Frame: Baseline, that is, Weeks 1 - 4 ]
  • Menorah Park Engagement Scale (MPES) [ Time Frame: Intervention Period, that is, Weeks 5-16 ]
  • Engagement for Persons with Dementia Scale (EPWDS) [ Time Frame: Baseline, that is, Weeks 1 - 4 ]
  • Engagement for Persons with Dementia Scale (EPWDS) [ Time Frame: Baseline, that is, Weeks 5-16 ]

Central Contacts and Locations

Locations

Hopeful Aging

Recruiting

Winchester, Massachusetts, United States, 01890

Contacts

More Information

Sponsor

Hopeful Aging

Last update posted

Jun 19, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hopeful Aging on 2025-06-19.