The BRAIN App for Dementia

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Hopeful Aging

Disqualifiers: Non-verbal, Visual/hearing impairments, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 15

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using a digital app for therapy, so it's likely you can continue your medications, but please confirm with the trial coordinators.

How is The BRAIN App treatment different from other dementia treatments?

The BRAIN App is unique because it uses mobile technology to provide cognitive enhancement and delay cognitive decline in people with dementia, offering activities like games and reminders that are tailored to individual needs, unlike traditional treatments that may not be as personalized or interactive. ^{1 2 3 4 5}

What data supports the effectiveness of The BRAIN App treatment for dementia?

Research suggests that mobile health apps, like The BRAIN App, can help slow down cognitive decline in people with dementia by offering cognitive exercises and assessments. Additionally, using games to train cognitive skills has been shown to be a successful approach for people with dementia. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals aged 65 or older who have been diagnosed with any type of dementia and can speak conversational English. It's not suitable for those who've shown rapid decline in the last three months, cannot communicate verbally at all, or have serious visual or hearing impairments.

Exclusion Criteria

My health has quickly worsened over the past three months.

I cannot speak at all.

I have serious issues with my vision or hearing.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Data Collection

Data related to demographics, medications, diagnoses, and type of dementia will be collected. Various assessments will be administered to PLWD.

4 weeks

12 observations (in-person)

Intervention

PLWD will use the BRAIN app three times per week for 3 months. Activity sessions will be implemented by Nursing Assistants and family members.

12 weeks

3 sessions per week (in-person)

Post-Treatment Data Collection

Assessments such as MMSE, DEMQOL, GDS-SF, and NPI-NH will be implemented again to investigate long-term effects.

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• The BRAIN App

Trial Overview The BRAIN App is being tested to see if it improves quality of life, reduces behavioral symptoms, and enhances relationships within the care triad (person living with dementia, professional caregiver, family member) using AI-powered Cognitive Stimulation Therapy.

How Is the Trial Designed?

Group I: Experimental, BRAIN Programming Experimental Treatment 1 Intervention

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.

Group II: Control: Standard Programming / Care Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Hopeful Aging

Lead Sponsor

Trials

6

Recruited

610+

Published Research Related to This Trial

Verbal-instruction technology significantly helped individuals with mild and moderate Alzheimer's disease perform daily activities, with seven out of nine participants showing accurate performance in tasks like snack preparation and shaving.

The intervention also positively impacted mood, as eight participants exhibited increased happiness or decreased unhappiness during the activities, suggesting that this approach can enhance both activity engagement and emotional well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Persons with mild and moderate Alzheimer's disease use verbal-instruction technology to manage daily activities: effects on performance and mood. Lancioni, G., Singh, N., O'Reilly, M., et al.[2022]

A survey of 48 participants, including people with cognitive impairment, caregivers, and healthcare professionals, revealed a strong interest in using mHealth apps to improve memory, assist with medication management, and enhance ease of use.

All groups involved believe that mHealth apps, particularly brain games and geolocation tracking, could significantly support dementia care and help manage cognitive decline, despite concerns about privacy from patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human Factors and Requirements of People with Cognitive Impairment, Their Caregivers, and Healthcare Professionals for mHealth Apps Including Reminders, Games, and Geolocation Tracking: A Survey-Questionnaire Study. Lazarou, I., Stavropoulos, TG., Mpaltadoros, L., et al.[2022]

A review of 83 mobile apps for elders with Alzheimer's and related dementias revealed that many apps focus on activities like games, music, and memory training, but often require high cognitive and physical abilities, such as eye-hand coordination.

To enhance engagement and positive experiences, it's important to adopt a person-centered approach when designing and selecting apps, considering the individual variability in cognitive and functional abilities among users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In Quest of Tablet Apps for Elders With Alzheimer's Disease: A Descriptive Review. Tak, SH.[2023]

The FindMyApps selection tool was developed through a user-participatory design process, involving collaboration between people with mild dementia, their caregivers, and experts, ensuring the tool meets the specific needs and abilities of its users.

Initial testing in iterative 'sprints' revealed important insights for improving the tool's usability, focusing on meaningful content and intuitive design, which are crucial for helping users select appropriate apps for managing their lives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

User-participatory development of FindMyApps; a tool to help people with mild dementia find supportive apps for self-management and meaningful activities. Kerkhof, Y., Pelgrum-Keurhorst, M., Mangiaracina, F., et al.[2023]

Citations

1. Netherlands pubmed.ncbi.nlm.nih.gov

Collecting Data from Senior Citizens Using Serious Games. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A Simple and Practical Index to Measure Dementia-Related Quality of Life. [2016]

3. England pubmed.ncbi.nlm.nih.gov

Persons with mild and moderate Alzheimer's disease use verbal-instruction technology to manage daily activities: effects on performance and mood. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Human Factors and Requirements of People with Cognitive Impairment, Their Caregivers, and Healthcare Professionals for mHealth Apps Including Reminders, Games, and Geolocation Tracking: A Survey-Questionnaire Study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Participant outcomes and preferences in Alzheimer's disease clinical trials: The electronic Person-Specific Outcome Measure (ePSOM) development program. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

A Survey of Mobile Apps for the Care Management of Patients with Dementia. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

In Quest of Tablet Apps for Elders With Alzheimer's Disease: A Descriptive Review. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

User-participatory development of FindMyApps; a tool to help people with mild dementia find supportive apps for self-management and meaningful activities. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Usability of tablet computers by people with early-stage dementia. [2022]