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?

This trial tests a new digital therapy app called the BRAIN App, designed for people living with dementia. The app uses artificial intelligence to suggest personalized activities that aim to improve quality of life and reduce challenging behaviors. Participants will use the app twice a week for three months, with the AI adjusting activities based on what works best for each person. Individuals diagnosed with dementia who can speak English and communicate verbally may be a good fit for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance daily living for those with dementia.

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.

What prior data suggests that the BRAIN App is safe for people living with dementia?

Research has shown that digital tools for dementia care, like the BRAIN App, are generally safe and easy for users to handle. Similar technology, such as the BrainTrack app, was developed with feedback from people living with or at risk of dementia, ensuring it is user-friendly and accepted. These tools aim to boost mental function and improve quality of life without causing harm.

The BRAIN App remains in the early testing stages. While it appears promising, more safety information is still being collected. It is designed to help people with dementia communicate and engage better, typically involving low-risk activities.

In summary, early findings and similar technologies suggest the BRAIN App is safe. However, ongoing studies will provide more detailed safety information. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The BRAIN App is unique because it uses artificial intelligence to tailor cognitive activities specifically to each person with dementia, based on their background, interests, and preferences. Unlike standard care options, which typically involve generic activities, this app adapts over time, learning from the user’s feedback to offer more engaging and potentially more effective mental exercises. Researchers are excited about this innovative approach as it could lead to more personalized and impactful interventions, potentially enhancing cognitive function and quality of life for those living with dementia.

What evidence suggests that the BRAIN App is effective for dementia?

Research has shown that the BRAIN App, available to participants in this trial, uses mobile technology to enhance thinking skills and slow memory loss. It employs artificial intelligence (AI) to customize activities based on individual interests, promoting engagement and commitment. Early results from a previous trial suggested that the app may improve quality of life and reduce behavioral issues in people with dementia. Studies indicate that digital therapy can enhance thinking skills in older adults with mild memory problems or dementia. Overall, the BRAIN App shows promise in supporting mental health and improving relationships among individuals with dementia, their professional caregivers, and family members. ^{6 7 8 9 10}

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

I cannot speak at all.

I have serious issues with my vision or hearing.

My health has quickly worsened over the past three months.

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

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]

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]

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]

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