The BRAIN App (Phase 2 SBIR)
Hopeful Aging · NCT06298474
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 65+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Not applicable
- Target enrollment
- 120
- US sites recruiting
- 1
- Study start
- May 15, 2025
- Record last updated
- September 15, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: The BRAIN App
Conditions: Dementia; Alzheimer Disease; Vascular Dementia
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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)
Recruiting US locations
Hopeful Aging
Winchester, MA 01890
Site contact: Michael Skrajner, MA · 440-477-7881 · mike@hopefulaging.com
Similar studies in Massachusetts
All neurology studies in Massachusetts →- RecruitingHealthy volunteersPhase 1
Exploratory Clinical Study to Assess Safety and Efficacy of Xenon Gas Inhalation to Control Neuroinflammation
General Biophysics LLC
- Location
- Boston, MA
- Eligibility basics
- Ages 55–75
- RecruitingPhase 1/Phase 2Overnight stay mentioned
Study is to Assess the Safety and Tolerability of VTx-002 in Participants With ALS
Vector Y Therapeutics
- Location
- Boston, MA + 3 other US sites
- Eligibility basics
- Ages 18+
- RecruitingHealthy volunteersPhase 1
Investigating the Utility of Demyelination Tracer [18F]3F4AP in Controls and Multiple Sclerosis Subjects
Massachusetts General Hospital
- Location
- Boston, MA
- Eligibility basics
- Ages 18–65
- RecruitingHealthy volunteersEarly Phase 1
Transcranial Magnetic Stimulation Treatment for Alzheimer's Disease
Massachusetts General Hospital
- Location
- Boston, MA
- Eligibility basics
- Ages 40–99