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NCT06298474 · ClinicalTrials.gov registry record · NA

The BRAIN App (Phase 2 SBIR)

A NA study of Alzheimer Disease and Dementia, sponsored by Hopeful Aging.

Recruiting
Registry status
NA
Development phase
120
Enrollment target
1
Study location

NCT06298474: Recruiting NA study of Alzheimer Disease and Dementia, sponsored by Hopeful Aging.

NCT06298474 is a NA study of Alzheimer Disease and Dementia that is actively recruiting participants, run by Hopeful Aging. The registered enrollment target is 120 participants, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06298474, a NA study of Alzheimer Disease and Dementia, is actively recruiting participants, sponsored by Hopeful Aging.

RECRUITING
Registry status
NA
Development phase
120 participants
Enrollment target
1
Study location

Study 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

Primary Outcome

The Menorah Park Engagement Scale measures four types of engagement. Constructive Engagement, Passive Engagement, Other Engagement, and Non-Engagement. It also measures pleasure. Scores on each type of engagement item range from 0 to 2 with higher scores indicating a better outcome for Constructive Engagement, Passive Engagement, and Pleasure. Higher scores represent worse outcomes for Distracted and Non Engagement.

Interventions

  • BEHAVIORAL The BRAIN App

Study Locations (1)

Massachusetts

  • Hopeful Aging - Winchester

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2025-05-15
Est. Completion 2026-07-30
Phase NA
Hopeful Aging

6 total trials

What NCT06298474 shows while recruiting

NCT06298474 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (96% lower).

The record links to 3 conditions, with Alzheimer Disease appearing as the primary indexed condition, and to 1 intervention - of which The BRAIN App is the first listed.

NCT06298474 reports a single indexed study location in Massachusetts.

Frequently Asked Questions

What is clinical trial NCT06298474 about?

NCT06298474 is a clinical study titled "The BRAIN App (Phase 2 SBIR)". 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 Associati...

What is the current status of trial NCT06298474?

This trial is currently recruiting. It is a NA study. The enrollment target is 120 participants. The study started on 2025-05-15. Estimated completion is 2026-07-30.

What conditions does trial NCT06298474 study?

This clinical trial studies the following conditions: Alzheimer Disease, Dementia, Vascular Dementia.

What interventions are being tested in trial NCT06298474?

The interventions under investigation include: The BRAIN App (BEHAVIORAL).

Who is sponsoring clinical trial NCT06298474?

This trial is sponsored by Hopeful Aging, which has 6 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06298474 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Alzheimer Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06298474's enrollment target sits among peer trials

120 139th of 306 higher than 162 of 306 other Alzheimer Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Alzheimer Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06298474, the US trial registry maintained by the National Library of Medicine. NCT06298474 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.