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Behavioural Intervention

Experimental, BRAIN Programming for Vascular Dementia

N/A
Waitlist Available
Research Sponsored by Hopeful Aging
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-intervention, that is, weeks 17-18
Awards & highlights

Study Summary

This trial aims to develop and evaluate a new digital therapy platform called "Building Relationships using Artificial Intelligence and Nostalgia" (BRAIN) for people living with dementia. The platform uses Artificial Intelligence

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
As this intervention involves a software platform rather than medication, traditional side effects are not expected. However, users may experience frustration or discomfort if they find the technology challenging to use.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-intervention, that is, weeks 17-18
This trial's timeline: 3 weeks for screening, Varies for treatment, and post-intervention, that is, weeks 17-18 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Engagement for Persons with Dementia Scale (EPWDS)
Menorah Park Engagement Scale (MPES)
Secondary outcome measures
Dementia Related Quality of Life (DEMQOL)
Mini-Mental Status Examination (MMSE) Mini-Mental Status Examination (MMSE)Mini-Mental Status Examination (MMSE)
Neuropsychiatric Inventory--Nursing Home (NPI-NH)
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental, BRAIN ProgrammingExperimental Treatment1 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 / CareActive Control1 Intervention
PLWD in the Control Group will participate in standard care / programming for 3 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
The BRAIN App
2022
N/A
~50

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Who is running the clinical trial?

Hopeful AgingLead Sponsor
5 Previous Clinical Trials
524 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available vacancies for patient participation in this clinical trial?

"As per the information available on clinicaltrials.gov, recruitment for this particular research endeavor is presently inactive. The trial details were first made public on February 15th, 2025, with the most recent update being on March 1st, 2024. While participation is currently not possible in this specific study, it's worth noting that there are a substantial number of 770 ongoing trials actively seeking participants."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
The BRAIN App (Phase 2 SBIR)
2025. "The BRAIN App (Phase 2 SBIR)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06298474.
~80 spots leftby Nov 2025
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