NCT07347431

Brief Summary

Dementia affects millions of people worldwide, and early diagnosis is essential for getting the right care and support. Doctors rely on collateral histories (accounts from family members or caregivers) to understand changes in a person's memory and thinking. However, these histories can be incomplete, unstructured, or difficult to obtain, making diagnosis more challenging. This study will test LUMEN (Large Language Model for Understanding and Monitoring Elderly Neurocognition), an AI-powered conversation tool designed to help caregivers describe their loved one's symptoms more effectively. By asking structured questions and guiding the conversation, LUMEN can create clear, well-organised reports for memory clinic doctors. This could make assessments quicker, more accurate, and less stressful for families. We will test LUMEN in real-world clinics by asking caregivers and doctors to use it and provide feedback. We want to understand how easy it is to use, whether it could improve the quality of information shared, and how it fits into existing NHS memory clinic processes. We will also run co-production workshops with community groups to ensure the tool is accessible to people from diverse cultural and language backgrounds. This research is exciting because it explores how artificial intelligence can improve dementia care. If successful, LUMEN could enhance the diagnostic process, reduce carer burden, and help more people access dementia support sooner. In the future, this tool could be used nationwide in memory clinics, improving care for thousands of families.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
8mo left

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress17%
Mar 2026Dec 2026

First Submitted

Initial submission to the registry

January 8, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 16, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

March 19, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

April 21, 2026

Status Verified

March 1, 2026

Enrollment Period

10 months

First QC Date

January 8, 2026

Last Update Submit

April 20, 2026

Conditions

Keywords

DementiaAlzheimer's DiseaseArtificial IntelligenceLarge Language Models

Outcome Measures

Primary Outcomes (2)

  • SUS (System Usability Scale)

    10-item Likert-scale questionnaire assessing ease of use (score ≥70 = good usability).

    Immediately after use of software

  • NASA-TLX (Task Load Index):

    Evaluates perceived cognitive workload (scores 0-29 = low workload).

    Immediately after prototype interaction

Other Outcomes (1)

  • Thematic analysis

    1-10 days after use of prototype software

Study Arms (2)

Patient-carer dyads

Carers (n=20-30 dyads): Recruited via Northumbria NHS Memory Clinics. Eligible carers will be adults (≥18 years) who know the patient well, have basic English literacy, and can provide informed consent. • Patients (n=20-30): Individuals (≥65 years) attending a memory clinic for cognitive assessment. 1. Baseline Data Collection: * Demographics (age, gender, ethnicity, socioeconomic status). * Clinical diagnosis (where available). * Cognitive test scores (MoCA/ACE). 2. LUMEN Interaction: o Carers will use LUMEN on a laptop or tablet to provide structured collateral histories (\~20-30 min). 3. Usability and Cognitive Load Assessment: * SUS (System Usability Scale): 10-item Likert-scale questionnaire assessing ease of use (score ≥70 = good usability). * NASA-TLX (Task Load Index): Evaluates perceived cognitive workload (scores 0-29 = low workload). 4. Qualitative Evaluation: * Semi-structured interviews (n=10 carers).

Other: LUMEN prototype software interaction

Clinicians

4.1. Participants and Recruitment • Clinicians (n=8-10): Specialists in dementia care (neurologists, psychiatrists, geriatricians, advanced nurse practitioners) with ≥2 years of experience. 4.2. Study Procedures 1. Baseline Data Collection: o Demographics (age, gender, ethnicity, socioeconomic status). 2. LUMEN Interaction: o Clinicians will review LUMEN-generated histories to assess completeness and clinical utility. 3. Usability and Cognitive Load Assessment: * SUS (System Usability Scale): 10-item Likert-scale questionnaire assessing ease of use (score ≥70 = good usability). * NASA-TLX (Task Load Index): Evaluates perceived cognitive workload (scores 0-29 = low workload). 4. Qualitative Evaluation: * Semi-structured interviews (n=4-5 clinicians).

Other: LUMEN prototype software interaction

Interventions

This is a prototype software which seeks to gather collateral information relevant to a dementia clinical assessment.

CliniciansPatient-carer dyads

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient and carer dyads: patients attending the Memory Clinic for assessment of cognitive problems. Clinicians: specialist doctors or advanced nurse practitioners responsible for dementia diagnosis

Carers of patients attending Memory Clinic appointments; Aged 18 or over; Both patients and cares can provide informed consent; Basic English literacy Clinicians must have at least 2 years of specialist dementia care experience and be personally responsible for dementia diagnosis; Must be provide informed consent

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

North Tyneside General Hospital is Rake Lane

North Shields, NE29 8NH, United Kingdom

RECRUITING

Related Links

MeSH Terms

Conditions

DementiaAlzheimer Disease

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersTauopathiesNeurodegenerative Diseases

Study Officials

  • Judith R Harrison, MBChB PhD

    Northumbria Healthcare NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2026

First Posted

January 16, 2026

Study Start

March 19, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

April 21, 2026

Record last verified: 2026-03

Locations