Evaluation of Blood-Based Biomarkers and Remote Cognitive Assessment for Dementia Triage (SANDBOX)

NCT07842029 | Recruiting

• 2 other identifiers: SB-001347200
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 12

Brief Summary

Dementia is a leading cause of death in the UK, and long waits for diagnosis can delay access to care and treatment. The SANDBOX study is a research study in NHS Memory Clinics investigating whether providing clinicians with additional test results could help them diagnose dementia earlier. Adults aged 50 or over who have been referred to a Memory Clinic by their GP may be invited to take part. Taking part is voluntary and will not affect a participant's care. Participation adds to their NHS care and does not replace or delay it. Participants complete three assessments: a blood test that measures two proteins which can indicate whether Alzheimer's-related changes may be happening in the brain (not currently available on the NHS); a genetic test for the APOE gene, which influences Alzheimer's risk; and a cognitive assessment of memory and thinking that includes a recorded speech task analysed for subtle language changes. All results are shared with the participant's clinician. This research will help determine whether this approach can support earlier dementia diagnosis and improve care for patients across the UK.

Conditions

Dementia; Cognitive Impairment

Keywords

SANDBOX; dementia; cognitive impairment; cognitive decline; Alzheimer's; Neurodegeneration

Outcome Measures

Primary Outcomes (4)

• Memory Clinic Performance Metrics

  Time from the date of referral to the participant's Memory Clinic to the date of their first clinical assessment appointment. Reported as the mean number of days from referral to assessment.

  From referral into the Memory Service through first Memory Clinic assessment (up to 12 months)

• Usability and Acceptability of Biomarker Enabled Approach-Clinician Feedback

  Clinician feedback on the usability and acceptability of the biomarker-enabled approach is assessed using a structured questionnaire. Responses are recorded using categorical Likert-type scales (e.g., Very satisfied to Very dissatisfied), scored from 1 to 5, with higher scores indicating greater satisfaction or perceived effectiveness of the triage system. We will aggregate scores into a composite overall acceptability score.

  Every 3 months throughout the study (up to 36 months)

• Health-Related Quality of Life (EQ-5D-5L)

  Health-related quality of life measured using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L). The instrument includes five domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each scored on a 5-level scale ranging from 1 (no problems) to 5 (extreme problems). Domain responses are combined into a single EQ-5D-5L index score, where higher scores indicate better health-related quality of life.

  Baseline (Study Visit 1), 2 weeks after return of results (Study Visit 3), and 12 months (Study Visit 4)

• Health-Related Quality of Life - Self Rated Overall Health (EQ VAS)

  Self-reported health status measured using the visual analogue scale (VAS) of the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L). The VAS ranges from 0 to 100, where 0 represents the worst health imaginable and 100 represents the best health imaginable. Higher VAS scores indicate better self-reported health status.

  Baseline (Study Visit 1), 2 weeks after return of results (Study Visit 3), and 12 months (Study Visit 4)

Secondary Outcomes (15)

• Plasma Alzheimer's Disease Biomarkers (PrecivityAD2)

  Baseline (Study Visit 1) and 12 months (Study Visit 4)

• Epigenetic Biomarkers in Cell-Free DNA

  Baseline (Study Visit 1), 6 months (Study Visit 4), and 12 months (Study Visit 5)

• Digital Cognitive Testing Performance (CANTAB)

  Baseline (Study Visit 1), and 12 months (Study Visit 4)

• Voice-Based Biomarkers from Free Speech Analysis

  Baseline (Study Visit 1), and 12 months (Study Visit 4)

• Clinical and Demographic Data

  Study Visit 2, occurring at variable timepoints up to 12 months after baseline depending on clinic wait times

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults aged 50 years or older with subjective or objective cognitive impairment who have been referred to Memory Clinics for diagnostic clarification. Participants are recruited from Memory Clinic waiting lists across multiple NHS sites in England and Wales and are awaiting secondary care assessment for memory concerns. The study population includes individuals experiencing cognitive difficulties but without a prior dementia diagnosis.

You may qualify if:

• The participant is willing and able to provide informed consent for participation in the study, or if unable to consent, a consultee (nearest of kin or holder of Power of Attorney) is available to make a declaration.
• Eligibility for recruitment in Scotland is restricted to participants who are able to provide informed consent themselves; participants requiring consultee consent will not be recruited in Scotland.
• Male or female, aged 50 years or older.
• The participant is currently on a waiting list for a participating Memory Clinic.
• The participant lives within traveling distance to a study site.
• The participant agrees to complete all study procedures, including genetic testing.

You may not qualify if:

• The participant may not enter the study if any of the following criteria apply:
• The participant has known or anticipated challenges with venous blood sampling.
• The participant is not fluent in English.
• The participant has a historical diagnosis of dementia.

Sponsors & Collaborators

• Prima Mente: lead

Study Sites (12)

Imperial College Healthcare NHS Trust

London, Greater London, W6 8RF, United Kingdom

RECRUITING

Central and North West London NHS Foundation Trust

London, London, NW5 3EG, United Kingdom

RECRUITING

West London NHS Trust

London, London, UB1 3HW, United Kingdom

RECRUITING

Surrey and Borders Partnership NHS Foundation Trust

London, Surrey, KT22 7AD, United Kingdom

RECRUITING

Aneurin Bevan University Health Board Clinical Research Centre

Newport, Wales, NP20 2UB, United Kingdom

RECRUITING

Bradford District Care Foundation Trust

Bradford, BD9 6DP, United Kingdom

RECRUITING

Cwm Taf Morgannwg University Health Board

Bridgend, CF31 1RQ, United Kingdom

RECRUITING

Hywel Dda University Health Board

Llanelli, SA148QF, United Kingdom

ACTIVE NOT RECRUITING

Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust

Newcastle upon Tyne, NE4 5PL, United Kingdom

RECRUITING

Cardiff and Vale University Health Board

Penarth, CF64 2XX, United Kingdom

RECRUITING

Berkshire Healthcare NHS Foundation Trust

Reading, RG6 7BE, United Kingdom

RECRUITING

Swansea Bay University Health Board

Swansea, SA2 8PP, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

1. Samples will be retained: * Plasma samples from participants who provide consent will be retained for future research at the sponsor's laboratory (Prima Mente) * De-identified blood samples will be stored for long-term bio-banking 2. DNA extraction will be performed: * PAXgene® Blood DNA Tube (2.5 mL) collected specifically for APOE genotyping * Analysis of epigenetic markers in cell-free DNA * Whole Genome Sequencing (WGS) may be performed on a subset of samples

MeSH Terms

Conditions

Dementia; Cognitive Dysfunction; Nerve Degeneration

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Victoria B Medina, MRes

CONTACT

+447493339995; victoria@primamente.com

Hayley Holt, PhD

CONTACT

hayley@primamente.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Ivan Koychev

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: September 25, 2026
• Study Start: November 13, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (12)