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

Condition(s) studied

Study 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.

Eligibility

Primary outcome measure(s)

• Memory Clinic Performance Metrics — From referral into the Memory Service through first Memory Clinic assessment (up to 12 months)
  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.
• Usability and Acceptability of Biomarker Enabled Approach-Clinician Feedback — Every 3 months throughout the study (up to 36 months)
  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.
• Health-Related Quality of Life (EQ-5D-5L) — Baseline (Study Visit 1), 2 weeks after return of results (Study Visit 3), and 12 months (Study Visit 4)
  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.
• Health-Related Quality of Life - Self Rated Overall Health (EQ VAS) — Baseline (Study Visit 1), 2 weeks after return of results (Study Visit 3), and 12 months (Study Visit 4)
  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.

Trial sites (12)

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