Evaluation of Blood-Based Biomarkers and Remote Cognitive Assessment for Dementia Triage (SANDBOX)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorPrima Mente
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
From referral into the Memory Service through first Memory Clinic assessment (up to 12 months)2
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.
Time frame
Every 3 months throughout the study (up to 36 months)3
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.
Time frame
Baseline (Study Visit 1), 2 weeks after return of results (Study Visit 3), and 12 months (Study Visit 4)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.
Time frame
Baseline (Study Visit 1), 2 weeks after return of results (Study Visit 3), and 12 months (Study Visit 4)Secondary outcomes
1
Plasma Alzheimer's Disease Biomarkers (PrecivityAD2)
Plasma Alzheimer's disease biomarkers measured using the PrecivityAD2 blood test (C2N Diagnostics), including the amyloid beta 42/40 ratio (Aβ42/40), percent phosphorylated tau-217 (%p-tau217). The Amyloid Probability Score (APS2) is a composite algorithm score derived from these biomarkers and ranges from 0 to 100, correlated with clinical diagnosis and cognitive performance. Higher APS2 values indicate a greater likelihood of brain amyloid pathology consistent with Alzheimer's disease. APS2 values from 0-47 are interpreted as negative for brain amyloid plaques, while higher scores indicate increased probability of amyloid positivity.
Time frame
Baseline (Study Visit 1) and 12 months (Study Visit 4)2
Epigenetic Biomarkers in Cell-Free DNA
Methylation biomarkers in cell-free DNA analyzed by our models for associations with dementia-related clinical variables, including diagnosis and cognitive performance.
Time frame
Baseline (Study Visit 1), 6 months (Study Visit 4), and 12 months (Study Visit 5)3
Digital Cognitive Testing Performance (CANTAB)
Cognitive performance measured by CANTAB (Cambridge Neuropsychological Test Automated Battery) across multiple domains including episodic memory, visuospatial working memory, attention, associative learning, decision-making, visual-constructional ability, planning, processing speed, and task switching. Performance is reported as standardized z-scores and percentiles relative to an age-matched reference population. Z-scores range from negative to positive values, where 0 represents average performance; positive values indicate above-average cognitive performance and negative values indicate below-average performance.
Time frame
Baseline (Study Visit 1), and 12 months (Study Visit 4)4
Voice-Based Biomarkers from Free Speech Analysis
Speech parameters analysed from digitally recorded free speech tasks (narration of a complex scene with delayed repetition). Participants verbally describe the "cookie jar" scene and, after completing the CANTAB digital cognitive assessment, are asked to repeat the narration from memory. Speech recordings are analysed to derive quantitative speech parameters reflecting language production, including measures of fluency, lexical complexity, and acoustic features.These parameters are combined into a composite score reflecting evidence of dementia-related changes in speed, which is evaluated for associations with cognitive impairment.
Time frame
Baseline (Study Visit 1), and 12 months (Study Visit 4)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Prima Mente
Lead sponsor
Imperial College London
Sponsor institution
Source ClinicalTrials.gov