NCT07598617 The Co-Production and Evaluation of the Computerised Cognitive Assessment for Preclinical Alzheimer's Disease (CoCoA-PAD)

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What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 120 participants in total. It began in 2026-05-05 with a primary completion date of 2028-02-01.

Brief Summary

Background. Healthcare professionals can now diagnose the earliest stages of Alzheimer's disease (early-AD) and new drugs are effective at slowing the disease. The National Health Service (NHS) in the United Kingdom has started to develop plans for how to implement these key achievements into clinical practice, so that patients can receive timely diagnosis and treatment. Cognitive assessments measure someone's memory and thinking skills and are required for an early-AD diagnosis. There are concerns that the NHS does not have the workforce to deliver cognitive assessments, and that this will delay early-AD diagnosis and treatment. Memory nurses are the largest staffing group in memory services. I have developed a plan for memory nurses to deliver full cognitive assessments. This would prevent delays to early diagnosis and treatment. Research Aims. This research will use a co-design approach. This involves working with service users and memory nurses to co-develop and evaluate a new cognitive assessment and cognitive training course for nurses. Research Methods. The cognitive assessment and training course will be evaluated using service-user and nurse feedback. 120 older adults with subjective memory complaints will be asked to complete a cognitive assessment, a brain scan, and a blood test. We will use this information to tell us if the cognitive assessment is good enough. Patient and Public Involvement. This proposal was co-developed with older adults and memory nurses. The adapted cognitive assessment and the cognitive training will be co-created with ten older adults and five memory-nurses, who will consult on all stages of the project. Dissemination. The research findings will be published in academic journals and conferences, and an information-sheet will be created for the public. The cognitive training resources will be made freely available. We will use the results of this research to request funding to translate the cognitive assessment into an NHS approved health-technology.

Eligibility Criteria

Recruitment Criteria for Subjective Cognitive Decline and Mild Cognitive Impairment Subjective Cognitive Decline Inclusion Criteria * \>3.38 on IQCODE Self-Report items 1-7 (PROTECT) OR * ≥4 on SCD-Q9 (non-Protect) AND * Age ≥65 years * Onset of SCD within the last 5 years * English as a first language * Normal demographically adjusted performance on standardised cognitive tests * Specific Race and Education (using stratified sampling approach) Exclusion Criteria * Cognitive impairment, i.e., performance ≥1 SD below demographically adjusted norms (PROTECT) OR * ≤17 on the telephone MoCA (non-PROTECT) AND * Lacks mental capacity to consent to research * Diagnosis of dementia * Sensory impairment that cannot be corrected for with sensory aids, e.g., blindness. * Previous neurological injury (stroke, traumatic brain injury, severe epilepsy, brain tumour) * Other neurodegenerative syndrome (e.g., Parkinson's disease, multiple sclerosis, etc) * Diagnosis of learning disability * Severe depression (PHQ-9≥15 OR score ≥1 on PHQ-9 suicide question * Current severe psychiatric disorder (bipolar disorder, schizophrenia, or psychotic disorders) * Current drug or alcohol abuse * Untreated diagnosis of sleep apnoea. Mild Cognitive Impairment Inclusion Criteria * \>3.38 on IQCODE Self-Report items 1-7 (PROTECT) * Cognitive impairment, i.e., performance ≥1 SD below demographically adjusted norms (PROTECT) OR * ≥4 on SCD-Q9 (non-PROTECT) * ≤17 on the telephone MoCA (non-PROTECT) OR * MCI diagnosis according to DSM or ICD-11 criteria through an NHS memory clinic. AND * Age ≥65 years * Onset of SCD within the last 5 years * English as a first language * Specific Race and Education (using stratified sampling approach) Exclusion Criteria * A score of ≥3 on any item on the Instrumental Activities of Daily Living scale, subject to clinical judgement. * Lacks mental capacity to consent to research * Diagnosis of dementia * Sensory impairment that cannot be corrected for with sensory aids, e.g., blindness. * Previous neurological injury (stroke, traumatic brain injury, severe epilepsy, brain tumour) * Other neurodegenerative syndrome (e.g., Parkinson's disease, multiple sclerosis, etc) * Diagnosis of learning disability * Severe depression (PHQ-9≥15 OR score ≥1 on PHQ-9 suicide question * Current severe psychiatric disorder (bipolar disorder, schizophrenia, or psychotic disorders) * Current drug or alcohol abuse * Untreated diagnosis of sleep apnoea.

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