NCT07598617 · RECRUITING

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

This UK study is developing and testing a new computerized memory assessment designed to catch Alzheimer's disease at its earliest stages. The goal is to see whether memory nurses — rather than specialist doctors — can reliably administer this test, easing pressure on the NHS. It is not a drug trial. Participants complete a cognitive test, a brain scan, and a blood test. The phase is unspecified, meaning this is early-stage development and validation work, not a treatment study.

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.

The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.

Eligibility criteria as of 2026-05-20

View full record on ClinicalTrials.gov

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