CoCoA-PAD: Co-Produced Cognitive Assessment for Preclinical Alzheimer’s Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study uses a co-design approach with service users and memory nurses to develop and evaluate a new way to deliver comprehensive cognitive assessments within NHS memory services. It focuses on early-AD diagnosis by integrating cognitive testing with emerging biomarker considerations to improve predictive accuracy for progression to dementia. The study outlines eligibility criteria for older adults with subjective cognitive decline or mild cognitive impairment and describes collaborations between the University of Plymouth and NHS trusts. Interventions are not yet specified, with emphasis on implementation planning and workforce considerations to reduce delays in diagnosis and treatment.

Why it matters

Who can join: the full rules

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.

Where it's running

• University Hospitals Plymouth NHS Trust
  Plymouth, Devon, United Kingdom Recruiting
• Research Delivery Team
  Exeter, United Kingdom Recruiting
• North East London NHS Foundation Trust
  London, United Kingdom Not yet recruiting

Study contacts

• Study coordinator: Donnchadh Murphy, D.Clin.Psy
• Email: donnchadh.murphy@plymouth.ac.uk
• Phone: +44 1752 585858

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.