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

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.

Study Overview

• Status: Recruiting
• Conditions: Alzheimer Disease (AD)

Detailed Description

Alzheimer's disease (AD) healthcare is on the verge of significant change. Healthcare providers can now diagnose people with pre-dementia AD (i.e., preclinical and prodromal AD), and new disease modifying medications can slow cognitive decline. Health services are now faced with the challenge of implementing these developments into clinical practice. National Health Service (NHS) England and the National Dementia Team have developed an initial implementation strategy. It states that diagnostic assessments will be delivered in newly commissioned neurology and neuropsychology clinics, and that the completion of a 'comprehensive cognitive assessment' is required to diagnose the AD clinical syndrome, and stage the disease severity.

While AD biomarker assessments, such as plasma and cerebrospinal fluid assessments, provide information on the presence of AD pathology (Amyloid and Tau), they are not predictive of future dementia, i.e., only a proportion of 65-year-olds with preclinical AD biomarkers will develop Alzheimer's dementia in their lifetime. As such, the International Working Group (IWG) provide clear recommendations that the use of AD biomarkers in isolation in cognitive unimpaired older adults is not advisable and in fact may lead to harm. In contrast, meta-analytic research has demonstrated that the combination of biomarkers and cognitive assessments improves predictive accuracy for future AD dementia. The IWG have proposed that a clinical-biological definition of AD is adopted into clinical practice, and that the combination of plasma and sensitive cognitive markers of AD represent the most feasible strategy for a meaningful diagnosis of preclinical and prodromal AD.

The Implementation of Cognitive Assessment Pathways There are severe barriers to the implementation of comprehensive cognitive assessments for early AD into NHS practice. Most cognitive assessments are grossly insensitive to the early cognitive difficulties associated with AD and therefore not fit for purpose. Indeed, large scale research including over 5,000 participants, identified that traditional cognitive assessments do not add any predictive accuracy above demographic factors and genetics, to determine the risk of preclinical AD. There are some notable exceptions, but these rely on tests that can only be administered by practitioner psychologists, e.g., Logical Memory from Wechsler Memory Scales (WMS-IV). There is currently a national shortage of practitioner psychologists in the United Kingdom (UK). Two recent economic modelling studies demonstrate that the implementation of 'psychologist' delivered cognitive assessment onto early AD pathways would cost the NHS £4.2 billion to deliver, and without this investment, waiting lists would reach over 10 years by 2029. Therefore, the delivery of early AD cognitive assessment cannot be achieved by relying on existing cognitive tests or the existing workforce model. There is an urgent need for an implementation strategy for the delivery of large-scale cognitive assessment for early AD into the NHS, but there is no agreed upon strategy to achieve this.

Memory nurses are the largest staffing group in memory services and already have considerable experience administering and scoring brief cognitive screening tests, e.g., Montreal Cognitive Assessment (MoCA) and Addenbrooke's Cognitive Examination (ACE-III). Additionally, there is an impetus to increase the psychological workforce in the NHS through the delivery of the clinical associate psychologist (CAP) profession. In my opinion, the most realistic option of delivering comprehensive cognitive assessments at a large scale is to develop an assessment that can be reliably and robustly delivered by memory nurses and CAPs. Following consultation with memory nurses and neuropsychologists, there are two identified barriers to achieve this: 1) a lack of a standardised training protocol for non-practitioner psychologists on how to deliver cognitive assessments; and 2) a lack of available cognitive assessments that nurses and CAPs can use. This proposal seeks to co-design a nurse or non-practitioner psychologist administered cognitive assessment for preclinical AD, and co-produce a robust training protocol for nurses and allied health professionals to deliver cognitive assessments. If successful, this will contribute to the widespread delivery of early AD diagnosis and treatment through the NHS.

CoCoA-PAD Assessment The long-term aim of the Co-Production and Evaluation of the Computerised Cognitive Assessment for Preclinical Alzheimer's Disease (CoCoA-PAD) project is to develop a validated assessment app which can be used in clinical practice. The CoCoA-PAD project seeks to collate the best experimental neuropsychological tests in the academic literature, and work with a team of stakeholders to co-produce these tests into a viable clinical assessment. In its current format, the CoCoA-PAD assessment is experimental, and none of the subtests have been validated previously. Therefore, the CoCoA-PAD assessment in its current form is not a medical device and does not require Medicines and Healthcare products Regulatory Agency (MHRA) registration.

CoCoA-PAD is comprised of 16 standalone subtests, which are used to generate seven index scores (premorbid intelligence, memory, language and fluency, spatial processing, perceptual discriminability, cognitive control and performance validity). The CoCoA-PAD subtests are organised according to a theorised hierarchical structure. CoCoA-PAD is designed based on an up-to-date understanding of the cognitive neurology of preclinical and prodromal Alzheimer's disease and the temporal ordering of cognitive difficulties. The assessments have been designed to assess the cognitive sequelae of preclinical AD, and four preclinical syndromes.

CoCoA-PAD was designed to achieve two ambitions:

• Maximise Efficiency. CoCoA-PAD includes automatic and timed stimuli presentation, and automated scoring and psychometric calculations. This includes embedded machine learning approaches to maximise classification accuracy without the need for labour intensive scoring procedures. These steps ensure accuracy and reduce clinical time.
• Maximise Clinical Value. CoCoA-PAD incorporates many features that are designed to maximise clinical value, which do not exist in conventional neuropsychological assessments. This includes embedded measures of premorbid ability and performance validity, structured observational assessments of validity, functional cognitive disorder, and other cognitive difficulties, e.g., language.

2.3. Co-Production of CoCoA-PAD The CoCoA-PAD assessment battery, and indeed all aspects of this research study, have been developed using a coproduction methodology, as outlined by the National Institute for Health and Care Research (NIHR). The co-production group consists of five older adults (including two with neurological conditions, one from an ethnic minority background, and one with educational deprivation), five assistant psychologists, two memory nurses, and seven clinical psychologists and neuropsychologists. The older adult coproduction group are involved in ensuring the assessment is well tolerated, the instructions are clear, that the test does not unduly discriminate against people with low computer literacy. The assistant psychologist group are involved in coproducing the usability of the assessment for the examiner. The memory nurses are coproducing the clinical observation checklists. The clinical psychologist and neuropsychology group are involved in coproducing the assessment governance and training requirements. All aspects of the assessment have been or are currently being co-produced.

CoCoA-PAD is delivered using two platforms. Some subtests are delivered using the CoCoA-PAD web-based application, including Colour and Object Binding and Location Test (COBALT), Matching Animals Name Exam (MANE), Binding of Allocentric Spatial and Location Transformations (BASALT), Connected Speech, Clock Drawing. The remaining subtests are delivered using Gorilla Experiment Builder, an online platform for designing and running behavioural experiments. Gorilla Experiment Builder provides precise stimulus delivery, secure data collection, and easy remote access, making it well-suited for this research.

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

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

Study Locations

• United Kingdom
  • Exeter, United Kingdom
    • Recruiting
    • Research Delivery Team
    • Contact: Angela Holland, RN; Email: angela.holland5@nhs.net
  • London, United Kingdom
    • Not yet recruiting
    • North East London NHS Foundation Trust
    • Contact: Jane Burgess; Phone Number: 0300 300 1748; Email: Jane.Burgess@nelft.nhs.uk
  • Devon
    • Plymouth, Devon, United Kingdom, Plymouth PL6 8BU
      • Recruiting
      • University Hospitals Plymouth NHS Trust
      • Contact: Donnchadh Murphy, D.Clin.Psy; Phone Number: +44 1752 585858; Email: donnchadh.murphy@plymouth.ac.uk
      • Contact: Email: donnchadh.murphy@plymouth.ac.uk
      • Principal Investigator: Donnchadh Murphy, D.Clin.Psy
      • Sub-Investigator: Nicolas Farina, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Subjective cognitive decline (SCD) is a research descriptor used to refer to people who believe that their cognitive functioning has deteriorated despite performing in the 'normal' range on objective measures of cognitive functioning. People with SCD are at increased risk of developing dementia, and therefore SCD is considered a potential early clinical manifestation of Alzheimer's disease.

Mild Cognitive Impairment (MCI) is a descriptor used to refer to people who report experiencing a decline in cognitive functioning and demonstrate cognitive impairment on objective testing. It is thought to be a transitional phase between normal aging and dementia.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
At risk for Alzheimer's Disease; A mixed cohort of participants with either subjective cognitive decline (SCD+) or mild cognitive impairment will be recruited to the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Matching Animals and Name Exam (MANE)	Matching Animals and Name Exam (MANE) trial 2 learning score for both Set 1 and Set 2 stimuli. Scores range from 0 to 12, with higher scores indicating better learning performance.	12 month follow up assessment
Matching Animals and Names Exam - Total Binding Score	Matching Animals and Name Exam (MANE) binding scores. The task includes associative binding, temporal binding, and spatial binding scores. Each score ranges from 0 to 12, with higher scores indicating better binding performance. These scores are combined into a total binding score (0-36).	Baseline; repeat assessment at 12 months for a subset of participants.
Colour and Object Binding and Location Test trial 3	Colour and Object Binding and Location Test (COBALT) trial 3 object score. Scores range from 0 to 20, with higher scores indicating better object recognition performance.	Baseline; repeat assessment at 12 months for a subset of participants.
Binding of Allocentric Spatial and Location Transformations (BASALT) total score	Binding of Allocentric Spatial and Location Transformations (BASALT) total score. The score is calculated from four trials, each scored from 0 to 6. Total scores range from 0 to 24, with higher scores indicating better spatial binding and allocentric transformation performance.	Baseline; repeat assessment at 12 months for a subset of participants.
False Familiarity Task	False Familiarity Task false positive score. Scores range from 0 to 72, with higher scores indicating more false positive responses and poorer discrimination between previously presented and similar items. The primary outcome is the total number of mnemonic errors.	Baseline; repeat assessment at 12 months for a subset of participants.
Dichotic Sentence Identification score	Dichotic Sentence Identification score. The task includes left ear, right ear, and ear discrepancy scores. Left ear and right ear scores each range from 0 to 20, with higher scores indicating better sentence identification performance. The ear discrepancy score ranges from 0 to 20, with higher scores indicating a greater difference between left and right ear performance.	Baseline; repeat assessment at 12 months for a subset of participants.
Dichotic Digits Test score	Dichotic Digits Test score. The task includes left ear, right ear, and ear discrepancy scores. Left ear and right ear scores each range from 0 to 20, with higher scores indicating better digit identification performance. The ear discrepancy score ranges from 0 to 20, with higher scores indicating a greater difference between left and right ear performance.	Baseline; repeat assessment at 12 months for a subset of participants.
Odd-One-Out Test	Odd-One-Out perceptual discrimination. Scores range from 0 to 20, with higher scores indicating more errors and poorer perceptual discrimination performance. Additionally, we will be timing participants. Adjusted time to complete scores will also be recorded, with longer time associated with greater levels of difficulty.	Baseline; repeat assessment at 12 months for a subset of participants.
Verbal fluency semantic relatedness	Verbal fluency semantic relatedness score. This score will quantify the semantic relatedness of words generated during the verbal fluency task using a pre-specified analysis pipeline. Higher scores indicate greater semantic relatedness between generated words.	Baseline; repeat assessment at 12 months for a subset of participants.
Structure-from-Motion coherence threshold	Structure-from-Motion coherence threshold. Scores range from 0% to 100%, with higher scores indicating a higher coherence threshold and poorer structure-from-motion perception.	Baseline; repeat assessment at 12 months for a subset of participants.
Dynamic rotating Glass pattern coherence threshold	Dynamic rotating Glass pattern coherence threshold. Scores range from 0% to 100%, with higher scores indicating a higher coherence threshold and poorer dynamic form perception.	Baseline; repeat assessment at 12 months for a subset of participants.

Collaborators and Investigators

• Sponsor: University of Plymouth
• Collaborators: Devon Partnership NHS Trust; North East London Foundation Trust
• Investigators: Study Director: Nicolas Farina, PhD, University of Plymouth

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): September 30, 2028

Study Registration Dates

• First Submitted: May 9, 2026
• First Submitted That Met QC Criteria: May 15, 2026
• First Posted (Actual): May 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Preclinical Alzheimer's Disease
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease
• Other Study ID Numbers: 6703; NIHR305222 (Other Grant/Funding Number: National Institute of Health and Care Research (United Kingdom))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

IPD Plan Description

Access to identifiable data, audio recordings or raw data will be limited to named members of the study team. This data will not be shared with any external partners, nor any members on the project team, unless explicitly stated in the study protocol.

The CoCoA-PAD dataset will be shared in accordance with principles from the Open Science movement, supporting transparency, reproducibility, and wider scientific collaboration. The full research database will be deposited in a trusted institutional or subject-specific data repository, such as PEARL. Requests for access to the full anonymised database will be reviewed on a case-by-case basis. Access will be granted to qualified researchers who provide evidence of an appropriate data management plan, including commitments to ethical use, secure storage, and compliance with relevant data protection regulations. Requests for access will be reviewed by the sponsor and CI to ensure appropriate controls are in place. A data availability state

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No