RecruitingNot Applicable

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

United Kingdom120 participantsStarted 2026-05-05

Plain-language 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.

Who can participate

Age range

65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 * MC…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial seems to be focused on developing and testing a new computerised cognitive assessment tool for detecting very early Alzheimer's disease — before symptoms appear — so would my doctor think it's worth discussing whether my current cognitive status or family history makes me a relevant candidate to explore this kind of research?
2The trial is measuring a lot of unusual tests I haven't heard of before, like tasks involving animal-name matching, spatial binding, and motion pattern detection — can my doctor explain what these tests are actually trying to detect, and how they differ from the standard memory tests I might already be getting?
3Since this trial is listed as 'Phase NA,' which suggests it's more about developing and validating a new assessment tool than testing a treatment, can my doctor clarify that participating would not involve any experimental drug or therapy, and what the actual time commitment and experience of taking these tests would look like for me?
4Because this study appears to be about identifying Alzheimer's disease before obvious symptoms develop, should I ask my doctor whether learning my results from these experimental assessments might have emotional or practical implications — like effects on insurance or mental wellbeing — that I should think through before deciding whether to participate?
5Given that this trial is measuring cognitive performance but is not testing any treatment, my doctor and I should probably discuss whether there are other studies or clinical pathways that might be more relevant if I'm actually looking for access to an experimental therapy — can my doctor help me understand how this trial fits into the broader landscape of options available to me?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Matching Animals and Name Exam (MANE)

Timeframe: 12 month follow up assessment

Matching Animals and Names Exam - Total Binding Score

Timeframe: Baseline; repeat assessment at 12 months for a subset of participants.

Colour and Object Binding and Location Test trial 3

Timeframe: Baseline; repeat assessment at 12 months for a subset of participants.

Binding of Allocentric Spatial and Location Transformations (BASALT) total score

Timeframe: Baseline; repeat assessment at 12 months for a subset of participants.

False Familiarity Task

Timeframe: Baseline; repeat assessment at 12 months for a subset of participants.

Dichotic Sentence Identification score

Timeframe: Baseline; repeat assessment at 12 months for a subset of participants.

Dichotic Digits Test score

Timeframe: Baseline; repeat assessment at 12 months for a subset of participants.

Trial details

NCT IDNCT07598617

SponsorUniversity of Plymouth

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-02-01

Contact for this trial

Donnchadh Murphy, D.Clin.Psy

+44 1752 585858 donnchadh.murphy@plymouth.ac.uk

View on ClinicalTrials.gov More Alzheimer Disease (AD) trials

Plain-language summary

Who can participate

Age range

65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Matching Animals and Name Exam (MANE)

Timeframe: 12 month follow up assessment

Matching Animals and Names Exam - Total Binding Score

Timeframe: Baseline; repeat assessment at 12 months for a subset of participants.

Colour and Object Binding and Location Test trial 3

Timeframe: Baseline; repeat assessment at 12 months for a subset of participants.

Binding of Allocentric Spatial and Location Transformations (BASALT) total score

Timeframe: Baseline; repeat assessment at 12 months for a subset of participants.

False Familiarity Task

Timeframe: Baseline; repeat assessment at 12 months for a subset of participants.

Dichotic Sentence Identification score

Timeframe: Baseline; repeat assessment at 12 months for a subset of participants.

Dichotic Digits Test score

Timeframe: Baseline; repeat assessment at 12 months for a subset of participants.