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

NCT07598617 | Recruiting

• 2 other identifiers: 6703NIHR305222
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 3

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.

Conditions

Alzheimer Disease (AD)

Keywords

Preclinical Alzheimer's Disease

Outcome Measures

Primary Outcomes (11)

• 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.

Study Arms (1)

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.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• \>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)

You may not qualify if:

• 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.
• \>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)

Sponsors & Collaborators

• University of Plymouth: lead
• Devon Partnership NHS Trust: collaborator
• North East London Foundation Trust: collaborator

Study Sites (3)

University Hospitals Plymouth NHS Trust

Plymouth, Devon, Plymouth PL6 8BU, United Kingdom

RECRUITING

Research Delivery Team

Exeter, United Kingdom

RECRUITING

North East London NHS Foundation Trust

London, United Kingdom

NOT YET RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Nicolas Farina, PhD

  University of Plymouth

  STUDY DIRECTOR

Central Study Contacts

Donnchadh Murphy, D.Clin.Psy

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Clinical and Practitioner Academic Fellow

Study Record Dates

• First Submitted: May 9, 2026
• First Posted: May 20, 2026
• Study Start: May 5, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: May 20, 2026

Record last verified: 2026-05

Locations

GB (3)