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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorUniversity of Plymouth

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥4 on SCD-Q9 (non-Protect) AND

Age ≥65 years

Onset of SCD within the last 5 years

English as a first language

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

120 Participants
are grouped into 1 trial group
Group A: At risk for Alzheimer's Disease

Trial outcomes

Primary outcomes

1

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.

Time frame
12 month follow up assessment
2

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).

Time frame
Baseline; repeat assessment at 12 months for a subset of participants.
3

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.

Time frame
Baseline; repeat assessment at 12 months for a subset of participants.
4

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.

Time frame
Baseline; repeat assessment at 12 months for a subset of participants.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Plymouth

Lead sponsor

Devon Partnership NHS Trust

Collaborator

North East London Foundation Trust

Collaborator