NCT07598617Toboroz

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

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. máj. 20.

Rövid összefoglaló (regiszter, angolul)

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.

Állapot (regiszter): Toboroz
Vizsgálattípus: Megfigyeléses
Résztvevők száma: 120 (tervezett)
Első benyújtás: 2026. máj. 9.
Kezdés: 2026. máj. 5.
Elsődleges befejezés: 2028. febr. 1.
Fő szponzor: University of Plymouth
Betegségek: Alzheimer-kór
NCT-szám: NCT07598617

Mit vállalsz

Vizsgálat típusa: Megfigyeléses
Tervezett résztvevők: 120
2026. máj. 5. és az elsődleges befejezés (2028. febr. 1.) között
3 helyszín, 1 országban
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Korábbi kezelés

Previous neurological injury (stroke, traumatic brain injury, severe epilepsy, brain tumour)
Current drug or alcohol abuse
Previous neurological injury (stroke, traumatic brain injury, severe epilepsy, brain tumour)
Current drug or alcohol abuse

Más betegség

Cognitive impairment, i.e., performance ≥1 SD below demographically adjusted norms (PROTECT) OR
Diagnosis of dementia
Sensory impairment that cannot be corrected for with sensory aids, e.g., blindness.
Other neurodegenerative syndrome (e.g., Parkinson's disease, multiple sclerosis, etc)
Current severe psychiatric disorder (bipolar disorder, schizophrenia, or psychotic disorders)
Untreated diagnosis of sleep apnoea.
- Mild Cognitive Impairment Inclusion Criteria
Cognitive impairment, i.e., performance ≥1 SD below demographically adjusted norms (PROTECT) OR
Diagnosis of dementia
Sensory impairment that cannot be corrected for with sensory aids, e.g., blindness.
Other neurodegenerative syndrome (e.g., Parkinson's disease, multiple sclerosis, etc)
Current severe psychiatric disorder (bipolar disorder, schizophrenia, or psychotic disorders)

Életkor

Age ≥65 years

Egyéb

≤17 on the telephone MoCA (non-PROTECT) AND
Lacks mental capacity to consent to research
Diagnosis of learning disability
Severe depression (PHQ-9≥15 OR score ≥1 on PHQ-9 suicide question
>3.38 on IQCODE Self-Report items 1-7 (PROTECT)
≥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
Onset of SCD within the last 5 years
English as a first language
Specific Race and Education (using stratified sampling approach)
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 learning disability
Severe depression (PHQ-9≥15 OR score ≥1 on PHQ-9 suicide question
Untreated diagnosis of sleep apnoea.

A regiszterben nem jelölt feltételek

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)

Életkor a regiszterben: 65 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (3)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

Helyszín	Város	Ország	Helyszín állapota
Research Delivery Team	Exeter	Egyesült Királyság	Toboroz
North East London NHS Foundation Trust	London	Egyesült Királyság	Toborzás még nem indult
University Hospitals Plymouth NHS Trust	Plymouth	Egyesült Királyság	Toboroz

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