Alzheimer’s disease Nervous System Diseases
Conditions
Interventions
At the start of the study, consenting individuals will provide one blood sample to be sent to UCLH for analysis. Basic information including age, sex, and ethnic group will be collected. The medical r
the remaining 50% at 12 months. The primary outcome will be the difference in the proportion of AD diagnoses between the two arms at 3 months. The total number of study visits will be 5. The baseline,
by telephone assessments at 6 and 15 months) and analysed by economists at the LSE.
A small number of individuals taking part will be offered the opportunity to be interviewed (either as individuals
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age >=50 years 2. Referred to NHS memory service, being seen for first appointment 3. Presence of a cognitive complaint by the patient (and/or study partner) 4. History of progressive decline in the opinion of the investigator 5. Objective evidence for impairment as evidenced by any of MMSE <28, MOCA <28, ACE-III <90, RUDAS <28 in an appropriate language 6. Alzheimer’s disease is a diagnostic consideration, with a presentation of either Mild Cognitive Impairment (MCI) or mild or moderate dementia 7. Able to nominate a study partner who has regular contact (at least weekly) 8. Willing and able to provide consent (including via a proxy)
Exclusion criteria
Exclusion criteria: 1. Normal cognition or subjective complaints that are not supported by cognitive testing 2. Amyloid status and/or plasma p-tau217 status already known to patient or referring clinician based on prior amyloid PET, CSF analysis or plasma biomarker 3. Lacks capacity to provide consent at recruitment visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Alzheimer’s disease diagnosis, measured as clinician assignment of diagnosis at 3 and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinician confidence in diagnosis of Alzheimer’s disease, measured on a Likert scale before and after consultation at 3 months and at 12 months 2. Change of diagnoses to or from Alzheimer’s disease, measured by change in clinician assignment of diagnosis at 3 and 12 months 3. Clinician activities indicating Alzheimer’s disease diagnosis: initiation of AD drug therapy, provision of AD post-diagnostic counselling, clinical trial referral, ascertained by collection of these data by case record forms from study clinicians and corroborated by local medication prescription records, at 3, 6, 12 and 15 months 4. Health-related quality of life, measured using the EQ5D-5L questionnaire at baseline, 3, 6, 12 and 15 months 5. Mean costs indexed by NHS and social care resource use and costs, measured using the Client Service receipt Inventory at baseline, 3, 6, 12 and 15 months | — |
Countries
England, Scotland, United Kingdom
Outcome results
None listed