None listed
Conditions
Brief summary
New blood tests for detection of Alzheimer’s disease (AD), the most common cause of dementia, are becoming available, but are not yet approved for clinical use in Australia. Will they help GPs to diagnose the cause of memory problems? This study, run by the Australian Dementia Network and funded by the Commonwealth Department of Health and Aged Care, aims to answer this question. Participants are invited to take part in this research project because they have presented to their General Practitioner (GP) or practice nurse with concerns about cognition (i.e. memory or thinking). This research project will test if the new blood test for AD trial will help GPs to make a more confident and faster diagnosis of Alzheimer’s disease in patients in the early stages of this disease.
Interventions
Participants in this study will attend 3 visits of standard duration (10-20 minutes, per standard GP consult lengths) to their GP, one of these being in addition to standard care. They will also undergo a single blood draw between GP visits 2 and 3, in addition to standard care, to provide the sample on which the intervention will be administered. Participants will also attend a final visit of 60 minutes with a medical specialist (a neurologist, geriatrician or old age psychiatrist), per standar
Participants in this study will attend 3 visits of standard duration (10-20 minutes, per standard GP consult lengths) to their GP, one of these being in addition to standard care. They will also undergo a single blood draw between GP visits 2 and 3, in addition to standard care, to provide the sample on which the intervention will be administered. Participants will also attend a final visit of 60 minutes with a medical specialist (a neurologist, geriatrician or old age psychiatrist), per standard care. State coordinators will monitor each participants' progression through the study visits and blood draw/testing performed under this protocol and liaise with participants' referring GPs should the activities not be completed as scheduled. The intervention is the Roche Elecsys ptau217 plasma immunoassay for the detection of amyloid pathology. This diagnostic test will be administered at a single timepoint on blood samples of participants presenting to participating GPs for the investigation of cognitive decline. The test will be performed by an accredited laboratory at the Florey Institute of Neuroscience and Mental Health, with results provided to GPs to inform their patient diagnoses. Results of the assay will be made available to the participants' medical specialist and may be used by that specialist to assist diagnosis of Alzheimer's disease.
Sponsors
The University of Melbourne
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged at least 55 years. 2. Presenting with cognitive decline symptoms – self report or identified by a clinician or other reliable informant. 3. Montreal Cognitive Assessment (MoCA) score of 18 or more, or Mini-mental Status Examination (MMSE) score of 20 or more, or Rowland Universal Dementia Assessment Scale (RUDAS) score of 18 or more, plus a Geriatric Depression Scale (GDS) score of less than 8. 4. Patient is able to give informed consent.
Exclusion criteria
1. An established dementia diagnosis confirmed by a specialist. 2. Patients who do not agree to be informed of their blood biomarker result. 3. Persons at risk of suicide based on expression of intent to self-harm if found to have AD, suicide attempt in the past 5 years or current significant depression with suicidal ideation identified on the Columbia-Suicide Severity Rating Scale (C-SSRS)
Outcome results
None listed