None listed
Conditions
Brief summary
PET biomarkers (i.e. Aß and tau) are currently used to identify and characterise individuals with pre-clinical and clinical dementia, particularly Alzheimer's disease (AD), for research purposes. Therefore, to get a better understanding of dementia, it is desirable to evaluate separately both the brain distribution of Aß and tau accumulation. The primary aim of this phase II trial is to quantify global and regional Amyloid (Aß) and tau in older adults at various stages of dementia risk. Further, we aim to analyse how PET markers change over time. This will allow for comprehensive clinical characterisation of a sample of older adults at-risk for developing dementia. This 5-year study will recruit a subsample of participants involved in an ongoing long-term observational study being conducted through the Healthy Brain Ageing clinic, Sydney, Australia. Participants will be enrolled into the study after the informed consent process has been completed and met all inclusion criteria and none of the exclusion criteria. PET scans will be acquired at the imaging facility according to sites where PET tracers will be available (i.e. Macquarie University, Liverpool Hospital, Royal North Shore Hospital and North Shore Private Hospital). Depending on funding, tracer availability, and participant willingness, they may be offered follow-up scans every two years for the duration of the study, leading to a maximum of three scanning sessions over five years (Year 1, Year 3, Year 5).
Interventions
PET imaging (Aß and/or tau) session: PET biomarkers are currently used to identify and characterise individuals with pre-clinical and clinical dementia. Therefore, our aim is to quantify global and regional Amyloid (Aß) and tau burden in older adults at various stages of dementia risk.
Participants will undergo ONE Aß PET scan using [18F]-NAV4694 or [18F]-Florbetaben, as determined by site and subject to tracer availability. Participants may also undergo ONE tau PET scan using [18F]-MK6240, as
PET imaging (Aß and/or tau) session: PET biomarkers are currently used to identify and characterise individuals with pre-clinical and clinical dementia. Therefore, our aim is to quantify global and regional Amyloid (Aß) and tau burden in older adults at various stages of dementia risk. Participants will undergo ONE Aß PET scan using [18F]-NAV4694 or [18F]-Florbetaben, as determined by site and subject to tracer availability. Participants may also undergo ONE tau PET scan using [18F]-MK6240, as determined by site and subject to tracer availability. Depending on funding, tracer availability, and participant willingness, they may be offered follow-up scans every two years for the duration of the study, leading to a maximum of three scanning sessions over five years (Year 1, Year 3, Year 5). The imaging agent will be administered by a radiopharmacist and/or radiochemist or assigned Nuclear Medicine technologists on duty according to the below: [18F]NAV4694 – with the participants lying supine in a quiet room, 200 +/-10% MBq of [18F]NAV4694 will be injected via the inserted cannula followed by a saline flush of 20 mL. A 20-minute scan will be acquired starting at 50 min post injection of [18F]-NAV4694. OR [18F]-Florbetaben – with the participants lying supine in a quiet room 300 +/-10% MBq [18F] - will be injected via the inserted cannula followed by a saline flush of 20 mL. A 20-minute scan will be acquired starting at 90 minutes post injection of [18F]-Florbetaben. And, subject to availability, [18F]-MK6240 - 185 MBq of MK6240 will be injected via the inserted cannula followed by a saline flush of 20 mL. A 20-minute scan will be acquired starting at 90 minutes post injection of [18F]-MK6240.
Sponsors
The University of Sydney
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
50 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Adults aged between 50 and 90 years 2. Referred due to concerns about new onset of mood or cognitive problems (within the last 5-years) that are not due to other medical conditions 3. A MMSE score of greater than or equal to 20 (a widely used screening tool). 4. Willingness to give written informed consent and willingness to participate and comply with the study. 5. Have undergone the full Healthy Brain Ageing clinic assessment protocol including the collection of blood for genotyping. 6. Willing to undergo PET scanning within one month of Healthy Brain Ageing clinic assessment. 7. Subject to available funding. 8. Considered appropriate candidate by the treating clinician.
Exclusion criteria
1. Prior head injury (with loss of consciousness of greater than 30min) 2. Stroke 3. Major non-affective mental health disorder such as schizophrenia, Bipolar Disorder, ADHD, Autism, PTSD, chronic fatigue syndrome or acute psychosis 4. Major neurological condition such as Parkinson’s disease, epilepsy 5. Current or past alcohol or substance misuse 6. Intellectual disability 7. Currently taking benzodiazepines 8. Currently taking antipsychotics 9. Currently consuming more than 14 standard drinks of alcohol per week 10. Females who have not yet undergone menopause 11. A history of cancer diagnosis within the past 5 years 12. Current or prior kidney disease or any history of poor renal function that in the opinion of the investigator may deem it unsafe to participate in the study.
Outcome results
None listed