Alzheimer Disease, Cognitive Impairment, Mild, Dementia, Mild
Conditions
Brief summary
This is an imaging study of patients with mild Alzheimer's disease receiving amyloid-targeting therapy and under the care of neurologists at Mayo Clinic in Rochester, MN.
Interventions
DRUG18F-AV-1451
Subjects will receive two Tau PET (18F--AV-1451) brain scans with approximately 10 mCi (370 MBq) (+/- 10%mCi) of 18F-AV-1451. Images will be collected for a 20-minute acquisition between 80-100 minutes after injection. Tau PET scans will occur at baseline and 12-18 months after completing anti-amyloid immunotherapy treatment..
Sponsors
Mayo Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Age 50-90 years * Male or female * Mild cognitive impairment due to AD or mild AD * Amyloid positive via CSF or PET * Meets other eligibility criteria for anti-amyloid immunotherapy * Subject or delegate provides informed consent
Exclusion criteria
* Subjects unable to lie down without moving for 10 minutes. * Women who are pregnant or cannot stop breast feeding for 24 hours. * Claustrophobic patients unable to tolerate the scans (no sedation can be offered).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in tau PET Standardized Uptake Value (SUVR) | Baseline, 18 months | A PET Standardized Uptake Value (SUV) is measured by calculating the ratio of the radioactivity concentration within a specific region of interest (ROI) on a PET scan, divided by the injected dose of the radiotracer per unit of the patient's body weight. The calculated Standardized Uptake Value (SUVR) is reported as a single number, with higher values indicating greater tracer uptake in the target region relative to the reference region |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects to develop amyloid-related imaging abnormalities (ARIA) | 18 months | ARIA is defined as edema (parenchymal edema or sulcal effusion, ARIA-E) and hemorrhage (microhemorrhages and superficial siderosis, ARIA-H). ARIA is detected on the patient's routine clinical brain MRIs. |
Countries
United States
Outcome results
None listed