Enrolling by invitation NCT06723015
Tau PET Outcomes With Anti-amyloid Immunotherapies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 18F-AV-1451.
- Who it may be relevant to
- Registry conditions: Cognitive Impairment, Mild, Dementia, Mild, Alzheimer Disease. Basic parameters: 50 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Study of Tau PET Outcomes in Patients Receiving Anti-amyloid Immunotherapies
Overview
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
- Drug 18F-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..
Primary outcome measures
- Change in tau PET Standardized Uptake Value (SUVR) [Time frame: Baseline, 18 months]
Secondary outcome measures (1)
- Number of subjects to develop amyloid-related imaging abnormalities (ARIA) [Time frame: 18 months]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Mayo Clinic — Rochester
Identifiers
NCT: NCT06723015 · 24-004371