An observational study in Alzheimer Disease, sponsored by Tammie L. S. Benzinger, MD, PhD. Completed at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2023-05-08.
Sponsored by Tammie L. S. Benzinger, MD, PhD · Observational
The purpose of this research study is to evaluate a new radioactive compound used in positron emission tomography (PET) scans in identifying tau tangles (a certain protein that might be associated with Alzheimer's disease) in the brain, and if the amount of tau tangles in the brain has a relationship to cerebrospinal fluid (CSF) biomarkers and cognitive status.
This study involves a PET scans using the radioactive compound, F 18 T807 for measurement of tau deposition. This radioactive compound is not approved by the United States Food and Drug Administration (FDA). An MRI will be conducted if one has not been completed completed within the past 12 months under a related research study. Participants will be asked about their medical history, family history, surgical history, and current medications. We will evaluate history of traumatic brain injury (TBI) using the Ohio State University Traumatic Brain Injury Identification (OSU TBI-ID) Method. This will take approximately 10 minutes. Participants will be asked to undergo a Mini Mental State Examination (MMSE), which will last approximately 5-10 minutes.
Additionally, participants may be invited to undergo optional brain PET imaging with 2-deoxy-2-[18F]fluoro-D-glucose fludeoxyglucose (18F-FDG), for measurement of the cerebral metabolic rate of glucose consumption. At the time of the initial T807-PET study, participants will be asked if they are willing to undergo repeat T807-PET imaging at least 2 years after the initial study. This follow up study is optional, and participation in the study and initial T807-PET imaging will not be contingent on agreeing to the 2-year follow up study.
Under this study protocol, collaborating physicians and the Knight Alzheimer's Disease Research Center (ADRC) Clinical Core will refer participants to the Knight ADRC Research Imaging (KARI) Program for MR and PET imaging to evaluate tau distribution in the brains of cognitively normal and cognitively impaired individuals.
Exclusion Criteria:
Drug: 18F-AV-1451
Participants will receive a single intravenous bolus injection of approximately 6.5-10mCi (240-370MBq) of F 18 T807. For those who cannot tolerate the full exam, participants will receive single intravenous bolus injection of approximately 6.5-10mCi (240-370MBq) of F 18 T807.
Also known as: Flortauapir
Examine the association among T807-PET measures of PHF-tau.
Time frame: 5 years
Characterize the amount and spatial distribution of T807-PET measures in healthy aging. preclinical AD, and early symptomatic AD.
Time frame: 5 years
Characterize the amount and spatial distribution of T807-PET measures in preclinical AD.
Time frame: 5 years
Characterize the amount and spatial distribution of T807-PET measures in early symptomatic AD.
Time frame: 5 years
Examine the association among T807-PET measures of concentrations of CSF biomarkers. and cognitive performance.
Time frame: 5 years
Examine the association among T807-PET measures of cognitive performance.
Time frame: 5 years
Evaluate the change in T807-PET measures over time in asymptomatic amyloid-positive individuals and its association with changes in concentrations of CSF biomarkers.
Time frame: 5 years
Plan to share: Yes — The Investigators may share the participant's data with other researchers that may be doing research in areas similar to this research or in other unrelated areas. These researchers may be at Washington University, at other research centers and institutions, or industry sponsors of research. The Investigators may also share the research data with large data repositories (a repository is a database of information) for broad sharing with the research community. If the individual research data is placed in one of these repositories only qualified researchers will be able to look at the information.
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This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Tammie L. S. Benzinger, MD, PhD