Status:
COMPLETED
Evaluating the Relationship Between Tau PET Imaging and CSF Biomarkers of AD (Alzheimer Disease) in Humans
Lead Sponsor:
Tammie L. S. Benzinger, MD, PhD
Conditions:
Alzheimer Disease
Eligibility:
All Genders
65+ years
Brief Summary
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 wit...
Eligibility Criteria
Inclusion
- Male or female participants, at least 65 years of age.
- Participant is willing to undergo a lumbar puncture (LP) or has previously undergone LP. LP will be conducted under IRB ID 201109100 (PI: Anne Fagan).
- Participant is able and willing to undergo positron emission tomography (PET) and magnetic resonance imaging (MRI) of the brain.
- Pre-menopausal women must have a negative urine pregnancy test within 24 hours preceding T807 drug administration.
Exclusion
- Has any condition that, in the Investigator's opinion, could increase risk to the participant, limit the participant's ability to tolerate the experimental procedures, or interfere with the collection/analysis of the data (for example, participants with severe chronic back pain might not be able to lie still during the scanning procedures).
- Is deemed likely unable to perform the imaging procedures for any reason.
- Has a history of Torsades de Pointes or is taking medications known to prolong or may prolong QT interval (refer to study's list of restricted medications).
- Has known hypersensitivity to T807 or any of its excipients.
- Contraindications to PET, PET-CT or MR (e.g. electronic medical devices, inability to lie still for long periods) that make it unsafe for the individual to participate.
- Severe claustrophobia.
- Currently pregnant or breast-feeding. -
Key Trial Info
Start Date :
May 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 19 2021
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT03287765
Start Date
May 1 2016
End Date
July 19 2021
Last Update
May 8 2023
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110