Saint Louis, Missouri 63110


Purpose:

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 Dominantly Inherited Alzheimer's Disease) in the brain, and if the amount of tau tangles in the brain has a relationship to 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 may also be conducted.


Study summary:

The investigators hypothesize that in vivo tau imaging will ultimately: - Demonstrate the presence of tau fibrils in the brain during the pre-symptomatic stages of cognitive decline, prior to cerebral atrophy, hypometabolism (as measured by 18F-FDG PET imaging), and dementia. - Demonstrate that the phenoconversion from cognitively normal (CN) status to early stages of cognitive impairment will be closely correlated with neocortical F 18 T807 uptake and that amyloid positive CN individuals who are positive for F 18 T807 will demonstrate conversion to early dementia. - Correlate closely with the appearance of CSF markers of tau, including tau, p-tau, and VILIP-1. - Co-localize with specific cognitive deficits (i.e. patients with tau deposition in the left lateral temporal lobe will have primarily language deficits). - Predict the onset of dementia more accurately than existing biomarkers.


Criteria:

Inclusion Criteria: 1. Participants have met all eligibility criteria for enrollment into "Dominantly Inherited Alzheimer's Network (DIAN) Performance Site" (IRB ID: 201109187) 2. Male or female participants, at least 18 years of age 3. Cognitively normal, or with mild dementia, as assessed clinically 4. Participant is able and willing to undergo testing (MRI or CT, PET, radioactive tracer injection; for those unable to undergo an MRI, CT will be used to generate regions-of-interest). 5. Pre-menopausal women will undergo a urine pregnancy test within 24 hours of drug administration. Exclusion Criteria: 1. 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). 2. Is deemed likely unable to perform the imaging procedures for any reason. 3. Has a high risk for Torsades de Pointes or is taking medications known to prolong QT interval. 4. Has hypersensitivity to F 18 T807 or any of its excipients. 5. 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. 6. Severe claustrophobia. 7. Currently pregnant or breast-feeding.


NCT ID:

NCT02414178


Primary Contact:

Principal Investigator
Tammie Benzinger, MD, PhD
Washington University School of Medicine

Kelley Jackson, BA
Phone: 314 362 6737
Email: jacksonk@mir.wustl.edu


Backup Contact:

N/A


Location Contact:

Saint Louis, Missouri 63110
United States

Kelley Jackson
Phone: 314-362-6737
Email: jacksonk@wustl.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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