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Completed

NCT Number: NCT03287765

Evaluating the Relationship Between Tau PET Imaging and CSF Biomarkers of AD (Alzheimer Disease) in Humans

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.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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. -

Treatment and study plan

18F-AV-1451

Drug

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.

Other names: Flortauapir

Primary outcomes

  1. Examine the association among T807-PET measures of PHF-tau.

    Time frame: 5 years

  2. Characterize the amount and spatial distribution of T807-PET measures in healthy aging. preclinical AD, and early symptomatic AD.

    Time frame: 5 years

  3. Characterize the amount and spatial distribution of T807-PET measures in preclinical AD.

    Time frame: 5 years

  4. Characterize the amount and spatial distribution of T807-PET measures in early symptomatic AD.

    Time frame: 5 years

  5. Examine the association among T807-PET measures of concentrations of CSF biomarkers. and cognitive performance.

    Time frame: 5 years

  6. Examine the association among T807-PET measures of cognitive performance.

    Time frame: 5 years

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Tammie L. S. Benzinger, MD, PhD

Other

Registry information

Official study title

Evaluating the Relationship Between Tau PET Imaging and CSF Biomarkers of AD in Humans

Acronym: ADRCproj1

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Sep 19, 2017
Registry last updated
May 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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