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

NCT03287765 | Completed

• 1 other identifier: IND123119,Protocol F
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Alzheimer Disease

Keywords

Dementia; Tauopathies; cognitive impairment; CNS Diseases; neurodegenerative disease

Outcome Measures

Primary Outcomes (6)

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

  5 years

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

  5 years

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

  5 years

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

  5 years

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

  5 years

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

  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.

  5 years

Study Arms (1)

Experimental 18F-AV-1451

Drug: 18F-AV-1451

Interventions

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.

Also known as: Flortauapir

Experimental 18F-AV-1451

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Tammie L. S. Benzinger, MD, PhD: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Tauopathies; Cognitive Dysfunction; Central Nervous System Diseases; Neurodegenerative Diseases

Interventions

7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole

Condition Hierarchy (Ancestors)

Brain Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Tammie Benzinger, MD, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Radiology & Neurological Surgery

Study Record Dates

• First Submitted: October 31, 2016
• First Posted: September 19, 2017
• Study Start: May 1, 2016
• Primary Completion: May 1, 2021
• Study Completion: July 19, 2021
• Last Updated: May 8, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)