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

NCT ID: NCT03287765

Last Updated: 2023-05-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 54 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2021-07-19

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Experimental 18F-AV-1451

18F-AV-1451

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Flortauapir

Eligibility Criteria

Inclusion Criteria

1. Male or female participants, at least 65 years of age.

2. 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).

3. Participant is able and willing to undergo positron emission tomography (PET) and magnetic resonance imaging (MRI) of the brain.

4. Pre-menopausal women must have a negative urine pregnancy test within 24 hours preceding T807 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 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).

4. Has known hypersensitivity to 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. -

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tammie L. S. Benzinger, MD, PhD

OTHER

Sponsor Role: lead

Responsible Party

Tammie L. S. Benzinger, MD, PhD

Professor of Radiology & Neurological Surgery

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Tammie Benzinger, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Other Identifiers

IND123119,Protocol F

Identifier Type: -

Identifier Source: org_study_id