F 18 T807 Tau PET Imaging of Progressive Posterior Cortical Dysfunction (IND 123119, Protocol E)

NCT02414282 | Completed

• 1 other identifier: IND 123119 Protocol E
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This project will collect quantitative pilot data that will allow the characterization of uptake and binding of 18F-AV-1451 (also known as F 18 T807), a novel tau imaging compound, in individuals with Progressive Posterior Cortical Dysfunction (PPCD) and logopenic variant primary progressive aphasia (lvPPA). The primary goal is to develop tau imaging technique as an antecedent biomarker of cognitive decline. The investigators propose to obtain preliminary data that will support the possibility of detecting cognitive decline in its earliest stages, before the occurrence of dementia.

Conditions

Alzheimer Disease; Progressive Posterior Cortical Dysfunction (PPCD)

Keywords

Dementia; Brain Diseases; mild cognitive impairment; Central Nervous System Diseases; Neurodegenerative Disease

Outcome Measures

Primary Outcomes (1)

• F 18 T807 Standard Uptake Value Ratios (SUVR) will be correlated with other imaging modalities (MRI, PET amyloid imaging) and cognitive performance.

  5 years

Study Arms (1)

Experimental F 18 T807

Drug: F 18 T807

Interventions

F 18 T807 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: 18F-AV-1451

Experimental F 18 T807

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Collaborating physicians and the Knight 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, with the primary goal of developing this highly promising tau imaging technique as an antecedent biomarker of cognitive decline. We propose to recruit groups of patients with PPCD and lvPPA from the same clinical environment.

You may qualify if:

• Male or female participants, at least 45 years of age.
• Clinical diagnosis of PPCD.
• Participant is able and willing to undergo testing (MRI or CT, PET, radioactive tracer injection, LP; for those unable to undergo an MRI, CT will be used to generate regions-of-interest).
• Pre-menopausal women will have a negative urine pregnancy test within 24 hours of 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 high risk for Torsades de Pointes or is taking medications known to prolong QT interval.
• Has hypersensitivity to F 18 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.
• For those electing to undergo the optional lumbar puncture: on anticoagulant of any form prior to lumbar puncture.

Sponsors & Collaborators

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

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• Day GS, Gordon BA, Jackson K, Christensen JJ, Rosana Ponisio M, Su Y, Ances BM, Benzinger TLS, Morris JC. Tau-PET Binding Distinguishes Patients With Early-stage Posterior Cortical Atrophy From Amnestic Alzheimer Disease Dementia. Alzheimer Dis Assoc Disord. 2017 Apr-Jun;31(2):87-93. doi: 10.1097/WAD.0000000000000196.

  PMID: 28394771 RESULT

MeSH Terms

Conditions

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

Interventions

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

Condition Hierarchy (Ancestors)

Nervous System Diseases; Tauopathies; 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: April 7, 2015
• First Posted: April 10, 2015
• Study Start: March 1, 2015
• Primary Completion: October 20, 2020
• Study Completion: October 20, 2020
• Last Updated: January 19, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)