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

Alzheimer Disease Clinical Trial

— Protocol E  

Official title:

F 18 T807 Tau PET Imaging of Progressive Posterior Cortical Dysfunction Due to Alzheimer Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02414282
• Other study ID #: IND 123119 Protocol E
• Status: Completed
• Start date: March 2015
• Est. completion date: October 20, 2020

Study information

• Verified date: January 2021
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 20, 2020
• Est. primary completion date: October 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

1. Male or female participants, at least 45 years of age.

2. Clinical diagnosis of PPCD.

3. 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).

4. Pre-menopausal women will have a negative urine pregnancy test within 24 hours of 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 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.

8. For those electing to undergo the optional lumbar puncture: on anticoagulant of any form prior to lumbar puncture.

Related Conditions & MeSH terms

• Alzheimer Disease
• Progressive Posterior Cortical Dysfunction (PPCD)

Intervention

Drug:
• F 18 T807
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.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Tammie L. S. Benzinger, MD, PhD

Country where clinical trial is conducted

United States, 

References & 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 Diso — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	F 18 T807 Standard Uptake Value Ratios (SUVR) will be correlated with other imaging modalities (MRI, PET amyloid imaging) and cognitive performance.		5 years