NCT02414178

F 18 T807 Tau PET Imaging in Dominantly Inherited Alzheimer's Network (DIAN Project)

F 18 T807 Tau PET Imaging in Dominantly Inherited Alzheimer's Network (IND 123119, Protocol D

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 130 (estimated)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 Dominantly Inherited Alzheimer's Disease) in the brain, and if the amount of tau tangles in the brain has a relationship to 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 may also be conducted.

Detailed description

The investigators hypothesize that in vivo tau imaging will ultimately: * Demonstrate the presence of tau fibrils in the brain during the pre-symptomatic stages of cognitive decline, prior to cerebral atrophy, hypometabolism (as measured by 18F-FDG PET imaging), and dementia. * Demonstrate that the phenoconversion from cognitively normal (CN) status to early stages of cognitive impairment will be closely correlated with neocortical F 18 T807 uptake and that amyloid positive CN individuals who are positive for F 18 T807 will demonstrate conversion to early dementia. * Correlate closely with the appearance of CSF markers of tau, including tau, p-tau, and VILIP-1. * Co-localize with specific cognitive deficits (i.e. patients with tau deposition in the left lateral temporal lobe will have primarily language deficits). * Predict the onset of dementia more accurately than existing biomarkers.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-03-01
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2015-04-10
• Last updated: 2025-06-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study