NCT03545789

Phase 1 Test-retest Evaluation of [18F]MNI-958 PET

Phase 1 Test-retest Evaluation of [18F]MNI-958 PET as an Imaging Marker for Tau Protein in the Brain of Patients With Alzheimer's Disease and Probable PSP as Compared to Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Invicro · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The overall goal of this protocol is to evaluate \[18F\]MNI-958 also known as APN-0000455 or PM-PBB3, a tau targeted radiopharmaceutical.

Detailed description

The overall goal of this protocol is to evaluate \[18F\]MNI-958 also known as APN-0000455 or PM-PBB3, a tau targeted radiopharmaceutical. The specific objectives are: * To measure the dynamic uptake and washout of \[18F\]MNI- 958 in brain using positron emission tomography (PET) in patients with Alzheimer's disease, Progressive Supranuclear Palsy and healthy volunteers. * To measure blood metabolites of \[18F\]MNI-958 and perform kinetic modeling to assess its ability to measure tau protein in brain using the tracer plasma concentration or a reference region as indirect input. * To obtain test/retest reliability of the tracer binding parameters in patients with Alzheimer's disease, Progressive Supranuclear Palsy and healthy volunteers. * To acquire safety data following injection of \[18F\]MNI-958.

Conditions

• Healthy Volunteers
• Alzheimer Disease
• Progressive Supranuclear Palsy

Interventions

Type	Name	Description
DRUG	[18F]MNI-958	Subjects will undergo PET imaging using \[18F\]MNI-958, a PET radioligand for imaging tau.

Timeline

• Start date: 2018-03-12
• Primary completion: 2020-02-06
• Completion: 2020-02-06
• First posted: 2018-06-04
• Last updated: 2020-02-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study