NCT03239561

Evaluation of Tau Protein in the Brain of Participants With Alzheimer's Disease Compared to Healthy Participants

Phase 0 Exploratory Study of [18F]MNI-1020 (Also Known as [18F]JNJ-64326067) as an Imaging Marker for Tau Protein in the Brain of Subjects With Alzheimer's Disease Compared to Healthy Subjects

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

The primary objectives of this study are to characterize \[18F\]molecular neuroimaging (MNI)-1020, a positron emission tomography (PET) radioligand for imaging tau pathology, to visually and quantitatively assess and compare brain uptake and pharmacokinetics of \[18F\]MNI-1020 in participants with probable Alzheimer's disease (AD) and compare with age matched healthy participants, to evaluate the safety of a single injection of \[18F\]MNI-1020 and to compare the distribution of tau (using \[18F\]MNI-1020) and amyloid beta (using florbetapir) in participants with probable AD.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	[18F]MNI-1020	Participants will receive a single intravenous bolus injection of \[18F\]MNI-1020 at a dose of not more than 10 millicurie (mCi), with a maximum mass dose of 10 microgram (mcg) and maximum volume of 10 milliliter (mL) at imaging visit.

Timeline

• Start date: 2017-09-06
• Primary completion: 2018-04-30
• Completion: 2018-04-30
• First posted: 2017-08-04
• Last updated: 2025-04-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study