NCT01000870

Safety and Efficacy of Positron Emission Tomography Imaging With MNI-513

An Exploratory, Open-label, Non-randomized Phase 0 Study to Evaluate Efficacy & Safety of MNI-513 Positron Emission Tomography for Detection/Exclusion of Cerebral Amyloid Beta in Patients w/ Alzheimer Disease Compared to Healthy Volunteers

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Institute for Neurodegenerative Disorders · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to evaluate the efficacy and safety of MNI-513 positron emission tomography (PET) for detection/exclusion of cerebral amyloid beta in patients with Alzheimer's disease compared to healthy volunteers.

Detailed description

To determine diagnostic efficacy of the MNI-513 PET scans in differentiating between patients with probable AD and HVs on the basis of neocortical tracer binding pattern, the PET scans will be visually assessed by a nuclear physician experienced in the field of neuro-imaging. PET scan findings will be classified either as abnormal (i.e., significant neocortical uptake in predefined regions) or as normal (i.e. no significant neocortical uptake in predefined regions). The nuclear physician will be unaware of the clinical diagnosis.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	MNI-513-01	Subjects will be administered a single IV injection of IMP with a total activity amounting to 300MBq (8.1 mCi) +/- 20% of MNI-513 followed by PET imaging.

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2009-10-23
• Last updated: 2010-10-06

Locations

1 site across 1 country: United States