NCT01217021

Safety and Efficacy of Positron Emission Tomography (PET) Imaging With MNI-558

An Exploratory, Open-label, Non-randomized Phase 0 Study to Evaluate Efficacy & Safety of MNI-558 Positron Emission Tomography for Detection/Exclusion of Cerebral Amyloid Beta in Patients w/ Alzheimer Disease Compared to Healthy Volunteers

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Institute for Neurodegenerative Disorders · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Accepted

Summary

This research will look at how the brain may change in people with Alzheimer disease (AD). The purpose of this research is to find out whether changes in the brain in people with Alzheimer disease can be detected using a brain imaging test. Most people with Alzheimer disease have changes in the brain that result in deposits of a protein called beta-amyloid. In this study, the investigators will be using a radioactive drug, \[18F\]MNI-558 that binds to beta-amyloid. This drug is experimental and has not been approved by the FDA. Brain imaging using PET (positron emission tomography) will be done to see if the investigators can evaluate the areas of beta-amyloid in the subjects with Alzheimer disease. The investigators will compare these scans with those done in healthy normal volunteers. PET is a brain-scanning test used in medicine and scientific research to see how the brain is working. The PET imaging test used in this study is not being done for diagnostic purposes.

Detailed description

This is a phase 0, open-label, single-center, non-randomized single dose study to assess the safety and efficacy of MNI-558 PET imaging in detecting amyloid beta plaque in the brain in patients with probable AD compared to HVs. All aspects related to image acquisition, processing and visual as well as quantitative evaluation will be developed, optimized and validated (where required). Each subject will be required to visit the study center during the screening phase, on the MNI-558 PET imaging day (baseline), and for 1 follow-up visit on the next day. A telephone follow-up visit will be performed 7 days after MNI-558 PET administration. At the screening visit, each subject and the caregiver will be asked to provide written informed consent or assent. During the screening phase (maximum duration - 28 days) subject medical, neurological and surgical history, clinical assessments and a neuro-psychiatric evaluation will be performed on all eligible subjects. Subjects will be allowed to leave the center after all evaluations have been completed. During this period an MRI of the brain must be performed. During the MNI-558 PET imaging day, all subjects will receive a single IV injection of IMP and scanning will be performed from 0-60 min, 75-135 min, and 150-210 min (p.i). Each subject will be asked to return to the site for a follow-up visit (20 to 28 hours after IMP administration) and a telephone follow-up will occur 7 days thereafter. Safety will be assessed during both follow-up visits.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	[18F] MNI-558	Subjects will be injected with 5mCi, not to exceed \>10% of 5mCI, of \[18F\]MNI-558, followed by PET imaging.

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2010-10-08
• Last updated: 2011-07-25

Locations

1 site across 1 country: United States