Safety and Efficacy of Positron Emission Tomography (PET) Imaging With MNI-558
| Status: | Archived |
|---|---|
| Conditions: | Alzheimer Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | September 2010 |
| End Date: | February 2011 |
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
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.
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.
We found this trial at
1
site
Click here to add this to my saved trials
