NCT00870519

Brain Imaging Study in Subjects With Alzheimer Disease in Comparison to Healthy Subjects

Evaluation of [123I] MNI-168 and SPECT as a Marker of Beta-amyloid Protein Deposition in Subjects With Alzheimer Disease in Comparison to Healthy Subjects

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Institute for Neurodegenerative Disorders · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

The underlying goal of this study is to assess 123-I MNI-168 SPECT imaging as a tool to detect ß-amyloid deposition in the brain of Alzheimer's Disease (AD) research participants and similarly aged and gender matched healthy subjects.

Detailed description

The overall research questions to be addressed by this protocol are as follows: * To assess the dynamic uptake and washout of (123I) MNI-168, a potential imaging biomarker for β-amyloid burden in brain, using single photon emission computed tomography (SPECT) in Alzheimer's (AD) subjects and similarly aged and gender matched healthy controls. * To perform blood metabolite characterization of (123I) MNI-168 in healthy and AD subjects to determine the metabolic fate and nature of metabolites in assessment of (123I) MNI-168 as a single photon computed tomography (SPECT) brain imaging agent. * To acquire initial safety data following injection of (123I) MNI-168. * Obtain test/retest reproducibility information in AD subjects with (123I) MNI-168 based on initial studies.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	I-123-MNI-168	Subjects will be injected with up to 5 mCi and not to exceed 5.5 mCi (not \>10% of 5 mCi limit) of 123-I MNI-168 followed by serial SPECT imaging.
DRUG	123-I MNI-168	Subjects will be injected with up to 5 mCi and not to exceed 5.5 mCi (not \>10% of 5 mCi limit) of 123-I MNI-168 followed by serial SPECT imaging.

Timeline

• Start date: 2009-01-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2009-03-27
• Last updated: 2019-04-03

Locations

1 site across 1 country: United States