Evaluation of [123I] MNI-308 and SPECT as a Marker of Beta-amyloid Protein Deposition in AD Subjects Compared to HC
The main objectives of this proposal are as follows:
To assess the dynamic uptake and washout of 123-I MNI-308, a potential imaging biomarker for β-amyloid burden in brain, using single photon emission computed tomography (SPECT) in similarly aged Alzheimer's (AD) subjects and healthy controls
To perform blood metabolite characterization of 123-I MNI-308 in healthy and AD subjects to determine the metabolic fate and nature of metabolites in assessment of 123-I MNI-308 as a single photon computed tomography (SPECT) brain imaging agent
Evaluate the test/retest reproducibility of 123-I MNI-308 and SPECT in AD subjects and healthy control
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
|Official Title:||Evaluation of [123I] MNI-308 and SPECT as a Marker of Beta-amyloid Protein Deposition in Subjects With Alzheimer Disease in Comparison to Healthy Subjects|
|Study Start Date:||October 2007|
|Study Completion Date:||July 2008|
|Primary Completion Date:||October 2007 (Final data collection date for primary outcome measure)|
Drug: [123I] MNI-308
General Design and Methods. The underlying goal of this study is to assess 123-I MNI-308 SPECT imaging as a tool to detect ß-amyloid deposition in the brain of AD research participants and age- and gender-matched healthy subjects. All study procedures will be conducted at the Institute for Neurodegenerative Disorders (IND) and Molecular NeuroImaging (MNI) in New Haven, CT. Approximately 10 patients with Alzheimers disease (AD) and 6 healthy controls (within +/- 2 years) will be recruited to participate in this study. Healthy controls will be examined to ensure that there is no evidence of neurodegenerative changes including cognitive decline.
An interval of at least 14 days will lapse between dosing in the first four AD subjects. This is intended to provide a longer period for AE assessments. Once complete, absent any serious adverse events in these initial AD subjects, dosing may commence with the remainder of the subjects, including healthy controls.
Informed consent will be obtained for all subjects. All subjects will undergo a screening evaluation including baseline clinical laboratory testing, a baseline physical and neurological evaluation and baseline cognitive evaluations. Subjects will be asked to undergo a bolus injection of 123-I MNI-308. Subjects will undergo serial SPECT imaging scans and serial venous plasma sampling for measurement of 123-I MNI-308 in plasma (both protein bound and free) over a period of up to 8 hours. The imaging analyses will be performed by an image-processing specialist who will remain masked to the procedures employed with each imaging acquisition. The primary imaging outcome measure will be the brain regional distribution volumes expressed as a brain tissue to plasma ratio of the radioligand, 123-I MNI-308. Time to the peak uptake and amplitude of the peak uptake will be evaluated for all brain regions and the results for the AD patients and controls will be compared.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00544453
|United States, Connecticut|
|Institute for Neurodegenerative Disorders|
|New Haven, Connecticut, United States, 06510|
|Principal Investigator:||Danna L Jennings, MD||Institute for Neurodegenerative Disorders|